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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT04187105
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Leukemia
  • MDS

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — RADIATION
    Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — DRUG
    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
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — DRUG
    Cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — DEVICE
    Total body irradiation 2Gy on Day -1.
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — OTHER
    Stem cell infusion on Day 0.
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — DRUG
    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
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — DRUG
    Cyclophosphamide 50 mg/kg IV on Days 3 and 4 after transplant at a dose of 50mg/kg per day
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — DRUG
    Mesna 10 mg/kg IV every 4 hours for 10 doses starting 1 hour prior to cyclophosphamide on Days 3 and 4
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — DRUG
    Tacrolimus 0.03 mg/kg IBW Q24H starting on Day 5
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant — DRUG
    Mycophenolate mofetil (MMF) 15 mg/kg PO TID (maximum daily dose of 3g/day) starting on Day 5

Study Details

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).

Key Dates

Start date
Jan 27, 2020
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Conditioning regimen with half-matched (haploidentical) stem cell transplant

Primary Outcome Measure

Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612
Rondelli Damiano, MD
[email protected]
312-996-6179
Marisol Vega, MS
[email protected]
312-355-5035

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By research site
University of Illinois Cancer Center· Chicago, IL

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