Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well fludarabine, melphalan, alemtuzumab, and peripheral stem cell transplant work in treating patients with hematologic cancer.


Study summary:

OBJECTIVES: - Evaluate the proportion of patients with lymphohematopoietic malignancies who achieve durable hematopoietic reconstitution after receiving a nonmyeloablative regimen comprising melphalan, fludarabine, and alemtuzumab followed by allogeneic hematopoietic stem cell transplantation. - Determine the incidence and characteristics of peritransplantation morbidity and mortality (e.g., hepatic veno-occlusive disease or infections) in patients treated with this regimen. - Determine the incidence and severity of acute and chronic graft-versus-host disease in these patients treated with this regimen. - Determine the overall and disease-free survival at 1, 3, 6, 12, and 24 months after transplantation in these patients. - Determine the quality of bone marrow and peripheral blood chimerism at 1, 3, 6, 12, and 24 months after transplantation in these patients. - Assess the kinetics of immune reconstitution in patients treated with this regimen. OUTLINE: Patients are stratified according to donor type (HLA-matched related vs HLA-matched unrelated, single HLA-allele disparate related, or unmatched) (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06). Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days -8 to -5, fludarabine IV over 30 minutes on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Allogeneic peripheral blood stem cells or bone marrow is infused on day 0. Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12 hours beginning on day -1 and continuing orally as tolerated until day 100. Patients are followed every 6 weeks for 6 months, every 3 months for 6 months, every 3-6 months for 1 year, and then annually thereafter or as clinically indicated. PROJECTED ACCRUAL: A maximum of 50 patients (25 HLA-matched related and 25 HLA-mismatched related or matched unrelated) will be accrued for this study within 2 years (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06).


Criteria:

INCLUSION CRITERIA: - Disease criteria: This trial is primarily designed for: 1) patients with relapsed or primary refractory non-Hodgkin's lymphoma, 2) chemosensitive relapsed or refractory acute and chronic lymphocytic leukemias, 3) relapsed or primary refractory Hodgkin's Disease, or advanced (Durie-Salmon stage II or III) multiple myeloma, advanced Waldenstrom macroglobulinemia, who, by virtue of advanced age, intensity of prior radiation and/or chemotherapy, history of prior toxicity associated with chemo/radiotherapy or existing organ dysfunction, would be at undue risk of regimen associated mortality if transplanted according to protocols involving myeloablative conditioning regimens. - Patients with aggressive NHL histologies must have chemo/radiosensitive disease, or have non-progressive disease, or have stable disease on therapy, and be ineligible for an autologous HSC transplant because of disease in the marrow. - Patients with chronic myeloid leukemia and high risk forms of acute myelogenous leukemia or myelodysplastic syndromes are also eligible in the absence of an alternative active higher priority allogeneic transplant protocol for which they are eligible. - Age criteria: Patients may be up to 70 years of age. There is no lower age threshold. Patients above the age of 70 may also participate, after evaluation and approval by the BMT Service attendings. - Absence of active or uncontrolled bacterial, viral, or fungal infection that would contraindicate the use of myelosuppressive chemotherapy. - Patients must have a healthy HLA-compatible donor, either a matched or single HLA allele disparate related donor or a similarly compatible unrelated donor recruited through the National Marrow Donor Program. Related donors must be willing to participate as research subjects and be willing to receive G-CSF to mobilize PBPC and undergo leukapheresis to donate PBSC. Unrelated donors identified by the NMDP may elect to donate either PBSC after treatment with G-CSF, or bone marrow. These unrelated donors will provide informed consent and their PBSC or bone marrow donations will be obtained at a qualified donor center participating in the NMDP. - Each patient must be willing to participate as a research subject and must sign an informed consent form after discussion of the nature and risks of the study prior to entering the protocol. Parents or legal guardians of patients who are minors will sign the consent form for these patients after discussion of the nature and risks of the study. EXCLUSION CRITERIA: - Female patients who are pregnant or lactating. - Active or uncontrolled viral (including HIV-1), bacterial or fungal infection. - Severe renal insufficiency (creatinine >2.0 or creatinine clearance < 30mL/minute) - Severe hepatic dysfunction, as defined by: total bilirubin greater than 2.5 mg/dL and AST and ALT >3xnl, unless the liver is involved with disease. - Severe cardiac insufficiency, defined as a resting left ventricular ejection of less than 30% as measured by echocardiography or radionuclide cardiac angiography. Patients on cardiac medications for congestive heart failure are eligible, as long as their LVEF is greater than 30% on medication. - Severe pulmonary insufficiency, as defined by an adjusted diffusing capacity of less than 40% of predicted value. - Karnofsky or Lansky score <40%


NCT ID:

NCT00027560


Primary Contact:

Study Chair
Hugo R. Castro-Malaspina, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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