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Alkylating agents

High-dose Chemotherapy + Mismatched Allogeneic Stem Cell Transplant for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Scott Solomon, MD

Research Sponsored by Northside Hospital, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will give patients a drug called Venetoclax for 7 days before a stem cell transplant. They will also receive other chemotherapy drugs like Decitabine, Fludarabine

Who is the study for?

This trial is for patients with certain blood disorders like Acute Myeloid Leukemia or Myelodysplastic Syndrome who are eligible for a stem cell transplant from a donor that isn't an exact match. Specific eligibility details aren't provided, but typically participants need to meet health standards and may be excluded based on factors like other illnesses or treatments.Check my eligibility

What is being tested?

The study tests adding Venetoclax to the usual high-dose chemo regimen before a mismatch allogeneic stem cell transplant. Patients will take Venetoclax for 7 days, Decitabine and Fludarabine for 5 days each, Busulfan for 2 days, then undergo total body irradiation followed by the transplant.See study design

What are the potential side effects?

Potential side effects might include nausea, vomiting, diarrhea due to chemotherapy; low blood counts; risk of infection; mouth sores; fatigue; liver problems from Venetoclax; and skin reactions from radiation. Each patient's experience can vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of relapse/progression by conducting blood and bone marrow biopsy evaluations at one-year post-transplant

Secondary outcome measures

Number of patients alive at one-year post transplant

Number of patients alive without recurrence of disease at one-year post transplant by conducting blood and bone marrow biopsy procedures

Number of patients who are alive at one-year post transplant who also did not develop GVHD

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: High-dose Chemotherapy + Mismatched Allogeneic Stem Cell TransplantExperimental Treatment5 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Decitabine

2004

Completed Phase 3

~1680

Busulfan

2008

Completed Phase 3

~1120

Fludarabine

2012

Completed Phase 3

~1100

Total Body Irradiation

2006

Completed Phase 3

~820

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor

24 Previous Clinical Trials

1,068 Total Patients Enrolled

Scott Solomon, MDPrincipal InvestigatorNorthside Hospital/BMTGA

6 Previous Clinical Trials

20,229 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available slots for patients to participate in this research study?

"Information available on clinicaltrials.gov indicates that recruitment for this particular study is presently closed. The trial was initially listed on August 31, 2024 and last amended on March 22, 2024. While this specific trial is not accepting participants currently, it's noteworthy that there are a substantial number of other trials - precisely 1678 - actively seeking candidates at the moment."

Answered by AI

What is the safety profile of high-dose chemotherapy combined with a mismatched allogeneic stem cell transplant for individuals?

"Based on our assessments at Power, the safety rating for High-dose Chemotherapy + Mismatched Allogeneic Stem Cell Transplant stands at 2. This corresponds to a Phase 2 trial level where some safety data is available but no efficacy data has been documented yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant

2024. "Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06337331.