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Safe Accelerated Venetoclax Escalation in CLL

NCT04843904 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-07

No results posted yet for this study

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

Conditions

Interventions

DRUG

Venetoclax

Tablet, taken by mouth

DRUG

Obinutuzumab

Given as an infusion into the vein (intravenous, IV).

DRUG

Rituximab

Given as an infusion into the vein (intravenous, IV).

Sponsors & Collaborators

Principal Investigators

  • Jennifer Crombie, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2025-06-02
Completion
2030-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04843904 on ClinicalTrials.gov