A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbVie
About this trial
This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must have an indication for treatment according to the 2008 Modified iwCLL NCI-WG Guidelines.
SLL participant must have measurable disease (B-lymphocytosis greater than 5 × 10^9/L or an enlarged lymph node(s) (Longest Diameter (LDi) > 1.5 cm at baseline) or hepatomegaly or splenomegaly due to CLL).
SLL participant must have presence of lymphadenopathy and absence of cytopenias caused by a clonal marrow infiltrate.
Participant must have relapsed or refractory CLL/SLL after receiving at least one prior line of therapy.
Disqualifiers
Participant has undergone an allogeneic stem cell transplant.
Participant has developed Richter's transformation confirmed by biopsy.
Participant has prolymphocytic leukemia.
Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP).
Trial design
Design model
Parallel
Treatments tested in this trial
Venetoclax
DrugTablet; Oral
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: VenetoclaxExperimental treatment 1 intervention
Group B: Cohort 2: VenetoclaxExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR)
ORR is the proportion of participants with an overall response (complete remission \[CR\], plus complete remission with incomplete bone marrow recovery \[CRi\], plus nodular partial remission \[nPR\], plus partial remission \[PR\]) per the National Cancer Institute-Working Group (NCI-WG) guidelines as assessed by the Independent Review Committee (IRC).
Time frame
Measured up to 2 years after the last participant has enrolled in the study.Secondary outcomes
1
Complete Response Rate (CRR)
CRR is defined as the proportion of subjects who achieved (CR + CRi) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) NCI-WG criteria.
Time frame
Measured up to 2 years after the last participant has enrolled into the study.2
Duration of Overall Response (DOR)
DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death
Time frame
Measured up to 2 years after the last participant has enrolled into the study.3
Progression Free Survival (PFS)
PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC) or death.
Time frame
Measured up to 5 years after the last participant has enrolled into the study.4
Event Free Survival (EFS)
EFS is defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy.
Time frame
Measured up to 5 years after the last participant has enrolled into the study. Source ClinicalTrials.gov