Trials / Completed
CompletedNCT04191187
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Biphenotypic Acute Leukemia
- Undifferentiated Leukemia
- Prolymphocytic Leukemia
- Myelodysplastic Syndromes
- Chronic Myelogenous Leukemia
- Myeloproliferative Neoplasm
- Relapsed Large Cell Lymphoma
- Mantle Cell Lymphoma
- Hodgkin Lymphoma
- Burkitt Lymphoma
- Relapsed T-Cell Lymphoma
- Relapsed Chronic Lymphocytic Leukemia
- Relapsed Small Lymphocytic Lymphoma
- Relapsed Marginal B-cell Lymphoma
- Relapsed Follicular Lymphoma
- Lymphoplasmacytic Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine | Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 |
| DRUG | Melphalan | Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. |
| RADIATION | Total Body Irradiation | Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy) |
Timeline
- Start date
- 2019-12-06
- Primary completion
- 2024-02-11
- Completion
- 2024-02-14
- First posted
- 2019-12-09
- Last updated
- 2025-12-11
- Results posted
- 2025-03-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04191187. Inclusion in this directory is not an endorsement.