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Family-mismatched/Haploidentical Donors Versus Matched Unrelated Donors

NCT01751997 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-04-19

No results posted yet for this study

Summary

This study will compare the clinical outcomes of transplants from family-mismatched/haploidentical donors (FMT) with transplants from 8/8-matched unrelated donor (MUT), which is a current gold standard donors when lacking of HLA-matched-siblings

1. Primary objectives: Overall survival of FMT may be similar to that of MUT
2. Secondary objectives:

i. Comparison of disease-free survival, relapse, non-relapse mortality, immune reconstitution cytomegalovirus infection, and acute or chronic graft-versus-host disease between FMT and MUT.

ii. Investigation of possible biomarkers related with above events after transplantation

Conditions

Interventions

DRUG

Transplants from 8/8-matched Unrelated donors

* Myeloablative conditioning 1. Total body irradiation; 165 cGy, every 12 hours, 8 doses, days -7 to -4 (total 1320 cGy) 2. Cyclophosphamide; 60 mg/kg/day, IV for 30 minutes, days -3 to -2 (total 120 mg/kg) 3. Antithymocyte globulin (ATG); 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg) * Reduced-intensity conditioning; older patients (age \> 55 years) and/or patients with comorbidities 1. Fludarabine; 30 mg/m\^2/day, IV for 1 hour, days -8 to -4 (total 150 mg/m\^2) 2. Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -3 to -2 (total 6.4 mg/kg) 3. Total body irradiation; 200 cGy, every 12 hours 2 doses, days -1 (total 400 cGy) 4. ATG; 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg) * GVHD prophylaxis 1. Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable) 2. Methotrexate; 5 mg/m\^2/day, IV push, days +1, +3, +6, +11

DRUG

Transplants from family-mismatched/haploidentical donors

* Reduced-intensity conditioning 1. Total body irradiation; 200 cGy, every 12 hours, 4 doses, days -9 to -8 (total 800 cGy) 2. Fludarabine; 30 mg/m\^2/day, IV for 1 hour, days -7 to -3 (total 150 mg/m\^2) 3. Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -6 to -5 (total 6.4 mg/kg) 4. ATG; 1.25 mg/kg/day, IV for 6 hours, days -4 to -1 (total 5.0 mg/kg) * GVHD prophylaxis 1. Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable) 2. Methotrexate; 5 mg/m\^2/day, IV push, days +1, +3, +6, +11

Sponsors & Collaborators

  • Byung-Sik Cho

    lead OTHER

Principal Investigators

  • Hee-Je Kim, MD, PhD · Seoul St. Mary's Hematology Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2019-05-21
Completion
2019-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

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 NCT01751997 on ClinicalTrials.gov