NCT04187105

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a single arm phase II clinical trial. The usual conditioning regimen for haploidentical transplant is the use of chemotherapy (fludarabine/cyclophosphamide) before the transplant and further chemotherapy with cyclophosphamide after the transplant. In addition, a small dose of radiation is also given. Patients will receive a standard conditioning regimen with fludarabine, cyclophosphamide and total body irradiation (Flu/Cy/TBI) prior to haploidentical hematopoietic stem cell transplant (HSCT). Graft-versus-host disease prophylaxis will include cyclophosphamide 50 mg/kg on Day +3 and 4 along with tacrolimus and mycophenolate mofetil.

Conditions

• Acute Leukemia
• MDS

Interventions

Type	Name	Description
RADIATION	Conditioning regimen with half-matched (haploidentical) stem cell transplant	Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2
DRUG	Conditioning 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
DRUG	Conditioning regimen with half-matched (haploidentical) stem cell transplant	Cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5
DEVICE	Conditioning regimen with half-matched (haploidentical) stem cell transplant	Total body irradiation 2Gy on Day -1.
OTHER	Conditioning regimen with half-matched (haploidentical) stem cell transplant	Stem cell infusion on Day 0.
DRUG	Conditioning 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
DRUG	Conditioning 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
DRUG	Conditioning 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
DRUG	Conditioning regimen with half-matched (haploidentical) stem cell transplant	Tacrolimus 0.03 mg/kg IBW Q24H starting on Day 5
DRUG	Conditioning 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

Timeline

• Start date: 2020-01-27
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2019-12-05
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study