MedTrace Logo

NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders

NCT00053989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-02-10

Study results available
· View outcomes & findings →

Summary

RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.

Conditions

Interventions

BIOLOGICAL

anti-thymocyte globulin

iv

BIOLOGICAL

graft-versus-tumor induction therapy

iv

BIOLOGICAL

sargramostim

iv

BIOLOGICAL

therapeutic allogeneic lymphocytes

iv

DRUG

cyclophosphamide

injection

DRUG

fludarabine phosphate

iv

DRUG

methylprednisolone

oral

DRUG

mycophenolate mofetil

oral

DRUG

tacrolimus

oral

PROCEDURE

allogeneic bone marrow transplantation

iv

PROCEDURE

peripheral blood stem cell transplantation

iv

PROCEDURE

umbilical cord blood transplantation

iv

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Philip L. McCarthy, MD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2002-01-29
Primary Completion
2018-07-19
Completion
2018-07-19

Countries

  • United States

Study Locations

More Related Trials

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 NCT00053989 on ClinicalTrials.gov