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Alkylating agents

IM-TMI + Chemotherapy for AML and MDS

Phase 2

Waitlist Available

Led By Damiano Rondelli, MD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

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

Must have

Age 18-65 years

Patients with AML or MDS meeting specific criteria including relapsed or refractory AML, poor-risk AML in first remission, primary refractory disease, MDS with poor-risk features, and CML with a history of accelerated or blast phase

Must not have

Active viral hepatitis or HIV infection

Karnofsky score <70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding a new kind of radiation to the standard myeloablative fludarabine/ i.v. targeted busulfan conditioning improves outcomes for patients receiving allogeneic hematopoietic stem cell transplant (HSCT).

Who is the study for?

This trial is for adults aged 18-65 with high-risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS), including those with specific genetic mutations, poor response to prior treatments, or severe blood cell shortages. Participants need a compatible stem cell donor and must be in relatively good health without serious heart, liver, lung conditions, active infections like hepatitis or HIV, and not pregnant.

What is being tested?

The study tests adding Intensity Modulated Total Marrow Irradiation (IM-TMI) at a dose of 9 Gy to the standard Fludarabine/Busulfan conditioning before allogeneic hematopoietic stem cell transplant. This Phase II trial aims to see if this combination improves outcomes for patients with high-risk AML/MDS.

What are the potential side effects?

Potential side effects include damage to bone marrow resulting in low blood counts; organ toxicity affecting the heart, lungs, liver; increased risk of infections due to immune suppression; mouth sores from chemotherapy; and complications related to stem cell infusion.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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My leukemia or myelodysplastic syndrome is in a difficult-to-treat stage or has returned after treatment.

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I have a stem cell donor who matches the required HLA criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active viral hepatitis or HIV.

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My health is significantly impaired; I need assistance for self-care.

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I am unable to give my consent for treatment.

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I have had radiation on more than 20% of my bone marrow areas.

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I do not have severe heart, kidney, liver problems or high liver enzymes.

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I have cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Relapse free survival of approximately 30% in high-risk patients conditioned with the Fludarabine/ Busulfan regimen

Secondary study objectives

Overall survival

Relapse free survival

Transplant related mortality rate

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patient TreatmentExperimental Treatment7 Interventions

Patients will receive fludarabine 40 mg/m2 IVBP daily for day -5 (5 days before stem cell infusion) through Day -2, IV busulfan targeting a 4800μM/min/ day from day -5 through day -2, and ATG (Thymoglobulin®) at 0.5 mg/kg IV on day -3, and 2 mg/kg on days -2 and day -1 (Only for recipients of stem cells from unrelated or mismatched donors). In addition to the above conditioning regimen all patients will receive TMI at a dose of 3Gy on days -3, -2 and -1. On day 0, the stem cell product will be infused according to BMT unit policy. Graft versus host disease (GVHD) prophylaxis will consist of administration of tacrolimus and methotrexate. Post-transplant evaluation will be done as per standard care with study data collected at day 30, 60, 90, 180, 365 and 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

ATG

2016

Completed Phase 4

~1070