Search / Trial NCT00001144

Modified Bone Marrow Stem Cell Transplantation for Chronic Myelogenous Leukemia

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Nov 3, 1999

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Peripheral Blood Stem Cells Engraftment Graft Vs. Host Disease Graft Versus Leukemia Graft Versus Tumor/Melanoma Chronic Myelogenous Leukemia

Description

CML is a disease which progresses to blast crisis within five years of onset despite medical intervention. Allogeneic transplantation has provided a definitive cure for a large number of patients. The International Bone Marrow transplant registry reports a 67% three-year disease free survival for CML patients receiving a matched sibling transplant. However there remains a 17-20% treatment-related mortality and significant long-term complications. Myeloablative regimens with total body irradiation (TBI) are associated with certain sterility, along with a significant incidence of cataracts an...

Gender

All

Eligibility criteria

  • PATIENTS:
  • Patients in chronic phase CML.
  • Age 10 to 50.
  • Informed consent given.
  • Availability of HLA identical or single HLA-locus mismatched family donor.
  • Females must not be pregnant or lactating.
  • Must not have ECOG performance status of 3 or more. Must not have a psychiatric disorder or mental deficiency severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
  • Must not have major anticipated illness or organ failure incompatible with survival from PBSC transplant.
  • Must not have diffusion capacity of carbon monoxide (DLCO) less than 40% predicted.
  • Must not have left ventricular ejection fraction: less than 30%.
  • Must not have serum creatinine greater than 50% above normal as defined by age.
  • Must not have serum bilirubin greater than 4 mg/dl.
  • Must not have transaminases greater 5 x upper limit of normal.
  • Must not have other malignant diseases liable to relapse or progress within 5 years.
  • DONOR:
  • HLA identical or single HLA-locus mismatched family donor, up to 80 years old.
  • Informed consent given.
  • Females must not be pregnant or lactating.
  • Donor must be fit to receive G-CSF and undergo apheresis. (No controlled hypertension, no history of congestive heart failure or unstable angina, thrombocytopenia).
  • Must be HIV negative. Donors who are positive for hepatitis B (HBV), hepatitis C (HBC) or human T-cell lymphotropic virus (HTLV)-I will be used at the discretion of the investigator.

Attachments

readout_NCT00001144_2024-05-23.pdf

4.5 MB

NCT00001144_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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