NCT04187105 · University of Illinois at Chicago
BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)
What this study is about
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).
View original scientific description
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).
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
Primary outcome measures
Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival
Time frame: 1 year
To evaluate the number of patients with acute leukemia or MDS who are GVHD-free, relapse free (GRFS) after 1 year of undergoing undergoing a treatment regimen of haploidentical stem cell transplant with conditioning and total marrow irradiation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient age 18-75 years
- Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor.
- Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4/8 if using HLA-A,-B,-DRB1,-Cw, or 5/10 if using HLA-A,-B,-Cw ,-DRB1, and -DQB1, will be considered evidence that the donor and recipient share one HLA haplotype.
- Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included with a maximum of 4/8 or 5/10 mismatches.
- Eligible diagnoses are listed below. Patient must have one of the following:
- Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia).
- Poor-risk AML in first remission:
- AML arising from MDS or a myeloproliferative disorder, or secondary AML
- Poor risk molecular features including but not limited to presence of FLT3 internal tandem duplication mutation.
- Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (\> 3 abnormalities), inv(3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7
- Poor risk ALL in first remission:
- Poor risk cytogenetics: Philadelphia Chromosome, t(4;11), KMT2A translocation, t(8;14), complex karyotype (⩾ 5 chromosomal abnormalities) and low hypodiploidy (30-39 chromosomes)/near triploidy (60-78 chromosomes)
- Philadelphia-like ALL
- Presentation WBC \>30 × 109 for B-ALL or \>100 109 for T-ALL
- Poor MRD clearance, defined as levels \>1 × 10-3 after induction and levels \>5 × 10-4 after early consolidation by flow cytometry
- Myelodysplastic syndromes (MDS) with at least one of the following poor-risk features:
- i. Poor-risk cytogenetics (including but not limited to 7/7q minus or complex cytogenetics)
- ii. IPSS score of INT-2 or greater
- iii. Treatment-related or Secondary MDS
- iv. MDS diagnosed before age 21 years
- v. Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy
- vi. Life-threatening cytopenias, including those generally requiring greater than weekly transfusions
- vii. Poor risk molecular features including but not limited to the presence of BCOR, ASXL1, p53 or RUNX1 mutations
- Mixed lineage and biphenotypic leukemia
- Adequate end-organ function as measured by:
- a. Left ventricular ejection fraction ≥ 40%
- b. Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \< 5 x ULN
- c. FEV1 and FVC \> 50% of predicted
Exclusion criteria
- Presence of significant co morbidity as shown by:
- a. Left ventricular ejection fraction \< 40%
- b. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN
- c. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia
- d. Karnofsky score \<70
- e. History of cirrhosis
- Patients unable to sign informed consent
- Patient who have previously received radiation to \>20% of bone marrow containing areas (assessed by radiation oncology physician)
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2026 · Source of record for eligibility and locations