Protocol Details

Low Intensity Preparative Regimen Followed by HLA-Matched, Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematologic Malignancies in Older Adults

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	97-H-0202
Sponsoring Institute	National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 55 Max Age: 71
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	Currently Not Provided
Keywords	Peripheral Blood Stem Cells; Engraftment; Fludarabine; Nonmyeloablative; Graft-Versus-Leukemia; Graft vs. Host Disease; Cyclophosphamide; Donor Apheresis; Nonmyeloablative Bone Marrow Transplantation
Recruitment Keyword(s)	Chronic Myelogenous Leukemia (CML); Acute Lymphoblastic Leukemia (ALL); Acute Myelogenous Leukemia (AML); Myelodysplastic Syndromes; Chronic Lymphocytic Leukemia (CLL); Prolymphocytic Leukemia
Condition(s)	Chronic Lymphocytic Leukemia; Graft vs Host Disease; Leukemia; Myelodysplastic Syndrome; Myeloid Leukemia
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	Procedure/Surgery: Blood cell transplantation
Supporting Site	National Heart, Lung, and Blood Institute

Diseases such as leukemia, lymphoma, and multiple myeloma fall into the category of blood cancers. Some of these conditions can now be cured by bone marrow transplantation (BMT). The ability of BMT to cure these conditions has been credited to the use of high doses of chemotherapy, radiation therapy, and the antileukemia effect of the transplant.

Because the effectiveness of BMT relies on the use of high doses of chemotherapy and total body irradiation (TBI), it is a therapy associated with toxic side effects. These side effects are often deadly and have limited BMT for use in patients under the age of 55.

In this study researchers plan to treat older patients between the ages of 55 to 75 years with blood cell transplants taken from donors who are genetically matched relatives of the patient. In order to decrease the toxic side effects associated with the transplant, researchers will not use chemoradiotherapy. Instead they plan to use intensive immunosuppressive therapy and allow the transplanted cells to take effect.

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Eligibility

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).

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Citations:

Stem cell transplantation (SCT) for chronic lymphocytic leukemia (CLL): graft-versus-leukemia (GVL) without acute graft-versus-host disease (GVHD)

Engraftment of allogeneic hematopoietic progenitor cells with purine analog containing chemotherapy

Primary transplantation of allogeneic peripheral blood progenitor cells mobilized by Filgastrim (G-CSF)

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Contacts:

Principal Investigator	Referral Contact	For more information:
A. John Barrett, M.D. National Heart, Lung and Blood Institute (NHLBI) National Institutes of Health Building 10 Room 3-5322 10 Center Drive Bethesda, Maryland 20892 (301) 402-4170 barrettj@nhlbi.nih.gov	A. John Barrett, M.D. National Heart, Lung and Blood Institute (NHLBI) National Institutes of Health Building 10 Room 3-5322 10 Center Drive Bethesda, Maryland 20892 (301) 402-4170 barrettj@nhlbi.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00001637

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