A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period

Conditions

• Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Venetoclax — DRUG
  Venetoclax tablets will be administered as per the schedule specified in the arm.
• cBTKi Monotherapy — DRUG
  Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.

Study Details

The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease \[uMRD \< or 10\^-4 in peripheral blood (PB)\] by end of combination treatment (EOCT) to allow off-treatment period. The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.

Key Dates

Start date

Aug 9, 2024

Status verified

Feb 2026

Primary completion

Oct 31, 2026

Completion

Jan 31, 2030

Study Design

Enrollment

118 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Venetoclax Added to cBTKi (Commercially Prescribed)
  Participants will receive venetoclax, orally, once daily (QD) with a starting ramp-up dose of 20 milligrams (mg) on Day 1 of Cycle 1 (cycle length= 28 days). The dose will increase weekly; thereafter, treatment will continue with venetoclax at the target dose of 400 mg, QD from Week 5 up to Day 28 of Cycle 12. Participant will discontinue from venetoclax and/or cBTKi after 12 cycles. Participants with detectable measurable residual disease with the presence of less than 1 CLL cell in 10,000 leukocytes (\< 10\^-4) (MRD4) or uMRD4 with partial response (PR) may continue receiving cBTKi-monotherapy (i.e. ibrutinib or acalabrutinib, or zanubrutinib) as previously prescribed by the investigator according to the prescribing label.

Primary Outcome Measure

uMRD4 Rate at EOCT [ Time Frame: Cycle 12 Day 28 (Cycle length= 28 Days) ]

Locations (20)

Find similar trials in Springdale, AR

Related Studies

• A Long-term Extension Study of PCI-32765 (Ibrutinib)
  PHASE3 · Recruiting · Janssen Research & Development, LLC · Duarte, California
• Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
  PHASE1 · Recruiting · Baylor College of Medicine · Houston, Texas
• Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
  PHASE2 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Long-term Follow-up Study of Patients Receiving CAR-T Cells
  Recruiting · Medical College of Wisconsin · Milwaukee, Wisconsin