Status:
COMPLETED
A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Lead Sponsor:
Celgene
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
CC-99282-CLL-001 study is a Phase IB dose escalation and expansion clinical study of CC-99282 administered in combination with Obinutuzumab in subjects with relapsed or refractory Chronic Lymphocytic ...
Detailed Description
All eligible subjects must be relapsed or refractory to at least 2 prior lines of therapy, one of which must have included an inhibitor of B-cell receptor signaling (approved Bruton's tyrosine kinase ...
Eligibility Criteria
Inclusion
- Subject is ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Must have a documented diagnosis of CLL/SLL requiring treatment (IwCLL Guidelines for the Diagnosis and Treatment of CLL). In addition presence of clinically measurable disease determined by at least one of the factors listed:
- nodal lesion that measures ≥ 1.5 cm in longest dimension (LD) and ≥ 1.0 cm in longest perpendicular dimension (LPD), or
- spleen that measures ≥ 14 cm in longest vertical dimension (LVD) with a minimum of 2 cm enlargement, or
- liver that measures ≥ 20 cm in LVD with a minimum of 2 cm enlargement, or
- peripheral blood B lymphocyte count \> 5000/uL
- All eligible subjects must be relapsed after or be refractory to \>2 prior lines of therapy one of which must have included an approved BTK inhibitor.
- Must meet the following laboratory parameters:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3 or ≥ 1000 cells/mm\^3 if secondary to bone marrow involvement by disease, without growth factor support for 7 days (14 days if pegfilgastrim).
- Platelet count ≥ 75,000 cells/mm\^3 (100 x 10\^9/L) or ≥ 50,000 cells/mm\^3 (50 x 10\^9/L) if secondary to bone marrow involvement by disease, without transfusion for 7 days.
- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) \< 3.0 x upper limit of normal (ULN).
- Serum bilirubin \< 1.5 x ULN unless due to Gilbert's syndrome.
- Calculated creatinine clearance of ≥ 60 ml/min.
Exclusion
- Presence of any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Prior allogeneic stem cell transplant (SCT)/bone marrow transplant within 12 months of signing the ICF. Subjects who received allogeneic SCT ≥ 12 months before signing the ICF may be eligible provided there is no ongoing graft-versus-host disease and no ongoing immune suppression therapy.
- Subject has received prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to starting CC-99282.
- Subject has received prior therapy with CRBN-modulating drug (eg, lenalidomide, avadomide/CC-122, pomalidomide) ≤ 4 weeks prior to starting CC-99282.
- History of second malignancies with life expectancy of ≤ 2 years or requirement of therapy that would confound study results.
- Peripheral neuropathy ≥ Grade 2.
- History of hypersensitivity to lenalidomide, pomalidomide, thalidomide.
- Impaired cardiac function or clinically significant cardiac disease.
- Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management.
- Active disease transformation (ie, Richter's Syndrome)
- Uncontrolled/active autoimmune hemolytic anemia or thrombocytopenia
Key Trial Info
Start Date :
December 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04434196
Start Date
December 21 2020
End Date
May 21 2024
Last Update
July 25 2024
Active Locations (15)
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1
Local Institution - 106
Boston, Massachusetts, United States, 02215
2
Local Institution - 104
Columbus, Ohio, United States, 43210
3
Local Institution - 101
Portland, Oregon, United States, 97201-3098
4
Local Institution - 107
Dallas, Texas, United States, 75390