Clinical trial · Interventional
URMC Related Haplo-identical Donor BMT
Haploidentical Donor Hematopoietic Stem Cell Transplantation
NCT02660281CI-TRIAL-00054854HaploOnlycompletedPhase 1ClinicalTrials.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)
This study will be a single-center treatment protocol, designed to validate the process of related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant Unit.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Disease | — | UNRESOLVED | — |
| Immune Deficiencies | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Post-Stem Cell Infusion Cyclophosphamide | Drug | — | UNRESOLVED |
| Post-Stem Cell Infusion Mesna | Drug | — | UNRESOLVED |
| Pre-Stem Cell Infusion Cyclophosphamide | Drug | — | UNRESOLVED |
| Pre-Stem Cell Infusion Mesna | Drug | — | UNRESOLVED |
| Stem Cell Infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- OTHER
- label
- Full Intensity TBI-based Conditioning
- description
- Total Body Irradiation 1200 cGy of 150 cGy over 4 or 5 days, days -5 or -4 to -1 Fludarabine 30 mg/m2/day x 3 days, days -6, -5, -4 Stem Cell Infusion, day 0 Post- Stem Cell Infusion Cyclophosphamide 50 mg/kg/day x 2 days, days +3 and +4 Mesna 50 mg/kg/day x 2 days, days +3 and +4
- interventionNames
- Radiation: Total Body Irradiation 1200 cGy
- Drug: Fludarabine
- Procedure: Stem Cell Infusion
- Drug: Post-Stem Cell Infusion Cyclophosphamide
- Drug: Post-Stem Cell Infusion Mesna
- type
- OTHER
- label
- Full Intensity Chemo-Only Conditioning
- description
- Fludarabine 25 mg/m2/day x 5 days, days -6, -5, -4, -3, -2 Busulfan 130 mg/m2/day x 4 days, days -6, -5, -4, -3 Pre-Stem Cell Infusion Cyclophosphamide 14.5 mg/kg/day x 2 days, days -3 and -2 Pre-Stem Cell Infusion Mesna 14.5 mg/kg/day x 2 days, days -3 and -2 Stem Cell Infusion, day 0 Post-Stem Cell Infusion Cyclophosphamide 50 mg/kg/day x 2 days, days +3 and +4 Post-Stem Cell Infusion Mesna 50 mg/kg/day x 2 days, days +3 and +4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Patient Age: * Pediatric (ages 6 months to 18 years) * Adult (ages 18-75 years) Disease: Congenital and Other Non-malignant Disorders * Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome) * Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital Osteopetrosis, Osteogenesis Imperfecta) * Metabolic disorders (e.g. Hurler's Syndrome) * Hemoglobinopathies (e.g. Sickle Cell Disease, Thalassemia) * Severe aplastic anemia High-Risk Leukemias Acute Myelogenous Leukemia * Refractory to standard induction therapy (more than 1 cycle required to achieve remission) * Recurrent (in CR≥2) * Treatment-related AML or MDS * Evolved from myelodysplastic syndrome * Presence of Flt3 abnormalities * FAB M6 or M7 * Adverse cytogenetics Myelodysplastic Syndrome Acute Lymphoblastic Leukemia including T lymphoblastic leukemia * Refractory to standard induction therapy (time to CR \>4 weeks) * Recurrent (in CR ≥2) * WBC count \>30,000/mcL at diagnosis * Age \>30 at diagnosis * Adverse cytogenetics, such as (t(9:22), t(1:19), t(4:11), other MLL rearrangements. Chronic Myelogenous Leukemia in accelerated phase or blast crisis Biphenotypic or undifferentiated leukemia Burkitt's leukemia or lymphoma Lymphoma: * Large cell, Mantle cell, Hodgkin lymphoma refractory or recurrent, chemosensitive, and ineligible for an autologous stem cell transplant or previously treated with autologous SCT * Marginal zone or follicular lymphoma that is progressive after at least two prior therapies Multiple Myeloma, recurrent following high-dose therapy and autologous SCT or ineligible for an autologous HSCT Solid tumors, with efficacy of allogeneic HSCT demonstrated for the specific disease and disease status Graft failure following prior related donor, unrelated donor or UCB transplant Myelofibrosis Exclusion Criteria: 1. Patient Age below 6 months or over 75 years 2. Availability of a 10/10 HLA-matched related or unrelated donor within a reasonable time-frame dictated by the clinical urgency of the transplant 3. Autologous HSCT \< 6 months prior to proposed haplo-SCT 4. Pregnant or breast-feeding 5. Current uncontrolled infection 6. Evidence of HIV infection or positive HIV serology 7. Anti-donor HLA antibodies with positive crossmatch and unsuccessful -
References
Publications (0)
Data not yet available
No reference posted for this study.