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Chemotherapy

Venetoclax + Chemotherapy for Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

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

For females of childbearing potential, a negative pregnancy test must be documented within 1 week of starting treatment

Patients with relapsed/refractory B- or T-cell ALL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am a woman who can have children and have a recent negative pregnancy test.

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My leukemia has returned or didn't respond to treatment.

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I can take care of myself but can't do heavy physical work.

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I will use effective birth control during and for 4 months after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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

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

Primary outcome measures

DLT (Phase I)

Maximum tolerated dose (MTD) (Phase I)

Secondary outcome measures

Duration of response (DOR)

Event-free survival (EFS)

Incidence of adverse events

+3 more

Other outcome measures

Apoptotic protein expression and Bcl-2 dependency

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

Neutrophil count decreased

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Pneumonia pseudomonal

11%

Hypokalaemia

11%

Dermatitis

11%

Rhinovirus infection

11%

Pneumonia

11%

Abdominal pain

11%

Anaemia

11%

Sepsis

11%

Gastroenteritis

11%

SARS-CoV-2 test positive

11%

Electrocardiogram QT prolonged

11%

Febrile neutropenia

11%

COVID-19

11%

Supraventricular tachycardia

100%

80%

60%

40%

20%

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: Experimental (venetoclax, vincristine, cyclophosphamide)Experimental Treatment10 Interventions

See Detailed Description.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

Dexamethasone

2007

Completed Phase 4

~2590

Nelarabine

2008

Completed Phase 2

~500

Pegaspargase

2005

Completed Phase 3

~9010

Methotrexate

2013

Completed Phase 4

~3800

Venetoclax

2019

Completed Phase 3

~1990

Cytarabine

2016

Completed Phase 3

~3310

Prednisone

2014

Completed Phase 4

~2370

Vincristine

2003

Completed Phase 4

~2910

Rituximab

1999

Completed Phase 4

~1880

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,752 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,655 Previous Clinical Trials

40,933,169 Total Patients Enrolled

Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center

16 Previous Clinical Trials

978 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

Frequently Asked Questions

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

Are there any other existing research projects that investigate Venetoclax?

"There are 2265 clinical trials currently underway for Venetoclax. Of these, 481 have reached Phase 3. 70387 different locations worldwide are running studies on this treatment, with a notable concentration in Changsha, Hunan."

Answered by AI

What is the usual purpose of Venetoclax?

"Venetoclax is most often used for the treatment of macular edema. It can also be used to treat conditions such as pheochromocytomas, eye, and ulcerative colitis."

Answered by AI

Are there any vacancies in this clinical trial for new patients?

"The latest information from clinicaltrials.gov suggests that this study is still looking for more participants. The original posting date was April 3rd, 2019 but the listing has been updated as recently as November 2nd, 2022."

Answered by AI

What aims does this experiment hope to achieve?

"The primary outcome of this study, which will be assessed over a Up to 28 days time frame is to Maximum tolerated dose (MTD) (Phase I). Secondary outcomes include Overall response rate (Phase II) which is defined as Will be defined as the percentage of patients achieving a complete response (CR) or CR with inadequate count recovery (CRi). Will estimate the overall response (OR) for the combination treatment, along with the 95% credible interval., Event-free survival (EFS) which is defined as The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher"

Answered by AI

How many research participants will be taking part in this investigation?

"That is accurate. The clinicaltrials.gov website has information revealing that this study, which was originally posted on April 3rd 2019, is still recruiting participants. They are looking for 50 individuals from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia

2019. "Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03808610.

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