Search / Trial NCT00001623

Bone Marrow Transplant Studies for Safe and Effective Treatment of Leukemia

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

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Peripheral Blood Stem Cells Graft Versus Leukemia Graft Vs. Host Disease Whole Body Irradiation Donor Apheresis Cyclophosphamide Graft Versus Myeloma Leukemic Relapse Multiple Myeloma Acute Myelogenous Leukemia (Aml) Chronic Myelogenous Leukemia (Cml) Acute Lymphoblastic Leukemia (All) Myelodysplastic Syndromes Chronic Lymphocytic Leukemia (Cll)

Description

One of the most effective ways of preventing lethal graft-versus-host disease (GVHD) after allogeneic bone marrow transplantation (BMT) for leukemia is to remove T-lymphocytes from the transplanted marrow. The reduced early mortality from T cell depletion is however offset by an increased risk of leukemic relapse and infection. We have shown that bone marrow transplants for leukemia depleted of T cells by elutriation and followed by delayed add-back of donor T cells reduces GVHD while preserving an immune response to the hematologic malignancy (the so-called graft-versus-leukemia (GVL) or g...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA-PATIENT:
  • Ages 10 to 55 years.
  • Chronic myelogenous leukemia, any of these categories: chronic phase, accelerated phase of blast transformation.
  • Acute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in first remission with high risk features (presenting leukocyte count greater than 100,000 per cu mm, Karyotypes t9;22, t4, t19, t11, biphenotypic leukemia). All second remissions, primary induction failure, partially responding or untreated relapse.
  • Acute myelogenous leukemia (AML): AML in first remission Except AML with good risk karyotypes: AML M3 (t15;17), AML M4Eo (inv 16), AML t(8;21). All AML in second or subsequent remission, primary induction failure and resistant relapse.
  • Myelodysplastic syndromes, any of these categories: refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia.
  • Multiple myeloma following initial disease control with chemotherapy.
  • Chronic lymphocytic leukemia (CLL) and prolymphocytic leukemia, in remission or partial remission following fludarabine treatment. Richter transformation of CLL.
  • No major organ dysfunction precluding transplantation.
  • DLCO greater than 65 percent predicted.
  • Left ventricular ejection fraction: greater than 40 percent predicted.
  • ECOG performance status of 0 or 1.
  • Informed consent given. Informed consent from both parents for minors.
  • Women of childbearing age with a negative pregnancy test may participate.
  • EXCLUSION CRITERIA:
  • Pregnant.
  • Age greater than 55 or less than 10.
  • ECOG performance status of 2 or more.
  • Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
  • Major anticipated illness or organ failure incompatible with survival from BMT.
  • DLCO less than 65% predicted.
  • Left ventricular ejection fraction: less than 40% predicted.
  • Serum creatinine greater than 3 mg/dl.
  • Serum bilirubin greater than 4 mg/dl.
  • Transaminases greater than 3 x upper limit of normal.
  • HIV positive.
  • History of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up (patient).
  • INCLUSION CRITERIA-DONOR:
  • HLA 6/6 or 5/6 matched sibling donor.
  • Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke).
  • Informed consent given.
  • EXCLUSION CRITERIA - DONOR:
  • Pregnant.
  • Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
  • Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of stroke, thrombocytopenia).
  • HIV positive.

Attachments

readout_NCT00001623_2024-03-05.pdf

4.5 MB

NCT00001623_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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