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Alkylating Agent

Venetoclax + Chemotherapy Before Stem Cell Transplant for Leukemia

Q: For what purpose is Venetoclax most commonly prescribed?

Venetoclax is an effective treatment for allogeneic hematopoietic stem cell <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a>, chronic myelogenous <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, thrombocythemia, essential, and ctage1 protein, human.

Q: What other research has been done on Venetoclax?

As of right now, there are 665 different Venetoclax trials being conducted worldwide. 63 of those studies have progressed to Phase 3 clinical trials. The majority of these studies are based in Toronto, butVenetoclax research is taking place at 11891 locations globally.

Q: Are the participants in this research over 20 years old?

The age requirement for this particular study is 2 to 70. Out of 1008 similar studies, this one focuses on a demographic that 2732 other trials neglect.

Q: How many test subjects are a part of this clinical research?

Unfortunately, this clinical trial is no longer recruiting patients. Although it was first posted on October 27th, 2014 and last updated on October 6th, 2022, interested parties should look elsewhere for active trials. There are 2898 other trials involving preleukemia and 665 involving Venetoclax that are still looking for participants.

Q: Could you explain the risks associated with taking Venetoclax?

At Power, we believe that Venetoclax is a 2 in terms of safety. This is because it is still in Phase 2 testing, meaning that while there are data supporting its safety, there are no trials which have looked at its efficacy yet.

Q: Are investigators currently looking for new participants in this trial?

This study is no longer recruiting patients, as noted by the posting date of October 6th, 2022. If you are seeking other trials, 2898 studies for preleukemia and 665 for Venetoclax are currently enrolling patients.

Q: Could I possibly join this research project?

This study is looking for 116 patients that have preleukemia and meet the following age criteria: between 2 and 70 years old. It's important to note that some children may be eligible if they are unable to perform a pulmonary function test, have a pulse oximetry of 92% or higher on room air, and are ages 2-17 years old ( this will be determined in conjunction with an MDACC pediatrician). Additionally, at least 10 adults (ages 18-70) must have been assessed for safety at day 30 before any children can be enrolled.

Phase 2

Waitlist Available

Led By Uday R Popat

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

Performance score of >= 70 by Karnofsky/Lansky or performance status (PS) 0 or 1 (Eastern Cooperative Oncology Group [ECOG] =< 1)

Human leukocyte antigen (HLA)-identical sibling or 8/8 matched unrelated donor transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

Study Summary

This trial is testing a new chemotherapy regimen before a stem cell transplant to see if it can better kill cancer cells and help the stem cell transplant work better.

Who is the study for?

This trial is for adults aged 18-70 with acute myelogenous leukemia or myelodysplastic syndrome, either untreated or in remission. They must have a matched donor for stem cell transplant and good organ function (heart, liver, kidneys). Children may join after safety checks on adults. Exclusions include previous transplants, HIV positivity, severe comorbidities, uncontrolled infections, and heart disease.Check my eligibility

What is being tested?

The study tests venetoclax combined with chemotherapy (busulfan, cladribine, fludarabine phosphate) before a donor stem cell transplant to treat blood cancers. The goal is to see if this approach better eliminates cancer cells and supports healthy bone marrow growth compared to current methods.See study design

What are the potential side effects?

Potential side effects include reactions from the chemotherapy like nausea and fatigue; risks associated with stem cell transplantation such as infection risk due to immune suppression; possible damage to organs like the heart or liver; and complications from venetoclax including digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am mostly active and can care for myself.

Select...

I have a perfect match for a bone marrow transplant.

Select...

I have acute myeloid leukemia or myelodysplastic syndrome, either ongoing or in remission.

Select...

My child cannot do lung tests due to age but has a pulse oximetry of 92% or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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

Disease free survival (DFS)

Progression free survival

Secondary outcome measures

Cumulative incidence of acute graft versus host disease (GVHD)

Cumulative incidence of chronic GVHD

Cumulative incidence of relapse

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (busulfan days -20 and -13 before PBSCT)Experimental Treatment8 Interventions

PREPARATIVE REGIMEN: Patients receive venetoclax PO QD on days -22 to -3 and busulfan IV over 3 hours on days -20 and -13. Patients then receive fludarabine phosphate IV over 1 hour, cladribine IV over 2 hours, and busulfan IV over 3 hours on days -6 to -3. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.

Group II: Arm I (busulfan days -13 and -12 before PBSCT)Experimental Treatment8 Interventions

PREPARATIVE REGIMEN: Patients receive venetoclax PO QD on days -22 to -3 and busulfan IV over 3 hours on days -13 and -12. Patients then receive fludarabine phosphate IV over 1 hour, cladribine IV over 2 hours, and busulfan IV over 3 hours on days -6 to -3. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Cladribine

2014

Completed Phase 4

~4390

Busulfan

2008

Completed Phase 3

~1120

Venetoclax

2019

Completed Phase 3

~1990

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,551 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,686 Total Patients Enrolled

Uday R PopatPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

412 Total Patients Enrolled

Media Library

Busulfan (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02250937 — Phase 2

Myelodysplastic Syndrome Research Study Groups: Arm I (busulfan days -13 and -12 before PBSCT), Arm II (busulfan days -20 and -13 before PBSCT)

Myelodysplastic Syndrome Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT02250937 — Phase 2

Busulfan (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02250937 — Phase 2

Frequently Asked Questions

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

For what purpose is Venetoclax most commonly prescribed?

"Venetoclax is an effective treatment for allogeneic hematopoietic stem cell transplant, chronic myelogenous leukemia, thrombocythemia, essential, and ctage1 protein, human."

Answered by AI

What other research has been done on Venetoclax?

"As of right now, there are 665 different Venetoclax trials being conducted worldwide. 63 of those studies have progressed to Phase 3 clinical trials. The majority of these studies are based in Toronto, butVenetoclax research is taking place at 11891 locations globally."

Answered by AI

Are the participants in this research over 20 years old?

"The age requirement for this particular study is 2 to 70. Out of 1008 similar studies, this one focuses on a demographic that 2732 other trials neglect."

Answered by AI

How many test subjects are a part of this clinical research?

"Unfortunately, this clinical trial is no longer recruiting patients. Although it was first posted on October 27th, 2014 and last updated on October 6th, 2022, interested parties should look elsewhere for active trials. There are 2898 other trials involving preleukemia and 665 involving Venetoclax that are still looking for participants."

Answered by AI

Could you explain the risks associated with taking Venetoclax?

"At Power, we believe that Venetoclax is a 2 in terms of safety. This is because it is still in Phase 2 testing, meaning that while there are data supporting its safety, there are no trials which have looked at its efficacy yet."

Answered by AI

Are investigators currently looking for new participants in this trial?

"This study is no longer recruiting patients, as noted by the posting date of October 6th, 2022. If you are seeking other trials, 2898 studies for preleukemia and 665 for Venetoclax are currently enrolling patients."

Answered by AI

Could I possibly join this research project?

"This study is looking for 116 patients that have preleukemia and meet the following age criteria: between 2 and 70 years old. It's important to note that some children may be eligible if they are unable to perform a pulmonary function test, have a pulse oximetry of 92% or higher on room air, and are ages 2-17 years old ( this will be determined in conjunction with an MDACC pediatrician). Additionally, at least 10 adults (ages 18-70) must have been assessed for safety at day 30 before any children can be enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

2014. "Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02250937.

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