Trial Outcomes & Findings for Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma (NCT NCT01186458)
NCT ID: NCT01186458
Last Updated: 2016-10-24
Results Overview
To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
6 months
Results posted on
2016-10-24
Participant Flow
Participant milestones
| Measure |
Fludarabine, Velcade and Rituximab
Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Fludarabine, Velcade and Rituximab
Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Fludarabine, Velcade and Rituximab
n=4 Participants
Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.
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|---|---|
|
Age, Continuous
|
59.50 years
STANDARD_DEVIATION 14.01 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data for this primary objective was not collected or analyzed due to the termination of the study.
To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this secondary objective was not collected or analyzed due to the termination of the study.
To evaluate the progression-free survival and event-free survival in patients who receive therapy with fludarabine, Velcade, and rituximab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsTo evaluate the toxicity profile of this regimen. Adverse event counts by grade are presented.
Outcome measures
| Measure |
Fludarabine, Velcade and Rituximab
n=4 Participants
Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.
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|---|---|
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Toxicity
Total Adverse Events
|
122 number of adverse events
|
|
Toxicity
Grade 1 Adverse Events
|
77 number of adverse events
|
|
Toxicity
Grade 2 Adverse Events
|
35 number of adverse events
|
|
Toxicity
Grade 3 Adverse Events
|
9 number of adverse events
|
|
Toxicity
Grade 4 Adverse Events
|
1 number of adverse events
|
|
Toxicity
Grade 5 Adverse Events
|
0 number of adverse events
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this secondary objective was not collected or analyzed due to the termination of the study.
To explore the biologic interaction between fludarabine and Velcade and determine if Velcade can potentiate the DNA-damaging effect of fludarabine.
Outcome measures
Outcome data not reported
Adverse Events
Fludarabine, Velcade and Rituximab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fludarabine, Velcade and Rituximab
n=4 participants at risk
Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.
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|---|---|
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Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
|
25.0%
1/4 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Fludarabine, Velcade and Rituximab
n=4 participants at risk
Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.
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|---|---|
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Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
ANOREXIA
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Nervous system disorders
ATAXIA (INCOORDINATION)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
75.0%
3/4 • Number of events 12 • 6 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
CREATININE
|
25.0%
1/4 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
75.0%
3/4 • Number of events 6 • 6 months
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
100.0%
4/4 • Number of events 14 • 6 months
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
50.0%
2/4 • Number of events 3 • 6 months
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
75.0%
3/4 • Number of events 6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Cardiac disorders
HYPERTENSION
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Infections and infestations
INFECTION - OTHER
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AERODIGESTIVE NOS
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Nervous system disorders
LEUKOENCEPHALOPATHY (RADIOGRAPHIC FINDINGS)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
25.0%
1/4 • Number of events 7 • 6 months
|
|
Investigations
MAGNESIUM, SERUM-HIGH (HYPERMAGNESEMIA)
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
2/4 • Number of events 8 • 6 months
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
50.0%
2/4 • Number of events 10 • 6 months
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
25.0%
1/4 • Number of events 4 • 6 months
|
|
Eye disorders
NYSTAGMUS
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
PAIN / BACK
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
General disorders
PAIN / HEAD/HEADACHE
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Blood and lymphatic system disorders
PAIN / LYMPH NODE
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
PAIN - OTHER
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
PLATELETS
|
75.0%
3/4 • Number of events 6 • 6 months
|
|
General disorders
RIGORS/CHILLS
|
50.0%
2/4 • Number of events 4 • 6 months
|
|
Reproductive system and breast disorders
SEXUAL/REPRODUCTIVE FUNCTION - OTHER
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
SWEATING (DIAPHORESIS)
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Eye disorders
WATERY EYE (EPIPHORA, TEARING)
|
25.0%
1/4 • Number of events 1 • 6 months
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place