Trial Outcomes & Findings for 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation (NCT NCT03133221)
NCT ID: NCT03133221
Last Updated: 2025-06-27
Results Overview
The proportion of patients who discontinued the study due to Zydelig-related adverse events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
1 year.
Results posted on
2025-06-27
Participant Flow
Participant milestones
| Measure |
Oral Zydelig 150 mg BID
Zydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.
Zydelig: Zydelig given at 150mg continuously in 28-day cycles
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Oral Zydelig 150 mg BID
n=17 Participants
Zydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.
Zydelig: Zydelig given at 150mg continuously in 28-day cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Age, Continuous
|
60.82 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 year.The proportion of patients who discontinued the study due to Zydelig-related adverse events.
Outcome measures
| Measure |
Oral Zydelig 150 mg BID
n=17 Participants
Zydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.
Zydelig: Zydelig given at 150mg continuously in 28-day cycles
|
|---|---|
|
Discontinuation Rate Due to Zydelig-related Adverse Events at 1 Year
|
5 Participants
|
SECONDARY outcome
Timeframe: 1- and 2-year Progression-free survival1- and 2-year Progression-free survival; Progression-free survival is defined as time from the date of autologous stem cell transplantation to progression, relapse and death, whichever comes first.
Outcome measures
| Measure |
Oral Zydelig 150 mg BID
n=17 Participants
Zydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.
Zydelig: Zydelig given at 150mg continuously in 28-day cycles
|
|---|---|
|
Progression-free Survival at 1 and 2 Years After Autologous Stem Cell Transplantation.
2 year post transplant relapse
|
3 Participants
|
|
Progression-free Survival at 1 and 2 Years After Autologous Stem Cell Transplantation.
Progression-free survival
|
13 Participants
|
|
Progression-free Survival at 1 and 2 Years After Autologous Stem Cell Transplantation.
1 year post transplant relapse
|
1 Participants
|
Adverse Events
Oral Zydelig 150 mg BID
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Oral Zydelig 150 mg BID
n=17 participants at risk
Zydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.
Zydelig: Zydelig given at 150mg continuously in 28-day cycles
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
Other adverse events
| Measure |
Oral Zydelig 150 mg BID
n=17 participants at risk
Zydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.
Zydelig: Zydelig given at 150mg continuously in 28-day cycles
|
|---|---|
|
General disorders
Abdominal Pain
|
11.8%
2/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Infections and infestations
Acute bilateral maxillary sinusitis
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase Increased
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
ALT Decreased
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
ALT increase
|
23.5%
4/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Anorexia
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Arthralgia
|
11.8%
2/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
AST Decreased
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
AST Increase
|
29.4%
5/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Back pain
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Bruising
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Chills
|
11.8%
2/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Eye disorders
Conjunctival erythema
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Eye disorders
Conjunctival irritation
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Eye disorders
Conjunctivitis
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Cough
|
29.4%
5/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Creatinine decreased
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Creatinine increased
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Gastrointestinal disorders
Diarrhea
|
41.2%
7/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Ear and labyrinth disorders
Dry eyes
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Dysgeusia
|
23.5%
4/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Gastrointestinal disorders
Dyspepsia
|
17.6%
3/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Dyspnea
|
11.8%
2/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Gastrointestinal disorders
Esophagitis
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Fatigue
|
35.3%
6/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Headache
|
11.8%
2/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Hemoglobin Decreased
|
35.3%
6/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Gastrointestinal disorders
Herpatoxicity
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
41.2%
7/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
11.8%
2/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Hypokalemia
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
IgG deficiency
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Insomnia
|
29.4%
5/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Irritability
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Skin and subcutaneous tissue disorders
Lacerations (feet)
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
LDH decrease
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Mouth sore
|
11.8%
2/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Nail discoloration
|
11.8%
2/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Nausea
|
23.5%
4/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Neutrophils decreased
|
29.4%
5/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Night sweats
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Pain in extremities
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Skin and subcutaneous tissue disorders
Peripheral Edema
|
11.8%
2/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Skin and subcutaneous tissue disorders
Peripheral neuropathy
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Platelets decreased
|
41.2%
7/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic chest pain
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
17.6%
3/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Gastrointestinal disorders
Proctitis
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Skin and subcutaneous tissue disorders
Rash
|
52.9%
9/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Renal and urinary disorders
Renal insufficiency
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Restless leg syndrome
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Skin and subcutaneous tissue disorders
Scalp lesion
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Sinusitis
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Sore throat
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
Transaminitis
|
23.5%
4/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
29.4%
5/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Endocrine disorders
Urinary incontinence
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
Blood and lymphatic system disorders
WBC Decreased
|
35.3%
6/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
|
General disorders
Weight loss
|
5.9%
1/17 • 2 years post Autologous Stem Cell Transplantation (HDT/ASCT)
|
Additional Information
Jean Yared, MD
University of Maryland Greenebaum Comprehensive Cancer Center
Phone: 410-328-1230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place