Clinical trial · Interventional
Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies
Reduced-Intensity Fludarabine, Melphalan, and Total Body Irradiation Conditioning for Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies
- 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 is a single arm, phase II trial of HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using reduced intensity conditioning (fludarabine and melphalan and total body irradiation). Peripheral blood is the donor graft source. This study is designed to estimate disease-free survival (DFS) at 18 months post-transplant.
Conditions
Conditions (18)
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 Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Biphenotypic Acute Leukemia | — | UNRESOLVED | — |
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoplasmacytic Lymphoma | Lymphoplasmacytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Total Body Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Conditioning Regimen + Transplant
- description
- All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT)
- interventionNames
- Drug: Fludarabine
- Drug: Melphalan
- Radiation: Total Body Irradiation
Primary outcomes (1)
- measure
- Disease Free Survival
- timeFrame
- Up to 18 months post-transplant
- description
- Disease Free Survival (DFS) is defined as the time from the date of Peripheral Blood Stem Cell Transplant (PBSCT) to first documentation of relapse or death due to any cause, whichever comes first.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 55 years or HCT Co-Morbidity score (HCT-CI) \>/=3 * Lack of a suitable 8/8 HLA-matched sibling donor * Adequate performance status is defined as Karnofsky score ≥ 70% * Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors must be HLA-haploidentical relatives including, but not limited to, children, siblings, or parents, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1. * Acute Myeloid Leukemia (AML): Must be in remission with morphology (\<5% blasts) * Acute Lymphoblastic Leukemia (ALL)/lymphoma second or greater complete remission (CR) first CR unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities, first CR high-risk ALL * Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR * Myelodysplastic syndrome: any subtype including refractory anemia (RA) if severe pancytopenia or complex cytogenetics. Blasts must be less than 5%. If 5% of more requires chemotherapy for cytoreduction to \</=5% prior to transplantation. * Chronic Myelogenous leukemia in accelerated phase: patient must have failed at least two different Tyrosine Kinase Inhibitor (TKI)s, been intolerant to all TKIs, or have T315l mutation * Myeloproliferative neoplasms/myelofibrosis: Blasts must be less than 5%. If 5% or more requires chemotherapy for cytoreduction to \</=5% prior to transplantation * Relapsed large-cell lymphoma, mantle-cell lymphoma or Hodgkin lymphoma that is chemotherapy sensitive and has failed or ineligible for an autologous transplant * Burkitt's lymphoma in second CR or subsequent CR * Relapsed T-cell lymphoma that is chemotherapy sensitive in CR/Partial Response (PR) that has failed or ineligible for an autologous transplant * Natural killer cell malignancies * Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma with any of the following: * Progressed within 12 months of achieving a partial or complete remission Patients who had remissions lasting up * Patients who had remission lasting \> 12 months are eligible after at least two prior therapies * Patients with primary, refractory disease. Bulky disease and an estimated tumor doubling time of less than one month require debulking therapy prior to transplant. * Lymphoplasmacytic lymphoma is eligible after initial therapy if chemotherapy sensitive * Adequate organ function as defined per protocol * Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use adequate birth control during study treatment Exclusion Criteria: * Pregnant or breastfeeding * Untreated active infection * Active HIV infection * Prior allogenic transplant at any time prior or less than 6 months since prior autologous transplant (if applicable) * Active central nervous system malignancy * Favorable risk AML defined as per protocol * Active central nervous system malignancy * Favorable risk AML defined as having one of the following: * t(8,21) without cKIT mutation or evidence of immunophenotypic, cytogenetic or molecular minimal residual disease (MRD) * inv(16) or t(16;16) without cKIT mutation or evidence of MRD * Normal karyotype with mutated NPM1 but FLT3-ITD wild type without evidence of MRD * Normal karyatype with double mutated CEBPA without evidence of MRD
References
Publications (0)
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