Recruiting
Phase 2

IM-TMI

Sponsor:

University of Illinois at Chicago

Code:

NCT04187105

Conditions

Acute Leukemia

MDS

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

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

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

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

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

Study Details

Brief 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

Acute Leukemia

MDS

Study ID

NCT04187105

Start date

Jan 27, 2020

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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

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

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

Cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5

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

Total body irradiation 2Gy on Day -1.

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

Stem cell infusion on Day 0.

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

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

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

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

Tacrolimus 0.03 mg/kg IBW Q24H starting on Day 5

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 measure

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

Central Contacts and Locations

Central contacts

Rondelli Damiano, MD

312-996-6179drond@uic.edu

Marisol Vega, MS

312-335-5035vegam35@uic.edu

Locations

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Rondelli Damiano, MD

312-996-6179drond@uic.edu

Marisol Vega, MS

312-355-5035vegam35@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Keywords

  • Stem Cell Transplant
  • Half-matched (haploidentical) stem cell transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-04-06.