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Reduced Intensity Conditioning Transplant Using Haploidentical Donors

NCT02581007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-04-27

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Blood and Marrow Transplant Group of Georgia

    collaborator OTHER

  • Northside Hospital, Inc.

    lead OTHER

Principal Investigators

  • Melhem Solh, MD · Northside Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-26
Primary Completion
2019-11-05
Completion
2020-12-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581007 on ClinicalTrials.gov