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Stem Cell Transplant for Hematologic Diseases

NCT00058825 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-11-07

Study results available
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Summary

Patients are being asked to participate in this study because they have a cancer in their blood, Fanconi's Anemia, or have been unsuccessfully treated for bone marrow failure such as Aplastic Anemia or Paroxysmal Nocturnal Hemoglobinuria. Any of these conditions could benefit from an allogeneic stem cell transplant using a donor that is related to the patient.

Stem cells are created in the bone marrow. They grow into different types of blood cells that the patient needs, including red blood cells, white blood cells, and platelets. In a transplant, the patient's own stem cells are killed and then replaced by stem cells from the donor.

Usually, patients are given very strong doses of chemotherapy prior to receiving a stem cell transplant. However, because of the patient's condition, they have a high risk of experiencing life-threatening treatment-related side-effects. Recently, some doctors have begun to use chemotherapy that does not cause as many side-effects before patients receive a transplant.

This research study adds CAMPATH 1H to a low-dose chemotherapy regimen, followed by an allogeneic stem cell transplantation. We want to see whether adding CAMPATH 1H to the transplant medications helps in treating the disease. We also want to see whether there are fewer life-threatening side-effects from the treatment. CAMPATH 1H is a drug that is still being studied. CAMPATH 1H stays active in the body for a long time after patients receive it, which means it may work longer at preventing graft-versus-host-disease (GvHD) symptoms.

Conditions

Interventions

BIOLOGICAL

Campath 1H

Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.

DRUG

Fludarabine

Day -5 to Day -2: Fludarabine 30 mg/m2.

PROCEDURE

Stem Cell Transplant

Day 0: Donor stem cells infused.

RADIATION

Total Body Irradiation (TBI)

Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.

DRUG

FK506 (Tacrolimus) or Cyclosporine

Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • George Carrum, MD · Baylor College of Medicine; The Methodist Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

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 NCT00058825 on ClinicalTrials.gov