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Chemotherapy

Venetoclax + Chemotherapy for Acute Lymphoblastic Leukemia

Phase 1 & 2
Waitlist Available
Led By Elias Jabbour
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with relapsed/refractory B- or T-cell ALL
Performance status =< 3 (Eastern Cooperative Oncology Group [ECOG] Scale)
Must not have
Active serious infection not controlled by oral or intravenous antibiotics
Patients with Philadelphia chromosome-positive ALL or Burkitt leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of Venetoclax in combination with low-intensity chemotherapy in patients with B- or T-cell acute lymphoblastic leukemia.

Who is the study for?
This trial is for adults with B- or T-cell acute lymphoblastic leukemia that's come back or didn't respond to treatment. They must have acceptable liver and kidney function, not be pregnant, agree to use birth control, and can't have HIV, hepatitis B/C, a weak heart, prior venetoclax treatment, other serious cancers or bleeding disorders.
What is being tested?
The study tests the effectiveness of a drug called Venetoclax combined with low-intensity chemotherapy (including drugs like vincristine and methotrexate) on patients with relapsed/refractory acute lymphoblastic leukemia. It aims to find the best dose while assessing how well it stops tumor growth.
What are the potential side effects?
Potential side effects include nausea, fatigue, risk of infection due to lowered blood cell counts; organ damage; allergic reactions; hair loss from chemotherapy drugs; and possible complications from Venetoclax such as diarrhea and pneumonia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia has returned or didn't respond to treatment.
Select...
I can take care of myself but can't do heavy physical work.
Select...
I will use effective birth control during and for 4 months after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious infection that isn't getting better with antibiotics.
Select...
I have leukemia that is either Philadelphia chromosome-positive ALL or Burkitt.
Select...
I do not have severe heart failure.
Select...
I have been treated with venetoclax before.
Select...
I have a bleeding disorder not related to my cancer.
Select...
My heart's pumping ability is below 40%.
Select...
I have hepatitis B, C, or HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
DLT (Phase I)
Maximum tolerated dose (MTD) (Phase I)
Secondary study objectives
Duration of response (DOR)
Event-free survival (EFS)
Incidence of adverse events
+3 more
Other study objectives
Apoptotic protein expression and Bcl-2 dependency

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

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: Experimental (venetoclax, vincristine, cyclophosphamide)Experimental Treatment10 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Dexamethasone
2007
Completed Phase 4
~2650
Nelarabine
2008
Completed Phase 2
~500
Pegaspargase
2005
Completed Phase 3
~9260
Methotrexate
2019
Completed Phase 4
~4400
Venetoclax
2019
Completed Phase 3
~2200
Cytarabine
2016
Completed Phase 3
~3330
Prednisone
2014
Completed Phase 4
~2500
Vincristine
2003
Completed Phase 4
~2970
Rituximab
1999
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,063 Previous Clinical Trials
1,800,731 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,094 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
918 Total Patients Enrolled

Media Library

Cyclophosphamide, Dexamethasone, Methotrexate, Cytarabine, Prednisone, Vincristine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03808610 — Phase 1 & 2
Acute Lymphoblastic Leukemia Research Study Groups: Experimental (venetoclax, vincristine, cyclophosphamide)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Cyclophosphamide, Dexamethasone, Methotrexate, Cytarabine, Prednisone, Vincristine Highlights & Side Effects. Trial Name: NCT03808610 — Phase 1 & 2
Cyclophosphamide, Dexamethasone, Methotrexate, Cytarabine, Prednisone, Vincristine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808610 — Phase 1 & 2
~14 spots leftby Dec 2026
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