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Bending the Curve Trial by Trial
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A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma

Phase 1N = 116NCT01328626

Population
Adults with relapsed or refractory CLL or small lymphocytic lymphoma (SLL); the paper reports that 89% had poor prognostic clinical or genetic features.
Design
Single-arm phase 1 study of daily oral venetoclax: dose escalation (56 patients, eight dose groups from 150 to 1200 mg per day) and an expansion cohort (60 patients, weekly stepwise ramp-up to as high as 400 mg per day). ClinicalTrials.gov lists 222 actual enrolments across CLL and non-Hodgkin lymphoma; the paper reports the 116 patients with CLL or SLL who received venetoclax.
Arms
  • Venetoclax (experimental, n = 116): Oral venetoclax daily, 150 to 1200 mg in dose escalation; ramp-up to as high as 400 mg daily in the expansion cohort
People
Roberts AW, senior author Seymour JF
Show the numbers
Results reported for A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma
EndpointAnalysisVenetoclaxControlEffect
ORRPatients who received venetoclax (116)primaryRoberts 201679%—92 of 116 patients responded. Response rates ranged from 71 to 79% in subgroups with adverse prognosis (fludarabine resistance, deletion 17p, unmutated IGHV). Complete remission occurred in 20% of patients, including 5% with no MRD on flow cytometry.
PFS400-mg dose groupsprimaryRoberts 201669% at 15 mo—Estimate for the 400-mg dose groups only; the abstract gives no confidence interval.
Results reported for A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma
EndpointAnalysisVenetoclaxControlEffect
ORRPatients who received venetoclax (116)primaryRoberts 201679%—92 of 116 patients responded. Response rates ranged from 71 to 79% in subgroups with adverse prognosis (fludarabine resistance, deletion 17p, unmutated IGHV). Complete remission occurred in 20% of patients, including 5% with no MRD on flow cytometry.
PFS400-mg dose groupsprimaryRoberts 201669% at 15 mo—Estimate for the 400-mg dose groups only; the abstract gives no confidence interval.
Primary publication: Roberts AW, Davids MS, Pagel JM, Kahl BS, Puvvada SD, Gerecitano JF, et al. Targeting BCL2 with Venetoclax in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374(4):311-22. PubMedDOI

Appears in

Sources

  1. Roberts AW, Davids MS, Pagel JM, Kahl BS, Puvvada SD, Gerecitano JF, et al. Targeting BCL2 with Venetoclax in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374(4):311-22.

    PubMedDOI