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

Korábbi kezelés

• 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.

Más betegség

• History of hypersensitivity to lenalidomide, pomalidomide, thalidomide.
• Impaired cardiac function or clinically significant cardiac disease.
• Active disease transformation (ie, Richter's Syndrome)
• Uncontrolled/active autoimmune hemolytic anemia or thrombocytopenia

Laborértékek

• Presence of any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

Életkor

• History of second malignancies with life expectancy of ≤ 2 years or requirement of therapy that would confound study results.

Egyéb

• Peripheral neuropathy ≥ Grade 2.
• Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management.

• 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.