Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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)

BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) (NCT04187105) is a Phase 2 interventional studying Acute Leukemia and MDS, sponsored by University of Illinois at Chicago. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Acute Leukemia and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 27 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patient age 18-75 years 2. 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. 3. Eligible diagnoses are listed below. Patient must have one of the following: 1. Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia). 2. 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 3. 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 - Age\>35 - Poor MRD clearance, defined as levels \>1 × 10-3 after induction and levels \>5 × 10-4 after early consolidation by flow cytometry 4. 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Patient age 18-75 years 2. 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. 3. Eligible diagnoses are listed below. Patient must have one of the following: 1. Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia). 2. 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 3. 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 * Age\>35 * Poor MRD clearance, defined as levels \>1 × 10-3 after induction and levels \>5 × 10-4 after early consolidation by flow cytometry 4. 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 5. Mixed lineage and biphenotypic leukemia 4. 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: 1. 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 2. Patients unable to sign informed consent 3. Patient who have previously received radiation to \>20% of bone marrow containing areas (assessed by radiation oncology physician)

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Illinois Cancer Center

Chicago, Illinois, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04187105), the sponsor (University of Illinois at Chicago), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04187105 clinical trial studying?

Who can participate in NCT04187105?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04187105?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04187105. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04187105. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.