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Chemotherapy

Venetoclax + Chemotherapy for Leukemia

Phase 1 & 2
Recruiting
Led By Daniel DeAngelo, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with previously untreated acute lymphoblastic leukemia (B-cell or T-cell) with bone marrow involvement of ≥20% lymphoblasts and age ≥ 60 years
Patients with relapsed or refractory acute lymphoblastic leukemia (B-cell or T-cell) defined as receiving one or more cytotoxic containing regimens, with bone marrow involvement of ≥5% lymphoblasts, age ≥ 18 years, and Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Must not have
Ph-positive ALL, Burkitt's leukemia/lymphoma, or lymphoblastic lymphoma
Symptomatic or untreated leptomeningeal disease or spinal cord compression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is studying how well Venetoclax and standard chemotherapy work in treating patients with acute lymphoblastic leukemia.

Who is the study for?
This trial is for adults with untreated or relapsed/refractory acute lymphoblastic leukemia. Older patients (≥60 years) and those aged ≥18 with prior treatments can join if they have a certain level of bone marrow involvement, are in good physical condition, and have proper organ function. Participants must not be pregnant, agree to use contraception, and cannot have severe medical conditions that could affect the study.
What is being tested?
The trial is testing Venetoclax combined with standard chemotherapy drugs like cyclophosphamide and doxorubicin as a treatment for acute lymphoblastic leukemia. It aims to see how well this combination works in older patients or those who've had previous treatments without success.
What are the potential side effects?
Venetoclax and chemotherapy may cause side effects such as nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver issues reflected by altered blood tests, kidney dysfunction measured by creatinine clearance rates, and potential heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 or older with acute lymphoblastic leukemia that has not been treated and affects over 20% of my bone marrow.
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I am 18 or older with acute lymphoblastic leukemia that has not improved after treatment, can move around, and have more than 5% cancer cells in my bone marrow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My leukemia is Ph-positive ALL, Burkitt's, or lymphoblastic lymphoma.
Select...
I have symptoms or untreated issues with my brain or spinal cord.
Select...
I cannot take medications by mouth due to a digestive condition.
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I do not have any infections that are currently uncontrolled.
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I am currently taking warfarin.
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I have hepatitis B, hepatitis C, or HIV.
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I have not had major surgery or radiation therapy in the last 4 weeks.
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I do not have severe heart disease or recent major heart events.
Select...
I have been treated with venetoclax before.
Select...
I haven't taken strong CYP3A affecting drugs within 3 days before starting venetoclax.
Select...
My heart's pumping ability is below 40%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose
Secondary study objectives
Change in expression of BCL-2 family proteins: BAD
Change in expression of BCL-2 family proteins: BCL-2
Change in expression of BCL-2 family proteins: BCL-2 homology 3 (BH3)
+13 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Venetoclax + ChemotherapyExperimental Treatment2 Interventions
* Venetoclax is administered orally once daily for 21 days in each cycle * Standard Chemotherapy will be administered every 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Standard Chemotherapy
2006
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor
1,040 Previous Clinical Trials
523,497 Total Patients Enrolled
94 Trials studying Leukemia
11,952 Patients Enrolled for Leukemia
Dana-Farber Cancer InstituteLead Sponsor
1,113 Previous Clinical Trials
358,667 Total Patients Enrolled
80 Trials studying Leukemia
20,223 Patients Enrolled for Leukemia
Daniel DeAngelo, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
126 Total Patients Enrolled
2 Trials studying Leukemia
126 Patients Enrolled for Leukemia
Marlise Luskin, MD, MSCEPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Standard Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03319901 — Phase 1 & 2
Standard Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03319901 — Phase 1 & 2
Leukemia Research Study Groups: Venetoclax + Chemotherapy
Leukemia Clinical Trial 2023: Standard Chemotherapy Highlights & Side Effects. Trial Name: NCT03319901 — Phase 1 & 2
~13 spots leftby Apr 2026
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