CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Fludarabine +3 moredrug
Likely dose
Fludarabine 30mg/m2from 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/NCT02581007
NCT02581007Phase 2Completed
CompareCT.gov

Reduced Intensity Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies

Northside Hospital, Inc.·interventional·Posted Oct 20, 2015·Updated Apr 27, 2023

In Brief

A Phase 2 clinical trial evaluating Fludarabine, Melphalan, and 2 other interventions for Chronic Myelogenous Leukemia and 9 related conditions. Completed, enrolled 25 participants across 1 site.

Detailed Summary

This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The primary objective of the study is to estimate the incidence of graft rejection and acute GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS, chronic GVHD and EFS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Myelofibrosis, CMML, Multiple Myeloma
CountriesUnited States
CollaboratorsBlood and Marrow Transplant Group of Georgia

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 20, 2015
Enrollment StartOct 26, 2015
Primary CompletionNov 5, 2019
Study CompletionDec 28, 2020
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.7 years ago

Interventions

Fludarabinedrug

fludarabine (30mg/m2) given every day starting on Day -6 through Day -2;

Melphalandrug

Cyclophosphamidedrug

cyclophosphamide (50mg/kg) given every day starting on Day 3 through Day 4.

peripheral blood stem cell transplantprocedure