Phase 3
Completed N=120
A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
Source: ClinicalTrials.gov NCT03406156 ↗Enrolled (actual)
120
Serious AEs
10.8%
Results posted
Nov 2022
Primary outcomePrimary: Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period) — 81.4; 83.9; 88.3; 87.1 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a multi-cohort, open-label study in previously untreated participants with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), excluding those with the 17p deletion, to evaluate a debulking strategy that would enable all participants to receive subsequent venetoclax as outpatients, with lower risk of tumor lysis syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period) |
81.4; 83.9; 88.3; 87.1; 95.0; 90.3 | — |
| PRIMARY Complete Remission Rate |
51.2; 16.7 | — |
| SECONDARY Overall Response Rate (ORR) |
94.0; 88.9 | — |
| SECONDARY Duration of Response (DoR) |
21.7; NA | — |
| SECONDARY Progression-Free Survival (PFS) |
23.3; NA | — |
| SECONDARY Time to Progression (TTP) |
NA; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Undetectable Minimal Residual Disease (UMRD) Rate |
100; 100; 95.5; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Adequate hematology, kidney and liver function as described in the protocol
- Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1
- CLL/SLL requires treatment according to the IWCLL criteria
- Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] ≥ 25 × 10^9/L) OR High tumor burden (any LN ≥ 10 cm OR ALC ≥ 25 × 10^9/L and LN ≥ 5 cm)
Exclusion Criteria
- Presence of 17p deletion at Screening
- Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma)
- Prolymphocytic leukemia
Data sourced from ClinicalTrials.gov (NCT03406156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.