Search / Trial NCT00001748

HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Dec 9, 2002

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Cyclophosphamide Donor Apheresis Graft Vs. Host Disease Graft Versus Leukemia Leukemic Relapse Myeloma Peripheral Blood Stem Cells Whole Body Irradiation Acute Lymphoblastic Leukemia (All) Chronic Lymphocytic Leukemia (Cll) Chronic Myelogenous Leukemia (Cml) Hematological Malignancies Myelodysplastic Syndrome Myeloproliferative Disorders

Description

Many patients with hematological malignancies potentially curable by bone marrow transplantation are not considered for transplantation because an HLA identical family or unrelated donor is unavailable. For these patients the only curative option is a transplant from a partially matched family donor. Such transplants are feasible but are less successful than matched sibling donor transplants. The main problems with mismatched transplants are graft rejection, graft-vs-host disease, and regimen-related mortality. This restricts the use of mismatched transplants to patients less than 45 years ...

Gender

All

Eligibility criteria

  • Patient:
  • Ages 10-45 years.
  • Chronic myelogenous leukemia, any of these categories: accelerated phase or blast transformation.
  • Acute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in any remission with high-risk features (presenting leukocyte count greater than 100,000/cu mm, Karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia). All second remissions, primary induction failure including partial remission, partially responding or untreated relapse.
  • Acute myelogenous leukemia (AML): All AML in second or subsequent remission, primary induction failure or partial remission and resistant relapse.
  • Myelodysplastic syndromes, any of these categories: refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia.
  • Myeloproliferative disorders undergoing transformation to terminal stages.
  • Chronic lymphocytic leukemia (CLL) in Richter transformation.
  • High-grade lymphoma, refractory to standard treatment approaches, mantle cell lymphoma.
  • No major organ dysfunction precluding transplantation.
  • DLCO greater than 65% predicted.
  • Left ventricular ejection fraction: greater than 40% predicted.
  • ECOG performance status of 0 or 1.
  • Informed consent given. Informed consent from parents for minors.
  • Women of childbearing age with a negative pregnancy test may participate.
  • Donor:
  • Partially HLA matched family donor (3-5/6 matches).
  • Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, and no history of stroke).
  • Informed consent given.
  • Patients or donors must not be pregnant or nursing.
  • Must not have ECOG performance status of 2 or more.
  • No severe psychiatric illness in patient or donor: Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible.
  • No major anticipated illness or organ failure incompatible with survival from BMT.
  • DLCO must not be less than 65% predicted.
  • No left ventricular ejection fraction: less than 40% predicted.
  • Must not have serum creatinine greater than 3 mg/dl.
  • Must not have serum bilirubin greater than 4 mg/dl, Transaminases greater than 3 times the upper limit of normal.
  • Donor or patient must not be HIV positive.
  • Must not have history of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up.
  • Donor must be fit to receive G-CSF and undergo apheresis.
  • Must not fail to mobilize adequate numbers of CD34+ cells after two cycles of G-CSF.

Attachments

readout_NCT00001748_2024-07-23.pdf

4.5 MB

NCT00001748_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

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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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