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Bcl-2 Inhibitor

Venetoclax + Vincristine for Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

Led By Neil Palmisiano

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate liver function with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 3 X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing the effects of venetoclax and vincristine liposomal on patients with T-cell or B-cell acute lymphoblastic leukemia.

Who is the study for?

This trial is for adults with T-cell or B-cell acute lymphoblastic leukemia that has returned or isn't responding to treatment. Participants must not be pregnant, should use effective contraception, and have no severe active infections like poorly controlled HIV. They shouldn't have other serious medical conditions that could affect participation, nor a history of certain cancers unless cured over 5 years ago. Recent chemotherapy recipients and those with high-grade peripheral neuropathy are excluded.Check my eligibility

What is being tested?

The study is testing the combination of venetoclax, which blocks enzymes cancer cells need to grow, and vincristine liposomal, a chemotherapy drug that kills or stops cancer cells from dividing. The goal is to find the best dose of venetoclax and see if this combo works better for relapsed or refractory acute lymphoblastic leukemia.See study design

What are the potential side effects?

Potential side effects include risks typical of chemotherapy such as nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts; plus specific ones related to venetoclax like diarrhea and potential liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver tests are within normal limits.

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I am able to care for myself and perform daily activities.

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I do not have severe heart issues like advanced heart failure or uncontrolled chest pain.

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My kidney function is good, with a creatinine clearance of at least 50 mL/min.

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My cancer has not spread to my brain or testicles.

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I do not have Burkitt's lymphoma/leukemia.

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I am not pregnant or breast-feeding.

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My leukemia has returned or didn't respond to treatment, with more than 5% cancer cells in my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete remission (CR) + complete remission incomplete (CRi) rate (Phase II)

Incidence of toxicities (Phase I)

Maximum tolerated dose of venetoclax (Phase I)

Secondary outcome measures

Change in intracellular BCL-2 expression

Overall survival (OS)

Progression free survival (PFS)

+1 more

Other outcome measures

BH3 profile

Expression of BCL-2

Genetic signature

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (venetoclax, vincristine liposomal)Experimental Treatment3 Interventions

Patients receive venetoclax PO QD on days 1-42 of course 1 and days 43-70 of course 2. Patients also receive vincristine liposomal IV weekly for 4 weeks starting on day 14 of course 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,367 Total Patients Enrolled

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,848 Total Patients Enrolled

Neil PalmisianoPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Venetoclax (Bcl-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03504644 — Phase 1 & 2

Acute Lymphoblastic Leukemia Research Study Groups: Treatment (venetoclax, vincristine liposomal)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT03504644 — Phase 1 & 2

Venetoclax (Bcl-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03504644 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple sites in North America running this clinical experiment?

"This medical study has enrolled patients at 9 different sites across the U.S., including University of Pennsylvania/Abramson Cancer Center in Milwaukee, Medical College of Wisconsin in New Brunswick, and Rutgers Cancer Institute of New jersey in Hershey."

Answered by AI

Is there a current enrollment period for this experiment?

"The clinical trial, which was made available to the public on April 26th 2018, is still actively recruiting participants. As of January 23rd 2023 there have been no updates regarding changes in its parameters or timeline."

Answered by AI

Are there a specific number of participants being recruited for this experiment?

"This clinical trial requires 74 participants that meet the given eligibility requirements. Patients can join this medical study from University of Pennsylvania/Abramson Cancer Center in Milwaukee, Wisconsin and Medical College of Wisconsin in New Brunswick, New jersey or other approved sites."

Answered by AI

What diseases does Treatment (venetoclax, vincristine liposomal) typically treat?

"Venetoclax and vincristine liposomal are most frequently used to treat idiopathic thrombocytopenic purpura, but they can be applied to a variety of medical conditions such as advanced thymoma, small cell lung cancer, and acquired immunodeficiency syndrome."

Answered by AI

Could you elaborate on the other research done with venetoclax and vincristine liposomal?

"Presently, there are 434 clinical trials researching Treatment (venetoclax, vincristine liposomal), with 112 of them in the third stage. While Edmonton is home to many of these studies, 20218 other locations have active investigations into this treatment approach."

Answered by AI

What is the ultimate objective of this medical experiment?

"This research has a primary objective of determining the maximum tolerated dose of venetoclax during a 70 day period. The secondary objectives include ascertaining overall survival rates using Kaplan-Meier methodology, measuring rate of minimal residual disease with 95% confidence interval calculations, and assessing changes in BCL-2 expression by flow cytometry. To evaluate efficacy outcomes, univariate Cox proportional hazards models will be employed for OS and PFS while logistic regression models are utilized to investigate response at 70 days. Lastly, multivariable Cox PH modelling and logistic regression modelling will factor in any potentially associated covariates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax and Vincristine Liposomal in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

2018. "Venetoclax and Vincristine Liposomal in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03504644.

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