CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Fludarabine +2 moredrug
Likely dose
Fludarabine 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04191187
NCT04191187Phase 2Completed
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Reduced-Intensity Fludarabine, Melphalan, and Total Body Irradiation Conditioning for Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Dec 9, 2019·Updated Dec 11, 2025

In Brief

A Phase 2 clinical trial evaluating Fludarabine, Melphalan, and 1 other intervention for Acute Myeloid Leukemia and 17 related conditions. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute 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
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 9, 2019
Enrollment StartDec 6, 2019
Primary CompletionFeb 11, 2024
Study CompletionFeb 14, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.6 years ago

Interventions

Fludarabinedrug

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

Melphalandrug

Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight.

Total Body Irradiationradiation

Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)