Clinical trial · Interventional
Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)
A Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Myeloablative Fludarabine/Busulfan and Post-Transplant Cyclophosphamide (PTCY) for Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk AML, CML, and MDS
NCT06802315CI-TRIAL-00116099BMT-13recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia Refractory | — | UNRESOLVED | — |
| Acute Myeloid Leukemia, Relapsed, Adult | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myeloid Leukemia - Accelerated Phase | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan (conditioning for ALLO Transplant) | Drug | Busulfan | ALIAS |
| Cyclophosphamide (CTX) | Drug | Cyclophosphamide | ALIAS |
| Fludarabine (Fludara) | Drug | Fludarabine | ALIAS |
| Intensity modulated total marrow irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Regimen
- description
- Days -5 through -2: Fludarabine 40 mg/m2 IVPB daily and Busulfan targeting AUC 4800μM/min daily Day -3 through -1: Intensity modulated total marrow irradiation (9Gy fractionated) Day 0: Infuse peripheral blood mobilized stem cells Days +3 and +4: Cyclophosphamide 50 mg/kg/day Day 5: Mycophenolate mofetil and Tacrolimus (dose adjustment dependent on trough level) Day 30: Follow up Day 60: Follow up Day 90: Follow up Day 180: Follow up 1. year: Follow up 2. year: Follow up
- interventionNames
- Radiation: Intensity modulated total marrow irradiation
- Drug: Cyclophosphamide (CTX)
- Drug: Fludarabine (Fludara)
- Drug: Busulfan (conditioning for ALLO Transplant)
Primary outcomes (1)
- measure
- GVHD-Free Relapse-Free Survival after Stem Cell Transplant
- timeFrame
- 1 Year Post-Stem Cell Transplant
- description
- The 1-year GVHD- free relapse-free survival after HSCT (hematopoietic stem cell transplantation) conditioned with a 9Gy TMI in combination with FluBu4 and PTCY in patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML), Myelodysplastic Syndrome (MDS) at high risk of relapse.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age 18-65 years. * 2\. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as \<5% bone marrow blasts morphologically: * AML arising from MDS, a myeloproliferative disorder, or secondary AML * Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2 * 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. 2c. Primary refractory disease 2d. MDS with at least one of the following poor-risk features: * Poor-risk cytogenetics including 3q abnormalities, 7/7q minus or complex cytogenetics (\>3 abnormalities). * Current or previous INT-2 or high IPSS score. * Treatment-related MDS. * MDS diagnosed before the age of 21 years. * Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy. * Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions. 2e. CML with a history of accelerated or blast phase. Exclusion Criteria: * 1\. Presence of significant co-morbidity as shown by: * 1a. Left ventricular ejection fraction \< 50% * 2b. Creatinine clearance \<30ml/min. * 3c. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN. * 4d. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia. * 5e. Karnofsky score \<70 * 6f. Active viral hepatitis or HIV infection. * 7g. Cirrhosis. * 2\. Pregnancy or breast feeding * 3\. Patients unable to sign informed consent. * 4\. Patients previously received radiation to \>20% of bone marrow-containing areas.
References
Publications (0)
Data not yet available
No reference posted for this study.