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

NCT04187105 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-04-06

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Rondelli Damiano, MD · University of Illinois at Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-27
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04187105 on ClinicalTrials.gov