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Alkylating agents

Stem Cell Transplantation for Blood Cancers

Phase 2

Recruiting

Led By Margaret MacMillan

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 85 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new stem cell transplantation method for treating blood cancer in children & adults.

Who is the study for?

This trial is for children and adults up to 60 years old with various blood cancers, including leukemia and myelodysplasia. Participants must have confirmed hematological malignancies, be in a specific health condition (Karnofsky performance status ≥ 70% or Lansky play score ≥ 50%), and have adequate organ function. Pregnant individuals, those with active infections or known HIV/Hepatitis B/C, prior transplants, CML blast crisis, or CNS malignancy cannot join.

What is being tested?

The study tests T cell receptor alpha/beta depletion PBSC transplantation using drugs like Fludarabine, Busulfan, Melphalan, Rituximab & Levetiracetam on patients with blood cancers. It's an open-label phase II trial aiming to see how well this treatment works for these conditions.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to stem cell transplant process; chemotherapy-related nausea; fatigue; risk of infection; possible liver damage from drugs like Busulfan; neurological issues from Levetiracetam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 85 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~85 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the rate of GVHD after alpha beta TCR depletion

Secondary study objectives

Graft Failure

Non-relapse mortality (NRM)

Overall survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI RegimenExperimental Treatment2 Interventions

Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.

Group II: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients OnlyExperimental Treatment5 Interventions

Flu/Bu/Mel will the preference for patients with JMML or infants with leukemia.

Group III: Fludarabine (flu), Busulfan (bu), Flu/Bu RegimenExperimental Treatment4 Interventions

Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Busulfan

2008

Completed Phase 4

~1710