RecruitingPhase 1NCT02333162

Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant

A Phase I Study of Intensity Modulated Total Marrow Irradiation (IMTMI) in Addition to Fludarabine/Melphalan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies


Sponsor

University of Chicago

Enrollment

30 participants

Start Date

Dec 5, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects and the best dose of intensity modulated total marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in treating patients with cancers of the blood (hematologic) that have returned after a period of improvement (relapsed) undergoing a second donor stem cell transplant. IMTMI is a type of radiation therapy to the bone marrow that may be less toxic and may also reduce the chances of cancer to return. Giving fludarabine phosphate, melphalan, and IMTMI before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a second bone marrow (stem cell) transplant combined with targeted full-body radiation (total marrow irradiation) and two chemotherapy drugs — fludarabine and melphalan — for patients whose blood cancer has returned after a first transplant. **You may be eligible if...** - You have been diagnosed with acute myeloid leukemia (AML), high-risk MDS (a bone marrow disorder), or certain other blood cancers - Your cancer relapsed after a first donor stem cell transplant - Your general health score (Karnofsky) is 70 or above - Your heart and lung function are within acceptable ranges - A suitable stem cell donor is available **You may NOT be eligible if...** - Your general health is too poor to tolerate the transplant - Your heart ejection fraction (pumping ability) is below 35% - You have severe lung or kidney disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine Phosphate

Given IV

DRUGMelphalan

Given IV

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMTMI

RADIATIONTotal Marrow Irradiation

Undergo IMTMI

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic PBSCT

PROCEDUREPeripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSCT

PROCEDUREAllogeneic Bone Marrow Transplantation

Undergo allogeneic BMT

DRUGTacrolimus

Given IV or PO

DRUGMycophenolate Mofetil

Given IV or PO

OTHERLaboratory Biomarker Analysis

Correlative studies


Locations(1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

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NCT02333162


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