The Role of Cyclosporine in Blood Cell Transplants With T-Cell Add-Back for Blood Cancers

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

Keywords

ClinConnect Summary

Bone marrow stem cell transplant studies carried out by the NHLBI BMT Unit have focused on approaches to optimize the stem cell and lymphocyte dose in order to improve transplant survival and increase the graft-vs.-leukemia effect. A CD34 stem cell dose of greater than 3 x 10(6)/kg was found to increase survival and reduce relapse, while a CD3+ lymphocyte dose of less than 1 x 10(5)/kg was associated with a very low incidence of GVHD. Although processing of 2 peripheral blood progenitor cell (PBPC) collections with the CellPro immunoabsorption method (combined CD34-positive selection and CD...

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ALL

Eligibility criteria

• * INCLUSION CRITERIA - Patient:
• • Ages 10-55 years.
• • Chronic myelogenous leukemia, any of these categories: chronic phase, accelerated phase or 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/cu mm, karyotypes t9; 22, t4, t11, biphenotypic leukemia) All second or subsequent 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 transfusion dependence, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia.
• • Myeloproliferative disorders (myelofibrosis, polycythemia vera, essential thrombocythemia) in transformation to acute leukemia.
• • Chronic lymphocytic leukemia refractory to fludarabine treatment and with bulky progressive disease or with thrombocytopenia (less than or equal to 100,000 / mcl) or anemia (less than or equal to 10g/dl) not due to recent chemotherapy.
• • No major organ dysfunction precluding transplantation.
• • DLCO greater than or equal to 60% predicted.
• • Left ventricular ejection fraction: greater than or equal to 40% predicted.
• • ECOG performance status of 0 or 1.
• • For adults: Written informed consent given by adults. For minors: Written informed consent from one parent or guardian. Informed oral consent from minors: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
• • Women of childbearing age with a negative pregnancy test may participate.
• EXCLUSION CRITERIA - Recipient (any of the following):
• • Patient pregnant.
• • Age less than 10 and greater than 55 years.
• • ECOG performance status of 2 or more.
• • Severe psychiatric illness in the patient or donor. Mental deficiency sufficiently severe as to make compliance with the treatment unlikely, and making informed consent impossible.
• • Major anticipated illness or organ failure incompatible with survival from transplant.
• • DLCO less than 60% predicted.
• • Left ventricular ejection fraction: less than 40% predicted.
• • Serum creatinine greater than 3mg/dl.
• • Serum bilirubin greater than 4 mg/dl.
• • Transaminases greater than 3x upper limit of normal.
• • HIV positive (donor or recipient).
• • History of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up.
• • Individuals with diseases listed above as eligible for this protocol, but where debility or age makes the risk of intensive myeloablative therapy unacceptable. These patients will be considered for a non-myeloablative allogeneic transplantation protocol (97-H-0202, 99-H-0050).
• INCLUSION CRITERIA - Donor:
• • HLA 6/6 identical or 5/6 (one antigen mismatched) family donor.
• • Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke).
• • For adults: Written informed consent given by adults. For minors: Written informed consent from one parent or guardian. Informed oral consent from minors: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
• EXCLUSION CRITERIA - Donor (any of the following):
• • Pregnant or lactating.
• • Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
• • HIV positive.