Trial Outcomes & Findings for Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma (NCT NCT02737046)
NCT ID: NCT02737046
Last Updated: 2026-03-10
Results Overview
Number of participants achieving Complete Molecular Response after receiving protocol therapy will be reported. Complete Molecular Response (CMR) is defined as the disappearance of malignant clone(s), as proven by negative T-cell receptor gene rearrangement studies of peripheral blood DNA and bone marrow. CMR will be evaluated based upon T-cell clonality studies to be conducted while subjects are on Belinostat, and while subjects are receiving Zidovudine (AZT)-based maintenance treatment (after Belinostat completion).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
From end of cycle 3 until at least end of month 12
Results posted on
2026-03-10
Participant Flow
Participant milestones
| Measure |
Belinostat + Zidovudine
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Belinostat + Zidovudine
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lack of Efficacy
|
8
|
Baseline Characteristics
Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma
Baseline characteristics by cohort
| Measure |
Belinostat + Zidovudine
n=15 Participants
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=68 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=68 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: From end of cycle 3 until at least end of month 12Population: Participants that have received at least three (3) doses of Belinostat and Zidovudine (AZT) consolidation therapy, have evaluable disease at baseline, and at least one post-baseline molecular disease assessment.
Number of participants achieving Complete Molecular Response after receiving protocol therapy will be reported. Complete Molecular Response (CMR) is defined as the disappearance of malignant clone(s), as proven by negative T-cell receptor gene rearrangement studies of peripheral blood DNA and bone marrow. CMR will be evaluated based upon T-cell clonality studies to be conducted while subjects are on Belinostat, and while subjects are receiving Zidovudine (AZT)-based maintenance treatment (after Belinostat completion).
Outcome measures
| Measure |
Belinostat + Zidovudine
n=15 Participants
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR)
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 13 monthsPopulation: Participants that have received at least one dose of Belinostat and Zidovudine (AZT) consolidation therapy.
Number of participants experiencing treatment-related serious adverse events (SAEs), and adverse events (AEs). SAEs and AEs will be assessed by and assigned severity and treatment attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.
Outcome measures
| Measure |
Belinostat + Zidovudine
n=15 Participants
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Grade 1 or 2 Treatment-Related Serious Adverse Events (SAEs): Hematologic Events
|
0 participants
|
|
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Grade 1 or 2 Treatment-Related SAEs: Non-Hematologic Events
|
0 participants
|
|
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Grade 3 or 4 Treatment-Related SAEs: Hematologic Events
|
3 participants
|
|
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Grade 3 or 4 Treatment-Related SAEs: Non-Hematologic Events
|
0 participants
|
|
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Grade 1 or 2 Treatment-Related Adverse Events (AEs): Hematologic Events
|
10 participants
|
|
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Grade 1 or 2 Treatment-Related AEs: Non-Hematologic Events
|
15 participants
|
|
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Grade 3 or 4 Treatment-Related AEs: Hematologic Events
|
11 participants
|
|
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Grade 3 or 4 Treatment-Related AEs: Non-Hematologic Events
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants that receive at least one dose of Belinostat and Zidovudine (AZT) consolidation therapy, have evaluable disease at baseline, and at least one post-baseline clinical disease assessment.
Number of participants achieving complete response (CR) or partial response (PR) to study therapy will be reported. Response is assessed on the basis of clinical, radiologic, molecular and pathologic (i.e. bone marrow) criteria.
Outcome measures
| Measure |
Belinostat + Zidovudine
n=14 Participants
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Number of Participants Achieving Clinical Response
Participants achieving Complete Response (CR)
|
3 Participants
|
|
Number of Participants Achieving Clinical Response
Participants achieving partial response (PR)
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants that received at least one dose of Belinostat and Zidovudine (AZT) consolidation therapy.
The Failure-Free Survival (FFS) rate at 12 months estimated by the Kaplan-Meier method will be reported as a percentage probability of participants alive without documented disease progression, relapse after response or death (by any cause) at 12 months after starting study therapy. FFS is defined as the elapsed time in months from study treatment initiation until documented disease progression, relapse after response or death (by any cause, in the absence of progression). In the failure-free subjects, FFS will be censored at the last documented date of failure-free status.
Outcome measures
| Measure |
Belinostat + Zidovudine
n=15 Participants
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Failure-Free Survival (FFS) Rate at 12 Months Using Kaplan-Meier Method
|
27.4 percentage probability at 12 months
Interval 7.3 to 52.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants that received at least one dose of Belinostat and Zidovudine consolidation therapy.
