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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 60 or older with acute lymphoblastic leukemia that has not been treated and affects over 20% of my bone marrow.
Select...
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
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%
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 + 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
950 Previous Clinical Trials
496,846 Total Patients Enrolled
85 Trials studying Leukemia
11,300 Patients Enrolled for Leukemia
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,791 Total Patients Enrolled
77 Trials studying Leukemia
10,338 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

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

Frequently Asked Questions

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

Are there any vacancies left in this clinical experiment?

"Affirmative, the data hosted on clinicaltrials.gov implies that this medical research is actively looking for candidates to enroll in the study. This trial was first posted on October 30th 2017 and saw its most recent update take place on October 3rd 2022. The team behind this investigation must recruit 82 participants across three sites."

Answered by AI

Are there any other investigations that have taken place in regards to Venetoclax?

"Venetoclax was pioneered by M D Anderson Cancer Center in the year 2014. Since then, there have been 56 successful trials and 219 ongoing ones, many of which are located within Houston's metropolitan area."

Answered by AI

What is the aggregate participant enrollment for this clinical trial?

"To fulfill the study requirements, 82 fitting subjects are needed to partake in this clinical trial. Patients can join from MD Anderson Cancer Center located in Houston, Texas and Dana Farber Cancer Institute based in Boston, Massachusetts."

Answered by AI
~1 spots leftby Apr 2024