Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults

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

Keywords

ClinConnect Summary

Patients with adult leukemias, non-Hodgkin's lymphoma and multiple myeloma, can now be cured by allogeneic bone marrow transplantation (BMT). This curative effect has been ascribed to the use of high dose chemoradiotherapy and the antileukemia effect of the graft.

The assumption that BMT relies on the myeloablative effect of high dose chemotherapy and total body irradiation (TBI), has largely restricted allogeneic bone marrow transplantation in adults to those under the age of 55 years. Toxicity related mortality increases progressively with age and although some transplant centers carry o...

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA - PATIENT:
• • Ages 55-71 years.
• • Chronic myelogenous leukemia (CML): chronic phase.
• • Acute lymphoblastic leukemia (ALL), all patients in complete or partial remission.
• • Acute myelogenous leukemia (AML): AML in first complete or partial remission. Exceptions: AML with good risk karyotypes: AML M3 t(5;17), AML M4Eo (inv. 16), AML t(8;21). All AML in second or subsequent complete remission.
• • Myelodyplastic syndromes: refractory anemia with excess of blasts (less than 10%) or early transformation to acute leukemia or Chronic myelomonocytic leukemia.
• • Chronic lymphocytic leukemia (CLL) with bulky or progressive disease despite prior treatment with chemotherapy which includes purine analogs.
• • Mantle cell lymphoma.
• • Relapsed or progressive non-Hodgkins lymphoma, failing standard treatment approaches and unsuitable for autologous stem cell transplantation.
• • No major organ dysfunction precluding transplantation.
• • DLCO greater than or equal to 40% predicted.
• • Left ventricular ejection fraction: greater than 30% predicted.
• • ECOG performance status of 0-2.
• INCLUSION CRITERIA - DONOR:
• • HLA identical family donor, up to 75 years old.
• • Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke, no history of severe heart disease).
• • Informed consent given.
• EXCLUSION CRITERIA:
• • Patient or donor pregnant or lactating.
• • Patient age less than 55, greater than 71 years.
• • ECOG performance status of 3 or more. Psychiatric disorder or mental deficiency of the patient or the donor 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 40% predicted.
• • Left ventricular ejection fraction less than 30% predicted.
• • Serum creatinine greater than 2.5 mg/dl.
• • Serum bilirubin greater than 4 mg/dl, transaminases greater than 5 times the upper limit of normal.
• • HIV positive (donor or recipient). Donors who are positive for HBV, HCV, or HTLV will be used at the discretion of the investigator.
• • Other malignant diseases liable to relapse or progress within 5 years.
• • Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of heart failure or unstable angina, platelet count less than 90,000/cu mm).

Trial Officials