NCT02581007

Reduced Intensity Conditioning Transplant Using Haploidentical Donors

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Northside Hospital, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will receive a haploidentical transpalnt using a fludarabine melphalan prepartive regimen. Patients will get cyclophosphamide on days 3 \& 4 post-transplant.

Conditions

• Chronic Myelogenous Leukemia
• Acute Myelogenous Leukemia
• Myelodysplastic Syndrome
• Acute Lymphocytic Leukemia
• Chronic Lymphocytic Leukemia
• Hodgkin's Lymphoma
• Non-Hodgkin's Lymphoma
• Myelofibrosis
• CMML
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Fludarabine	fludarabine (30mg/m2) given every day starting on Day -6 through Day -2;
DRUG	Melphalan
DRUG	Cyclophosphamide	cyclophosphamide (50mg/kg) given every day starting on Day 3 through Day 4.
PROCEDURE	peripheral blood stem cell transplant

Timeline

• Start date: 2015-10-26
• Primary completion: 2019-11-05
• Completion: 2020-12-28
• First posted: 2015-10-20
• Last updated: 2023-04-27
• Results posted: 2023-04-27

Locations

1 site across 1 country: United States