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Anti-metabolites

Intensity Modulated Total Marrow Irradiation + Fludarabine Phosphate + Melphalan for Hematologic Cancers

Phase 1

Recruiting

Led By Hongtao Liu

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status of 70 or above

No evidence of chronic active hepatitis or cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing IMTMI to see if it's less toxic and more effective than other types of radiation therapy when given with fludarabine and melphalan to patients with relapsed blood cancer before a stem cell transplant.

Who is the study for?

This trial is for patients with relapsed blood cancers like AML or high-risk MDS, who are undergoing a second stem cell transplant. They should have good kidney and liver function, not be pregnant, HIV-negative, and have a Karnofsky performance status of 70+. The donor can be the same as the first transplant or a different matched donor.

What is being tested?

The trial tests intensity modulated total marrow irradiation (IMTMI) combined with fludarabine phosphate and melphalan before a second stem cell transplant. It aims to see how well this approach works in stopping cancer growth and preventing immune rejection of the new stem cells.

What are the potential side effects?

Potential side effects include damage to normal bone marrow cells leading to low blood counts, increased risk of infections due to immune system suppression, organ inflammation from radiation therapy, nausea from chemotherapy drugs, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself but cannot carry on normal activity or do active work.

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I do not have chronic hepatitis or cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Treatment (IMTMI, combination chemotherapy, PBSCT or BMT)Experimental Treatment10 Interventions

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes daily on days -7 to -3 and melphalan IV on day -2. Patients also undergo IMTMI BID for 2 to 5 days between days -7 to -3. TRANSPLANT: Patients undergo allogeneic PBSCT or BMT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO BID on days -2 to 180 with taper thereafter and mycophenolate mofetil IV every 8 hours or PO on days 0-28 (for matched donors) or days 0-40 (for alternative donors) with taper to day 60.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Bone Marrow Transplantation

2009

Completed Phase 2

~530

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330