The Overall Survival (OS) rate at 12 months estimated by the Kaplan-Meier method will be reported as the percentage probability of survival beyond 12 months. OS is defined as the elapsed time from study treatment initiation to death or date of censoring. Subjects alive or those lost to follow-up will be censored at the last date known to be alive.
Outcome measures
| Measure |
Belinostat + Zidovudine
n=15 Participants
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Overall Survival (OS) Rate at 12 Months Using Kaplan-Meier Method
|
80 percentage probability at 12 months
Interval 50.0 to 93.1
|
SECONDARY outcome
Timeframe: Up to 13 monthsThe number of participants exhibiting disruption of Human T-lymphotropic virus 1 (HTLV-1) latency in vivo after receiving Belinostat therapy will be reported. HTLV-1 latency will be evaluated from serum blood samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 13 monthsThe number of participants exhibiting cytotoxic T-Cell response in vivo after receiving Belinostat therapy will be reported. Cytotoxic T-Cell response will be evaluated from serum blood samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 13 monthsHTVL-1 pro-viral load among study participants will be reported as a measure of HTLV-1 infected reservoirs in vivo after receiving Belinostat therapy. HTLV-1 viral load will be evaluated from serum blood samples
Outcome measures
Outcome data not reported
Adverse Events
Belinostat + Zidovudine
Serious events: 7 serious events
Other events: 15 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Belinostat + Zidovudine
n=15 participants at risk
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Psychiatric disorders
Confusion
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Number of events 2 • 13 months
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Number of events 1 • 13 months
|
Other adverse events
| Measure |
Belinostat + Zidovudine
n=15 participants at risk
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
73.3%
11/15 • Number of events 46 • 13 months
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • Number of events 2 • 13 months
|
|
Psychiatric disorders
Anxiety
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 2 • 13 months
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Infections and infestations
Bronchial infection
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Infections and infestations
Catheter related infection
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
General disorders
Chills
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Psychiatric disorders
Confusion
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Number of events 4 • 13 months
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
3/15 • Number of events 3 • 13 months
|
|
Gastrointestinal disorders
Dental caries
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
3/15 • Number of events 3 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Nervous system disorders
Facial nerve disorder
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Number of events 2 • 13 months
|
|
General disorders
Fatigue
|
20.0%
3/15 • Number of events 4 • 13 months
|
|
General disorders
Fever
|
26.7%
4/15 • Number of events 9 • 13 months
|
|
General disorders
Flu like symptoms
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Gastrointestinal disorders
General disorders and administration site conditions - Other, specify
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Number of events 4 • 13 months
|
|
Hepatobiliary disorders
Hepatic pain
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.3%
2/15 • Number of events 3 • 13 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
3/15 • Number of events 4 • 13 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
3/15 • Number of events 3 • 13 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.3%
2/15 • Number of events 4 • 13 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
General disorders
Injection site reaction
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Investigations
Investigations - Other, specify
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Investigations
Lymphocyte count decreased
|
26.7%
4/15 • Number of events 13 • 13 months
|
|
Investigations
Lymphocyte count increased
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
General disorders
Malaise
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Infections and infestations
Meningitis
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Infections and infestations
Mucosal infection
|
13.3%
2/15 • Number of events 2 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
5/15 • Number of events 7 • 13 months
|
|
Investigations
Neutrophil count decreased
|
86.7%
13/15 • Number of events 69 • 13 months
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
General disorders
Pain
|
13.3%
2/15 • Number of events 3 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Infections and infestations
Papulopustular rash
|
6.7%
1/15 • Number of events 2 • 13 months
|
|
Cardiac disorders
Pericarditis
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Vascular disorders
Phlebitis
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Investigations
Platelet count decreased
|
73.3%
11/15 • Number of events 55 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Gastrointestinal disorders
Stomach pain
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
9/15 • Number of events 19 • 13 months
|
|
Investigations
White blood cell decreased
|
33.3%
5/15 • Number of events 17 • 13 months
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
3/15 • Number of events 3 • 13 months
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
1/15 • Number of events 1 • 13 months
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
2/15 • Number of events 3 • 13 months
|
|
Metabolism and nutrition disorders
Alkalosis
|
6.7%
1/15 • Number of events 1 • 13 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place