Donor Hematopoietic Stem Cell Transplant Using High-Dose Fludarabine Phosphate and Total Body Radiation Therapy in Treating Older Patients with Acute Lymphoblastic Leukemia in Complete Remission

Status: complete

This phase II trial studies how well a donor hematopoietic stem cell transplant using high-dose fludarabine phosphate and total body irradiation works in treating older patients with acute lymphoblastic leukemia that has had all signs of cancer disappear in response to treatment (complete remission). Giving high-doses of chemotherapy (myeloablative chemotherapy), such as fludarabine phosphate, and total-body irradiation before a donor hematopoietic stem cell transplant helps to stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving tacrolimus, methotrexate, leucovorin calcium, anti-thymocyte globulin, and/or mycophenolate mofetil after the transplant may stop this from happening. A donor hematopoietic stem cell transplant using high-dose fludarabine phosphate and total body irradiation may be a better treatment for older patients with acute lymphoblastic leukemia.

Inclusion Criteria

Disease Criteria: * ALL in complete remission (CR) at the time of transplant; remission is defined as “less than 5.0% bone marrow lymphoblasts by morphology,” as determined by a bone marrow aspirate obtained within 2 weeks of study registration * Philadelphia chromosome positive ALL is allowed * Lymphoid blastic crisis of chronic myelogenous leukemia (CML) will be included (provided that patients achieve CR)
If younger than 40, there must be comorbidities which preclude the patient to undergo cyclophosphamide (Cy) TBI conditioning regimen
All organ function testing should be done within 28 days of study registration
Left ventricular ejection fraction (LVEF) >= 50% by MUGA (multi gated acquisition) scan or echocardiogram
FEV1 (forced expiratory volume in 1 second) >= 50% predicted
FVC (forced vital capacity) >= 50% predicted
DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) >= 50% of predicted
The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m^2 as calculated by the Cockcroft-Gault Formula
Serum bilirubin =< 2.0 g/dL
Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 upper limit of normal (ULN)
Alkaline phosphatase =< 2.5 ULN
Karnofsky >= 70%
Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the study
Presence of a willing adult human leukocyte antigen (HLA)-matched sibling (excluding identical twin) or HLA-matched unrelated donor meeting all the criteria for routine allo HSCT; all donors will be evaluated for eligibility and suitability per the standard of care according to the Foundation for the Accreditation of Cellular Therapy (FACT) and National Marrow Donor Program (NMDP) guidelines

Exclusion Criteria

Non-compliant to medications
No appropriate caregivers identified
HIV1 (human immunodeficiency virus-1) or HIV2 positive
Active life-threatening cancer requiring treatment other than ALL
Uncontrolled medical or psychiatric disorders
Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest computed tomography (CT) scan within 14 days of registration
Active central nervous system (CNS) leukemia
Preceding allogeneic hematopoietic stem cell transplant (HSCT)
Receiving intensive chemotherapy within 21 days of registration; maintenance type of chemotherapy will be allowed

PRIMARY OBJECTIVES:

I. To establish the efficacy of allogeneic (allo) hematopoietic stem cell transplantation (HCT) in older acute lymphoblastic leukemia (ALL) patients using myeloablative fludarabine phosphate (Flu) total body irradiation (TBI) conditioning regimen.

SECONDARY OBJECTIVES:

I. To assess the safety and toxicity of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen.

OUTLINE:

CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -7 to -4 and undergo 6 fractions of TBI over days -3 to -1.

TRANSPLANT: Patients undergo peripheral blood or bone marrow myeloablative allogeneic HCT on day 0.

GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive tacrolimus IV or orally (PO) on days -3 to 180 followed by taper in the absence of active GVHD and methotrexate IV on days 1, 3, 6, and 11. Patients may receive optional leucovorin calcium IV every 6 hours for 4 doses on days 2, 4, 7, and 12 if severe mucositis occurs. Patients with matched unrelated donors also receive anti-thymocyte globulin IV on days -7 to -5. Patients that are deemed high risk may receive mycophenolate mofetil at the discretion of the transplant physician.

After completion of study treatment, patients are followed up periodically for at least 2 years.

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Donor Hematopoietic Stem Cell Transplant Using High-Dose Fludarabine Phosphate and Total Body Radiation Therapy in Treating Older Patients with Acute Lymphoblastic Leukemia in Complete Remission

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