Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Stem Cell Transplantation and T-Cell Add-Back to Treat Bone Marrow Malignancies

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Hematologic Malignancies

Bone Marrow Transplant Rejection

Eligibility:

All Genders

2-80 years

Phase:

PHASE2

Brief Summary

This study will evaluate the safety and effectiveness of stem cell transplantation in which the donor's T cells (a type of lymphocyte, or white blood cell) are removed and then added back. Certain pat...

Detailed Description

Bone marrow stem cell transplant studies carried out by the National Heart Lung \& Blood Institute (NHLBI) Bone Marrow Transplantation (BMT) Unit have focused on approaches to optimize the stem cell a...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • RECIPIENT:
  • 1\. Ages 10-55 years inclusive (but less than 56)
  • 2\. Chronic myelogenous leukemia (CML) in chronic phase
  • 3\. Acute lymphoblastic leukemia (ALL) categories
  • Adults in first remission with high-risk features
  • All second or subsequent remissions, primary induction failure, partially responding or untreated relapse
  • 4\. Acute myelogenous leukemia (AML)
  • AML in first remission Except AML with good risk karyotypes
  • All AML in second or subsequent remission, primary induction failure and resistant relapse
  • 5\. Myelodysplastic syndromes categories
  • refractory anemia with transfusion dependence
  • refractory anemia with excess of blasts
  • transformation to acute leukemia, chronic myelomonocytic leukemia
  • 6\. Myeloproliferative disorders in transformation to acute leukemia
  • 7\. Chronic lymphocytic leukemia refractory to fludarabine treatment and with bulky progressive disease or with thrombocytopenia (less than or equal to 100,000 /micro L) or anemia (less than or equal to 10g/dl) not due to recent chemotherapy
  • 8\. Non-Hodgkin's lymphoma including Mantle cell lymphoma relapsing or refractory to current chemotherapy and monoclonal antibody treatment and unsuitable for autologous stem cell transplantation
  • 9\. No major organ dysfunction precluding transplantation
  • 10\. Diffusion capacity of lung for carbon monoxide (DLCO) greater than or equal to 60% predicted
  • 11\. Left ventricular ejection fraction: greater than or equal to 40%
  • 12\. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
  • 13\. Able to give informed consent
  • 14\. Negative pregnancy test for women of childbearing age
  • INCLUSION CRITERIA:
  • DONOR
  • 1\. Human leukocyte antigen (HLA) 6/6 identical family donor
  • 2\. Weight greater than or equal to 18 kg
  • 3\. Age greater than or equal to 2 or less than or equal to 80 years old
  • 4\. Fit to receive granulocyte colony -stimulating factor(G-CSF) and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke)
  • EXCLUSION CRITERIA:
  • RECIPIENT
  • 1\. Patient pregnant
  • 2\. Age less than 10 years and 56 years or more
  • 3\. Patients with CML in chronic phase who are 41 years or over in whom imatinib mesylate (STI-571)is the treatment of choice
  • 4\. ECOG performance status of 2 or more
  • 5\. Severe psychiatric illness
  • 6\. Major anticipated illness or organ failure incompatible with survival from BMT
  • 7\. DLCO less than 60% predicted
  • 8\. Left ventricular ejection fraction: less than 40%
  • 9\. Serum creatinine greater than 3mg/dl
  • 10\. Serum bilirubin greater than 4 mg/dl
  • 11\. HIV positive 12. Debilitation or age making the risk of intensive myeloablative therapy unacceptable
  • EXCLUSION CRITERIA:
  • DONOR
  • 1\. Pregnant or lactating
  • 2\. Donor unfit to receive G-CSF and undergo apheresis
  • 3\. HIV positive
  • 4\. Weight less than 18 kg
  • 5\. Age less than 2 or greater than 80 years
  • 6\. Severe psychiatric illness

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2011

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00079391

    Start Date

    January 1 2004

    End Date

    September 1 2011

    Last Update

    October 26 2015

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892