ClinicalTrialsFinder
RecruitingPhase 2NCT04187105

BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)

BMT-06: Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Cyclophosphamide and Post-Transplant Cyclophosphamide Conditioning for Partially HLA Mismatched Allogeneic Transplantation in Patients With Acute Leukemia and Myelodysplastic Syndrome (MDS)

Sponsor

University of Illinois at Chicago

Enrollment

27 participants

Start Date

Jan 27, 2020

Study Type

INTERVENTIONAL

Conditions

Acute LeukemiaMDS

Summary

This study is being done to see if the addition of a targeted form of radiation to standard conditioning regimen will increase the amount of cancer cells that are killed off in the bone marrow and reduce the chances that your disease may return. This description is called Intensity Modulated Total Marrow Irradiation (IM-TMI).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized form of radiation therapy — called intensity modulated total marrow irradiation (IM-TMI) — as preparation for a bone marrow transplant. The goal is to precisely target the bone marrow and cancer cells while sparing healthy organs, in patients with leukemia or other blood cancers. **You may be eligible if...** - You are 18–75 years old - You have leukemia or another blood cancer and are scheduled for a bone marrow transplant - You have a partially matched (haploidentical) family donor available - You meet organ function requirements for transplant **You may NOT be eligible if...** - You have an active serious infection - You have severe organ dysfunction (heart, lungs, liver, or kidneys) - You are pregnant or breastfeeding - You have had prior total body irradiation 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONConditioning regimen with half-matched (haploidentical) stem cell transplant

Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2

DRUGConditioning regimen with half-matched (haploidentical) stem cell transplant

All patients will receive the following standard conditioning regimen: Fludarabine 30 mg/m2 IVPB daily from Day -6 (6 days before stem cell infusion) through Day -2

DRUGConditioning regimen with half-matched (haploidentical) stem cell transplant

Cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5

DEVICEConditioning regimen with half-matched (haploidentical) stem cell transplant

Total body irradiation 2Gy on Day -1.

OTHERConditioning regimen with half-matched (haploidentical) stem cell transplant

Stem cell infusion on Day 0.

DRUGConditioning regimen with half-matched (haploidentical) stem cell transplant

Mesna 14.5 mg/kg IV starting 30 minutes prior to cyclophosphamide on Days -6 and -5 and continuing for at least 12 hours after end of cyclophosphamide

DRUGConditioning regimen with half-matched (haploidentical) stem cell transplant

Cyclophosphamide 50 mg/kg IV on Days 3 and 4 after transplant at a dose of 50mg/kg per day

DRUGConditioning regimen with half-matched (haploidentical) stem cell transplant

Mesna 10 mg/kg IV every 4 hours for 10 doses starting 1 hour prior to cyclophosphamide on Days 3 and 4

DRUGConditioning regimen with half-matched (haploidentical) stem cell transplant

Tacrolimus 0.03 mg/kg IBW Q24H starting on Day 5

DRUGConditioning regimen with half-matched (haploidentical) stem cell transplant

Mycophenolate mofetil (MMF) 15 mg/kg PO TID (maximum daily dose of 3g/day) starting on Day 5

Locations(1)

University of Illinois Cancer Center

Chicago, Illinois, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04187105

Related Trials

A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

NCT04811560102 locations

Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations

NCT018611061 location

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

NCT041956331 location

Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing

NCT069077971 location

Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

NCT0377985410 locations