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Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide

NCT01010217 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2020-03-25

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Cyclophosphamide

50 mg/kg/day intravenous (IV) over 3 hours on Days 3 and 4.

DRUG

Fludarabine

40 mg/m\^2 IV over 1 hour on Days -6, -5, -4, and -3.

DRUG

Melphalan

140 mg/m\^2 IV (or 100 mg/m\^2 with reduced intensity Regimen 2) over 30 minutes on Day -8.

DRUG

Mesna

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.

DRUG

Rituximab

CD20+ lymphoid malignancies: 375 mg/m2 on Day -13 followed by 1000 mg/m2 on Day -6, +1, and +8.

PROCEDURE

Stem Cell Transplantation

Infusion of donor's stem cells by vein on Day 0, may last anywhere from 15 minutes to several hours.

DRUG

Thiotepa

5 mg/kg Regimen 1 (or 5 mg/kg with reduced intensity Regimen 2) IV over 4 hours on Day -7.

DRUG

Tacrolimus

0.015 mg/kg by vein or orally daily starting on Day +5 for 3 months

DRUG

Mycofenolate mofetil

15 mg/kg/dose orally three times a day starting on Day +5 to Day +100 or otherwise indicated

DRUG

G-CSF

5 mcg/kg/day subcutaneously starting Day 7 once a day daily until neutrophil recovery \> 1000/mcl.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Stefan Ciurea, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-05
Primary Completion
2017-10-05
Completion
2017-10-05
FDA Drug
Yes

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 NCT01010217 on ClinicalTrials.gov