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


Description

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.PRIMARY OBJECTIVES: I. The determine the maximum

Trial Eligibility

Inclusion Criteria: * Patients with the following diseases: acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS) undergoing second allogeneic (allo)-stem cell transplant (SCT) using the same donor or different donor for disease relapse; patients with other hematologic malignancies, including acute lymphoblastic leukemia (ALL), will be at the discretion of the investigators * Karnofsky performance status of 70 or above * Life expectancy is not severely limited by concomitant illness * Adequate cardiac and pulmonary function; patients with decreased left ventricular ejection fraction (LVEF) =\< 40% or diffusion capacity of carbon monoxide (DLCO) =\< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol * Serum creatinine =\<1.5 mg/dL or creatinine clearance \> 50 ml/min; some patients with minor deviations may be accepted on protocol after discussion with the principal investigator (PI) * Serum bilirubin =\< 2.0 mg/dl; some patients with minor deviations may be accepted on protocol after discussion with the PI * Serum glutamic oxaloacetic transaminase (SGPT) \< 5 x upper limit of normal; some patients with minor deviations may be accepted on protocol after discussion with the PI * No evidence of chronic active hepatitis or cirrhosis * Human immunodeficiency virus (HIV)-negative * Patient is not pregnant * Patient or guardian able to sign informed consent * DONOR: Since these patients already had first allo-SCT; in the majority time, the same matched donor has been used for second allo-SCT; if the patients have multiple donors, alternative matched (8/8 or 10/10) donor could be used for the second allo-SCT; the donor could be matched related donors or matched unrelated donors from registry * DONOR: If more than one potential volunteer unrelated donor is considered suitable, further selection of the most suitable donor will be prioritized as follows or will follow our institutional guideline from our stem cell transplant standard operating procedure (SOP): * Age of donor (18-24 \> 25-34 \> 35-44 \> 45+) * Sex of donor (male \> female, nulliparous female \> parous, multiparous female) * Cytomegalovirus (CMV) status, if recipient is CMV seronegative (CMV- \> CMV+

Study Info

Organization

University of Chicago


Primary Outcome

MTD of conditioning regimen defined as any grade III or higher dose-limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0


Outcome Timeframe Up to 30 days post second allo-SCT

NCTID NCT02333162

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2014-12-05

Completion Date 2028-12-01

Enrollment Target 30

Interventions

DRUG Fludarabine Phosphate

DRUG Melphalan

RADIATION Intensity-Modulated Radiation Therapy

RADIATION Total Marrow Irradiation

PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation

PROCEDURE Peripheral Blood Stem Cell Transplantation

PROCEDURE Allogeneic Bone Marrow Transplantation

DRUG Tacrolimus

DRUG Mycophenolate Mofetil

OTHER Laboratory Biomarker Analysis

Locations Recruiting

University of Chicago Comprehensive Cancer Center

United States, Illinois, Chicago


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