Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01010217
Phase
PHASE2
Status
Completed

Conditions

  • Blood Stem Cell Transplant Failure
  • Hematologic Malignancies
  • Leukemia

Eligibility Criteria

Sex
ALL
Age
N/A - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    50 mg/kg/day intravenous (IV) over 3 hours on Days 3 and 4.
  • Fludarabine — DRUG
    40 mg/m\^2 IV over 1 hour on Days -6, -5, -4, and -3.
  • Melphalan — DRUG
    140 mg/m\^2 IV (or 100 mg/m\^2 with reduced intensity Regimen 2) over 30 minutes on Day -8.
  • Mesna — DRUG
    10 mg/kg IV every 4 hours for a total of 10 doses starting just prior to first dose of Cyclophosphamide on Days 3 and 4.
  • Rituximab — DRUG
    CD20+ lymphoid malignancies: 375 mg/m2 on Day -13 followed by 1000 mg/m2 on Day -6, +1, and +8.
  • Stem Cell Transplantation — PROCEDURE
    Infusion of donor's stem cells by vein on Day 0, may last anywhere from 15 minutes to several hours.
  • Thiotepa — DRUG
    5 mg/kg Regimen 1 (or 5 mg/kg with reduced intensity Regimen 2) IV over 4 hours on Day -7.
  • Tacrolimus — DRUG
    0.015 mg/kg by vein or orally daily starting on Day +5 for 3 months
  • Mycofenolate mofetil — DRUG
    15 mg/kg/dose orally three times a day starting on Day +5 to Day +100 or otherwise indicated
  • G-CSF — DRUG
    5 mcg/kg/day subcutaneously starting Day 7 once a day daily until neutrophil recovery \> 1000/mcl.

Study Details

The goal of this clinical research study is to learn about the safety of giving a stem cell transplant from a tissue-mismatched donor, followed by cyclophosphamide, to patients with certain types of blood disorders or blood cancers. Melphalan, thiotepa, and fludarabine will also be given before the transplant. Researchers will study the health status of these patients at 3 months after the transplant.

Key Dates

Start date
Nov 5, 2009
Status verified
Mar 2020
Primary completion
Oct 5, 2017
Completion
Oct 5, 2017

Study Design

Enrollment
176 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Haploidentical related
    Arm 1 - Stem Cell Transplantation (SCT), Melphalan 140 mg/m\^2 , Thiotepa 5 mg/kg, Fludarabine 40 mg/m\^2 + high-dose post-transplant cyclophosphamide 50 mg/kg/day
  • Experimental: 1 Antigen Mismatch Related or Unrelated
    Arm 2 - SCT, Melphalan, Thiotepa, Fludarabine + high-dose post-transplant cyclophosphamide.
  • Experimental: Matched Unrelated Donor (MUD)
    Arm 3 - SCT, Melphalan, Thiotepa, Fludarabine + high-dose post-transplant cyclophosphamide

Primary Outcome Measure

Number of Participants With Non-relapse Mortality (NRM) [ Time Frame: At 100 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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