Acute LeukemiaPhase 2NCT04187105
BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)
A Phase 2 study testing Conditioning regimen with half-matched (haploidentical) stem cell transplant in people with Acute Leukemia and MDS, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Leukemia, MDS
- What is being tested?
- Conditioning regimen with half-matched (haploidentical) stem cell transplant
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2020to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 29Show fewer
- 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
- Age>35
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
Rondelli Damiano, MD, 312-996-6179, drond@uic.edu
Marisol Vega, MS, 312-355-5035, vegam35@uic.edu
About this study
Official title: 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)
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).
Read the 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
- Being tested
- Conditioning regimen with half-matched (haploidentical) stem cell transplant
- Keywords
- Stem Cell Transplant, Half-matched (haploidentical) stem cell transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioning regimen with half-matched (haploidentical) stem cell transplantRadiation
Also called Total Marrow Irradiation
Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2
Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug
Also called Fludarabine
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 transplantDrug
Also called Cyclophosphamide
Cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5
Conditioning regimen with half-matched (haploidentical) stem cell transplantDevice
Also called Total body irradiation
Total body irradiation 2Gy on Day -1.
Conditioning regimen with half-matched (haploidentical) stem cell transplantOther
Also called Stem cell transplant
Stem cell infusion on Day 0.
Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug
Also called Mesna
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 transplantDrug
Also called Cyclophosphamide
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 transplantDrug
Also called Mesna
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 transplantDrug
Also called Tacrolimus
Tacrolimus 0.03 mg/kg IBW Q24H starting on Day 5
Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug
Also called Mycophenolate mofetil
Mycophenolate mofetil (MMF) 15 mg/kg PO TID (maximum daily dose of 3g/day) starting on Day 5
| Study group | Role | What they receive |
|---|---|---|
| Conditioning regimen with half-matched (haploidentical) stem cell transplant | Other | Not described Receives: Radiation: Conditioning regimen with half-matched (haploidentical) stem cell transplant; Drug: Conditioning regimen with half-matched (haploidentical) stem cell transplant; Device: Conditioning regimen with half-matched (haploidentical) stem cell transplant; Other: Conditioning regimen with half-matched (haploidentical) stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival
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.
Measured: 1 year
Secondary outcomes (9)
The number of patients with greater than or equal to grade 4 non-hematologic toxicities
Evaluate the incidence of greater than or equal to grade 4 non-hematologic toxicities
Measured: 1 year post-stem cell transplant
Engraftment rates
Engraftment rates at Day 30
Measured: 30 days post-stem cell transplant
Rates of incidence of full donor chimerism
Rates of incidence of full donor chimerism at Day 30
Measured: 30 days post-stem cell transplant
The rate of overall survival (OS)
The rate of overall survival (OS)
Measured: 1 year post-stem cell transplant
The rate of event free-survival (EFS)
The rate of event free-survival (EFS)
Measured: 1 year post-stem cell transplant
The rate of Grade II-IV and III-IV acute GVHD and limited/extensive chronic GVHD
The rate of Grade II-IV and III-IV acute GVHD and limited/extensive chronic GVHD
Measured: 1 year post-stem cell transplant
The rate of progression at 1 year post transplant
The rate of progression at 1 year post transplant
Measured: 1 year post-stem cell transplant
The rate of relapse at 1 year post transplant
The rate of relapse at 1 year post transplant
Measured: 1 year post-stem cell transplant
The rate of non-morality (NRM) at 1 year post transplant
The rate of non-morality (NRM) at 1 year post transplant
Measured: 1 year post-stem cell transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start27 Jan 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment to Arm 1
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damiano Rondelli, MD, University of Illinois Chicago
- Investigators
- Rondelli Damiano, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187105
- Sponsor's protocol ID
- 2019-1149
- Status last verified
- Mar 2026
- First submitted
- 11 Nov 2019
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04187105
- Acronym / sponsor ID
- 2019-1149
- Conditions
- Acute Leukemia, MDS
- Keywords
- Stem Cell Transplant, Half-matched (haploidentical) stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment to Arm 1
| Arm | Type | Receives |
|---|---|---|
| Conditioning regimen with half-matched (haploidentical) stem cell transplant | Other | Radiation: Conditioning regimen with half-matched (haploidentical) stem cell transplant, Drug: Conditioning regimen with half-matched (haploidentical) stem cell transplant, Device: Conditioning regimen with half-matched (haploidentical) stem cell transplant, Other: Conditioning regimen with half-matched (haploidentical) stem cell transplant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Patient age 18-75 years
- Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor.
- Eligible diagnoses are listed below. Patient must have one of the following:
- Adequate end-organ function as measured by:
Key exclusion criteria (8 listed)
- Presence of significant co morbidity as shown by:
- Patients unable to sign informed consent
- Patient who have previously received radiation to >20% of bone marrow containing areas (assessed by radiation oncology physician)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: Total Marrow IrradiationExperimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2 | Radiation | Conditioning regimen with half-matched (haploidentical) stem cell transplant |
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: FludarabineAll 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 |
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: CyclophosphamideCyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5 | Drug | Conditioning regimen with half-matched (haploidentical) stem cell transplant |
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: Total body irradiationTotal body irradiation 2Gy on Day -1. | Device | Conditioning regimen with half-matched (haploidentical) stem cell transplant |
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: Stem cell transplantStem cell infusion on Day 0. | Other | Conditioning regimen with half-matched (haploidentical) stem cell transplant |
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: MesnaMesna 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 |
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: CyclophosphamideCyclophosphamide 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 |
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: MesnaMesna 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 |
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: TacrolimusTacrolimus 0.03 mg/kg IBW Q24H starting on Day 5 | Drug | Conditioning regimen with half-matched (haploidentical) stem cell transplant |
| Conditioning regimen with half-matched (haploidentical) stem cell transplantAlso: Mycophenolate mofetilMycophenolate mofetil (MMF) 15 mg/kg PO TID (maximum daily dose of 3g/day) starting on Day 5 | Drug | Conditioning regimen with half-matched (haploidentical) stem cell transplant |
Primary outcome
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.
9 secondary outcomes
The number of patients with greater than or equal to grade 4 non-hematologic toxicities
Time frame: 1 year post-stem cell transplant
Engraftment rates
Time frame: 30 days post-stem cell transplant
Rates of incidence of full donor chimerism
Time frame: 30 days post-stem cell transplant
The rate of overall survival (OS)
Time frame: 1 year post-stem cell transplant
The rate of event free-survival (EFS)
Time frame: 1 year post-stem cell transplant
The rate of Grade II-IV and III-IV acute GVHD and limited/extensive chronic GVHD
Time frame: 1 year post-stem cell transplant
The rate of progression at 1 year post transplant
Time frame: 1 year post-stem cell transplant
The rate of relapse at 1 year post transplant
Time frame: 1 year post-stem cell transplant
The rate of non-morality (NRM) at 1 year post transplant
Time frame: 1 year post-stem cell transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
Related trials for Acute Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rondelli Damiano, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conditioning regimen with half-matched (haploidentical) stem cell transplant in people with Acute Leukemia and MDS, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rondelli Damiano, MD (312-996-6179, drond@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.