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

  • STATUS
    Recruiting
  • End date
    May 13, 2025
  • participants needed
    50
  • sponsor
    Celgene
Updated on 3 February 2021
platelet count
lymphoid leukemia
chronic lymphocytic leukemia
leukemia
gilbert's syndrome
neutrophil count
obinutuzumab

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 Leukemia/Small Lymphocytic Lymphoma.

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 inhibitor [BTKi] or Phosphoinositide 3-kinase inhibitor [PI3Ki]) or venetoclax. The dose escalation (Part A) will evaluate the safety, tolerability, and PK of escalating doses of CC-99282 given in combination with intravenous obinutuzumab to determine the MTD and RP2D of CC-99282 when given in combination with obinutuzumab.The dose expansion (Part B) may occur at the MTD established in the dose escalation phase, or at an alternative tolerable dosing schedule, based on review of safety, PK and PD data from Part A.

Details
Condition Lymphoma, Non-Hodgkin's Lymphoma, non-hodgkin's lymphoma (nhl)
Treatment Obinutuzumab, CC-99282
Clinical Study IdentifierNCT04434196
SponsorCelgene
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Non-Hodgkin's Lymphoma or Lymphoma?
Do you have any of these conditions: non-hodgkin's lymphoma (nhl) or Lymphoma or Non-Hodgkin's Lymphoma?
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/mm3 or 1000 cells/mm3 if secondary to bone marrow involvement by disease
Platelet count 100,000 cells/mm3 (100 x 109/L) or 50,000 cells/mm3 (50 x 109/L) if secondary to bone marrow involvement by disease
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 Criteria

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 ICD. Subjects who received allogeneic SCT 12 months before signing the ICD 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
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