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BCL-2 Inhibitor

Venetoclax + Chemotherapy for Acute Lymphoblastic Leukemia

Phase < 1
Recruiting
Led By Jae Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0-2
Age 18-60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights

Study Summary

This trial is testing whether combining venetoclax with standard chemotherapy drugs is safe and effective in treating newly diagnosed acute lymphoblastic leukemia (ALL) in adults.

Who is the study for?
Adults aged 18-60 with newly diagnosed acute lymphoblastic leukemia (ALL), either T-cell or B-cell type, but without Philadelphia chromosome positive status. Participants must have good performance status, adequate kidney and liver function, and no active heart disease or other cancers. Pregnant women are excluded, and effective contraception is required.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of Venetoclax combined with standard chemotherapy in treating adults with newly diagnosed ALL. The goal is to determine if this combination improves outcomes compared to traditional treatments alone.See study design
What are the potential side effects?
Venetoclax may cause side effects such as nausea, diarrhea, low blood cell counts increasing infection risk, fatigue, potential liver issues indicated by abnormal blood tests, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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I am between 18 and 60 years old.
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I have ALL with CNS involvement and can get additional treatments for it.
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My kidneys are working well.
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I can take care of myself and am up and about more than half of my waking hours.
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I have been newly diagnosed with a type of leukemia that is not associated with the Philadelphia chromosome.
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My lymphoma does not affect my bone marrow.
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I have been newly diagnosed with a type of leukemia that is not associated with the Philadelphia chromosome.
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My liver is functioning well, with normal bilirubin and enzyme levels.
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I am between 18 and 60 years old.
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My kidneys are working well, with a creatinine clearance rate of 60 ml/min or more.
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My lymphoma does not affect my bone marrow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
proportion of patients who have a Dose Limiting Toxicities

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Anaemia
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
SARS-CoV-2 test positive
11%
Dermatitis
11%
Pneumonia
11%
Blood creatinine increased
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
COVID-19
11%
Supraventricular tachycardia
11%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: Venetoclax in Combination With ChemotherapyExperimental Treatment1 Intervention
All patients will complete Induction I and II of the treatment regimens, consisting of several chemotherapy agents including Peg-ASP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
597,695 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,741 Total Patients Enrolled
Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
14 Previous Clinical Trials
473 Total Patients Enrolled

Media Library

Venetoclax (BCL-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05386576 — Phase < 1
Acute Lymphoblastic Leukemia Research Study Groups: Venetoclax in Combination With Chemotherapy
Acute Lymphoblastic Leukemia Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT05386576 — Phase < 1
Venetoclax (BCL-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05386576 — Phase < 1

Frequently Asked Questions

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

What demographic is ideal for participating in this investigation?

"This clinical trial is accepting 12 individuals, between the ages of 18 and 60 with l1 acute lymphocytic leukemia. To be considered eligible for this study, participants must also satisfy these conditions: having T- or B-cell lymphoblastic lymphoma without bone marrow involvement; obtaining a performance status on ECOG scale from 0 to 2; showcasing sufficient renal function as attested by a creatinine clearance rate that surpasses 60 ml/min.; being newly diagnosed with Philadelphia chromosome (Ph) negative ALL; displaying adequate hepatic functioning as indicated by total bilirubin lower than 2.0 mg/dl (unless due to"

Answered by AI

Is this research endeavor open to those above the age of seventy?

"Participants aged between 18 and 60 are eligible for this clinical study. Alternatively, there exist 465 trials exclusively for minors and 1188 specifically designed to treat seniors."

Answered by AI

How many individuals are currently being accepted for enrollment in this research program?

"Affirmative. According to the clinicaltrials.gov database, this trial is presently open for participants and was first posted on June 16th 2022 before being revised a day later. A total of 12 patients must be recruited from one medical center."

Answered by AI

Are there any openings available in this medical experiment for participants?

"According to clinicaltrials.gov, the enrolment process of this study is still ongoing; it was first made available on June 16th 2022 and has since been modified on the following day."

Answered by AI
~1 spots leftby May 2024