OncRef

Clinical Trial: NCT04843904

Safe Accelerated Venetoclax Escalation in CLL

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Dana-Farber Cancer Institute
Information Provided By:Dana-Farber Cancer Institute
Last Update Posted:2026-01-07

Study Overview

Brief Summary

This research study is trying to determine which patients with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), as grouped by their risk for tumor lysis syndrome (TLS), are able to safely tolerate an accelerated, daily venetoclax dose ramp-up rather than the standard approved schedule (5-week dose ramp-up).

The name of the study drug involved in this study is:

  • Venetoclax

The following drugs may also be included in some participants treatment regimen:

  • Obinutuzumab
  • Rituximab

Official Title

SAVE (Safe Accelerated Venetoclax Escalation): A Phase Ib Study of Venetoclax Monotherapy With Accelerated Dose Ramp-up in Patients With CLL

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment

  • Drug: Venetoclax
  • Drug: Obinutuzumab
  • Drug: Rituximab

Other Study ID Numbers

  • 20-415

Start Date (Actual)

2021-04-14

Primary Completion Date (Actual)

2025-06-02

Study Completion Date (Estimated)

2030-06-02

Enrollment (Actual)

40

Study Type

Interventional

Phase

Phase 1