Reduced Intensity Donor Stem Cell Transplant in Treating Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission

Completed · Phase 2

Conditions studied: Adult Acute Lymphoblastic Leukemia in Remission, Childhood Acute Lymphoblastic Leukemia in Remission, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia

In brief

The reason for doing this study is to determine whether a new method of blood stem cell transplant (also known as bone marrow transplant) is able to treat acute lymphocytic leukemia. Blood stem cells are the "seed cells" necessary to make all blood cells. This new method of transplant uses a combination of low dose radiation and chemotherapy that may be less toxic and cause less harm than a conventional transplant. This lower dose transplant is called a "nonmyeloablative transplant". Researchers want to see if using less radiation and less chemotherapy combined with new immune suppressing drugs after the transplant will help a stem cell transplant to work. Researchers hope that this treatment will cure acute lymphocytic leukemia with fewer side effects. Researchers are hoping to see a mixture of recipient and donor blood cells after transplant. This mixture of donor and recipient blood cells is called "mixed chimerism". Researchers hope that donor cells will attack and eliminate the leukemia. This is called the "graft-versus-leukemia" effect. In addition, after the transplant, white blood cells from the donor may be given to enhance or "boost" the graft-versus-leukemia effect, and hopefully remove all remaining cancer cells. This study is being done because at the present time blood stem cell transplantation (or bone marrow transplantation) is the only known curative therapy for acute lymphocytic leukemia. Because of age or underlying health status acute lymphocytic leukemia patients have a higher likelihood of experiencing severe harm from a conventional blood stem cell transplant. Researchers are doing this study to see if this new nonmyeloablative method of low dose radiation and low dose chemotherapy given before transplant and immune suppressive drugs after transplant will help make the transplant safer and also cure acute lymphocytic leukemia

Key facts

Study ID: NCT00031655
Run by: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
People needed: 30
Starts: 2001-09-01
Expected to finish: 2012-11-01
Last updated by the study team: 2012-12-07

Who can join

Age: any, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

ADULT PATIENTS:
Patients 50-75 years old with high risk ALL in first CR (CR1) or ALL in CR >= second CR (CR2)
Patients >= 18 years old and < 50 years old with high risk ALL in CR1 who are not eligible for a conventional allogeneic transplantation based on general medical condition
Patients >= 18 years old and < 50 years old with high risk ALL in CR1 who refuse a conventional allogeneic transplant
Patients >= 18 years old and < 50 years old with ALL in CR >= CR2 who are not eligible for a conventional allogeneic transplantation based on general medical condition
Patients >= 18 years old and < 50 years old with high risk ALL in CR >= CR2 who refuse a conventional allogeneic transplant
CR is defined as < 5% blasts by morphology on a bone marrow aspirate and the absence of peripheral blasts
High risk adult ALL in CR1 includes those patients with one or more of the following:
Age >=30 years
Non T-cell phenotype
Cytogenetic abnormalities including t(9;22), t(4;11), trisomy 8, or monosomy 7
Failure to achieve CR after 4 weeks of induction chemotherapy
PEDIATRIC PATIENTS:
Patients < 18 years old with ALL in high risk CR1 who are not candidates for conventional allogeneic transplantation based on general medical condition
Patients < 18 years old with ALL in CR >= CR2 who are not candidates for conventional allogeneic transplantation based on general medical condition
Patients < 12 years old require approval by the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator prior to enrollment
CR is defined as < 5% blasts by morphology on a bone marrow aspirate and absence of peripheral blasts
High risk pediatric ALL in CR1 includes those patients with one or more of the following:
Cytogenetic abnormalities including:
t(9;22) with a white blood cell (WBC) >= 25,000 at diagnosis or
t(4;11) in patients < 1 year old and >= 10 years old or
Hypodiploidy (< 45 chromosomes)
Failure to achieve CR after 4 weeks of induction chemotherapy
Persistent peripheral blasts after one week of induction chemotherapy
DONOR: FHCRC matching Grade 2.1: Unrelated donors who are prospectively:

You may not qualify if…

Active central nervous system (CNS) disease
Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology
Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
Pregnancy or breastfeeding
Human immunodeficiency virus (HIV) seropositivity
ORGAN DYSFUNCTION, ADULT CRITERIA:
Requiring supplementary continuous oxygen OR diffusing capacity of the lung for carbon monoxide (DLCO) < 40%
Cardiac ejection fraction < 35%
Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bridging fibrosis, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease
Karnofsky performance score < 50
ORGAN DYSFUNCTION, PEDIATRIC CRITERIA:
Lansky play-performance score < 40
Patients with active non-hematologic malignancies (except non-melanoma skin cancers)
Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence

Where it is running

Oregon Health and Sciences University — Portland, Oregon, United States
Veterans Affairs Puget Sound Healthcare System — Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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