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Alkylating agents

Venetoclax + Chemotherapy for AML and MDS

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
Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 50 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection
Therapy-related MDS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years post-transplant
Awards & highlights

Study Summary

This trial is studying venetoclax in combination with busulfan, fludarabine, and cladribine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell transplant.

Who is the study for?
This trial is for adults aged 18-70 with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), who've had previous treatments. Eligible participants must have certain genetic mutations, adequate liver and kidney function, and not be in complete remission. Pregnant women can't join, nor those with HIV, active infections, heart or lung issues below specified levels.Check my eligibility
What is being tested?
The study tests venetoclax combined with busulfan, cladribine, and fludarabine in patients undergoing stem cell transplant to treat AML/MDS. It aims to see if adding venetoclax improves outcomes compared to the standard care regimen.See study design
What are the potential side effects?
Potential side effects include reactions from chemotherapy like nausea, fatigue, low blood counts leading to increased infection risk; organ damage; allergic reactions; and complications from stem cell transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidneys work well, with a creatinine clearance rate of at least 50 mL/min.
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My condition is a type of blood cancer caused by previous cancer treatment.
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I am of childbearing age and not currently pregnant.
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My blood cancer is classified as high-risk based on specific tests.
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My leukemia is caused by previous cancer treatments.
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My AML developed from myelodysplastic syndrome or myeloproliferative disorder.
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My cancer is not in complete remission.
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My cancer did not fully respond to the first treatment.
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I have a high-risk form of myelodysplastic syndrome or CMML.
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I have acute myeloid leukemia and have had initial treatment.
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My cancer has specific gene mutations.
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I have a closely matched donor for a transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1-year progression free survival (PFS)
Secondary outcome measures
Graft-versus (vs.)-host disease-free, relapse-free survival (GRFS)
Incidence of acute and chronic graft-vs.-host disease (GvHD)
Incidence of adverse events
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (venetoclax, busulfan, fludarabine, cladribine)Experimental Treatment6 Interventions
Patients receive venetoclax PO QD on days -22 to -3, busulfan IV over 3 hours on days -20, -13, -6, -5, -4, and -3, and fludarabine phosphate IV over 1 hour and cladribine IV over 2 hours on days -6 to -3 in the absence of disease progression or unacceptable toxicity. Patients then undergo stem cell transplantation over 1-2 hours on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
2008
Completed Phase 3
~1120
Cladribine
2014
Completed Phase 4
~4390
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Thiotepa
2008
Completed Phase 3
~2150
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,678 Total Patients Enrolled
Uday R PopatPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
425 Total Patients Enrolled

Media Library

Busulfan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04708054 — Phase 2
Myelodysplastic Syndrome Research Study Groups: Treatment (venetoclax, busulfan, fludarabine, cladribine)
Myelodysplastic Syndrome Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT04708054 — Phase 2
Busulfan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04708054 — Phase 2

Frequently Asked Questions

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

Are elderly individuals over 80 years of age being included in this examination?

"This study is open to adults between the ages of 18 and 70. For those younger than 18, there are 995 studies available; conversely, 2651 medical trials can be found for individuals above 65 years old."

Answered by AI

Are there any criteria that must be met to partake in this medical experiment?

"Patients with a myeloid form of leukemia that are between the ages of 18 and 70 can apply for this trial, which is recruiting up to 100 participants."

Answered by AI

Are there any recruitment opportunities for this experiment?

"Affirmative, clinicaltrials.gov confirms that this trial is currently open for recruitment and was first uploaded on October 21st 2021. The study seeks 100 volunteers from one location, with the latest update being made on October 26th 2022."

Answered by AI

How many participants are being treated in this trial?

"Correct. According to clinicaltrials.gov, this study is actively seeking enrolment and was first made public on October 21st 2021. An update occurred just over a year later, with the aim of recruiting 100 patients from 1 site."

Answered by AI

To what extent could usage of Venetoclax be detrimental to patient health?

"The safety of Venetoclax is rated as a 2 on our scale, due to the lack of evidence concerning its efficacy despite some data supporting safety."

Answered by AI

What maladies does Venetoclax typically serve to address?

"Venetoclax is mainly prescribed for metabolic acidosis. Nonetheless, it has been known to alleviate symptoms associated with cancer, allogeneic hematopoietic stem cell transplantation, chronic myelogenous leukemia and thrombocythemia essential."

Answered by AI

Can you identify any other research investigations that have incorporated Venetoclax?

"According to current research, Venetoclax has 668 live trials with 68 of them in Phase 3. Most of these studies are being conducted out of Edmonton, Alberta and there are 12486 aggregate sites offering this clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
2021. "Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04708054.
~22 spots leftby Dec 2024
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