A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination with Obinutuzumab (GA101) in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin*s Lymphoma

Completed

Conditions: DLBCL
iNHL
10025320

Registration Number: NL-OMON56451

Lead Sponsor: Celgene Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1. >= 18 years of age or older at the time of signing the informed consent
document., Entry Criteria Specific for Dose-Escalation Phase (Part A)
2. Subjects with CD20 positive, histologically or cytologically-confirmed,
DLBCL (including transformed low grade lymphoma) who have relapsed or
refractory disease following at least two prior standard treatment regimens
(eg, R-CHOP or similar first-line regimen and at least one second-line salvage
regimen) and/or ASCT in chemotherapy sensitive patients (see Protocol Section
7.2 for exceptions). , 3. Subjects with CD20 positive, histologically confirmed
(by WHO 2008 classification [Jaffe, 2009]), FL (Grade 1, 2, or 3a) or MZL who
have relapsed or refractory disease following at least one prior standard
systemic treatment regimen including systemic chemo-, immune-, or
chemoimmunotherapy., Entry Criteria Specific for Dose-Expansion Phase (Part B):
4.Subjects with CD20 positive, histologically confirmed FL (Grade 1, 2, or 3a)
who have relapsed or refractory disease following at least one prior standard
systemic treatment regimen including systemic chemo-, immune-, or
chemoimmunotherapy., Lenalidomide naïve
a. Relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a) following at
least one prior standard systemic treatment regimen including systemic chemo-,
immune-, or chemoimmunotherapy with no prior exposure to lenalidomide (FL-1
cohort). In addition, subjects must have received one prior line of salvage
therapy, unless ineligible for autologous transplant.
Lenalidomide exposed
b. Relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a) previously
treated with at least two cycles of lenalidomide-containing regimen (FL-2
cohort), either as a single agent or in combination, and experienced outcomes
to the lenalidomide treatment as follows:
- Early relapse after lenalidomide treatment
-Early progression after lenalidomide treatment
-Disease refractory to lenalidomide
- Lenalidomide or lenalidomide - containing regimen does not need to be the
immediate prior regimen received by the subject to be eligible for entry.,
Entry Criteria that apply to both Part A and Part B
5. Bi-dimensionally measurable disease with at least one lesion > 1.5 cm in the
transverse diameter.
- Measurable disease cannot be previously irradiated. , 6. ECOG PS of 0 to 1.
, 7. Subjects must have the following laboratory values at screening:
• Absolute Neutrophil Count (ANC) >= 1.5 x 10*9/L without growth factor support
for 7 days (14 days if subject received pegfilgrastim).
• Hemoglobin (Hgb) >= 8 g/dL.
• Platelets (plt) >= 50 x 10*9/L without transfusion for 7 days.
• Potassium within normal limits or corrected with supplements.
• AST/SGOT and ALT/SGPT <= 2.5 x Upper Limit of Normal (ULN) or <= 5.0 x ULN if
liver tumor is present.
• Serum bilirubin <=1.5 x ULN except in cases of Gilberts Syndrome, then <= 2.0
x ULN
• Estimated serum creatinine clearance of >= 60 mL/min using the Cockcroft-Gault
equation.

Exclusion Criteria

1. Prior ASCT <= 3 months before first dose.
2. Prior allogeneic stem cell transplant with either standard or reduced
intensity conditioning.
3. Prior systemic cancer-directed treatments or investigational modalities <= 5
half lives or 1 month prior to starting study drugs, whichever is shorter.
4. Prior radiotherapy within 1 month prior to starting study drugs.
5. A major surgery <= 2 weeks prior to starting study drugs. Subjects must have
recovered from any effects of recent surgery or therapy that might confound the
safety evaluation of study drug.
6. Prior treatment with CC-122 or obinutuzumab (GA101).
7. History of severe allergic or anaphylactic reactions to humanized monoclonal
antibodies.
a. Allergic to any excipients in obinutuzumab.
8. Treatment-related myelodysplastic syndrome.
9. Prior history of secondary malignancies (except for basal cell or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless
the subject has been free of the disease for >= 1 year prior to starting study
drugs.
10. Prior immunization with live virus vaccines (within 3 months prior to
starting study drug) or anticipated immunization with live virus vaccines
during the duration of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and tolerability will be assessed from AEs, laboratory tests, vital<br /><br>signs, ECGs, Eastern Cooperative Oncology Group Performance Status (ECOG PS),<br /><br>physical examinations, ophthalmologic exams, assessment of concomitant<br /><br>medications, and LVEF assessments. Adverse events will be evaluated using the<br /><br>National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events<br /><br>(CTCAE, Version 4.03) as a guide for the grading of severity.</p><br>

Secondary Outcome Measures