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Experimental Bone Marrow Transplant Protocol

NCT00061581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-09-26

No results posted yet for this study

Summary

Bone marrow transplantation (BMT) is a risky procedure. If doctors could reduce the complications, BMT would be safer to use for a wider range of conditions. The purposes of this study are

* to prevent graft rejection by increasing the amount of immunosuppression and by giving some lymphocytes from the donor before transplant;
* to prevent graft-versus-host disease (GVHD) by transplanting T-cell depleted stem cells;
* to improve the immune effect against residual leukemia by the add-back of donor lymphocytes before transplant and six or more weeks after transplant.

Beyond the standard transplant protocol, study participants will undergo additional procedures. First, along with total body irradiation, patients will receive two drugs (a high dose of cyclophosphamide and fludarabine) to suppress immunity and prevent rejection of the transplant. Second, four days before the transplant, patients will be given donor lymphocytes that have been irradiated to make them incapable of causing GVHD. On the day of the transplant, patients will receive an infusion of T-cell depleted bone marrow stem cells. Finally, patients will receive two doses of add-back donor T-cells (45 and 100 days post transplant) and the immunosuppressive drug cyclosporine starting on day 44 until about six months after transplant.

Study participants must be between the ages of 10 and 56 and have a family member who is a suitable stem cell donor match.

Conditions

  • Acute Lymphocytic Leukemia
  • Chronic Myeloid Leukemia
  • Acute Myelocytic Leukemia
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorders

Interventions

DEVICE

Isolex 300i Stem Cell Selection

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • A. John Barrett, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-19
Primary Completion
2007-12-28
Completion
2017-06-14

Countries

  • United States

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 NCT00061581 on ClinicalTrials.gov