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Bone Marrow Transplant

Nonmyeloablative HCT for Hematologic Malignancies using Related, HLA-Haploidentical Donors (FHCRC-2372)
Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients with Hematologic Malignancies using Related, HLA-Haploidentical Donors: A Phase II trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source
Status Conditions Phase Study ID
Recruiting Hematologic Malignancies Phase II FHCRC-2372
NCT01028716
Summary

RATIONALE: Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GvHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (Fludarabine and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in therapy of the patient's disease than using bone marrow.

PURPOSE: This phase II trial is studying how well donor peripheral blood stem cell transplant works in treating patients with hematologic malignancies.


Investigator
Paul O'Donnell, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Molecular based HLA typing will be performed for the HLA-A, -B, -Cw, -DRB1 and -DQB1 loci to the resolution adequate to establish haplo-identity; a minimum match of 5/10 is required
  • An unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant; clinical urgency is defined as 6-8 weeks from referral or low-likelihood of finding a matched, unrelated donor
  • Acute leukemias (includes T lymphoblastic lymphoma) in remission
  • Remission is defined as < 5% blasts with no morphological characteristics of acute leukemia (e.g., Auer Rods) in a bone marrow with > 20% cellularity, peripheral blood counts showing ANC > 1000/ul, including patients in CRp
  • Acute Lymphoblastic Leukemia in high risk CR1 as defined by at least one of the following: adverse cytogenetics such as t(9;22), t(1;19), t(4;11), MLL rearrangements; white blood cell counts > 30,000/mcL; patients over 30 years of age; time to complete remission > 4 weeks; presence of extramedullary disease
  • OR adverse cytogenetics for overall survival such: those associated with MDS; Complex karyotype (>= 3 abnormalities); or Any of the following: inv(3) or t(3;3), t(6;9), t(6;11), + 8 [alone or with other abnormalities except for t(8;21), t(9;11), inv(16) or t(16;16)], t(11;19)(q23;p13.1)
  • Acute Myelogenous Leukemia in high risk CR1 as defined by at least one of the following: Greater than 1 cycle of induction therapy required to achieve remission; Preceding myelodysplastic syndrome (MDS); Presence of Flt3 abnormalities; or FAB M6 or M7 leukemia;
  • Acute Leukemias in 2nd or subsequent remission
  • Biphenotypic/Undifferentiated Leukemias in 1st or subsequent CR
  • High-risk MDS status-post cytotoxic chemotherapy
  • Burkitt's lymphoma: second or subsequent CR
  • Chemotherapy-sensitive (complete or partial response) large cell, Mantle Cell or Hodgkin's lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are ineligible for an autologous transplant
  • Marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least two prior therapies (excluding single agent Rituxan)
  • Patients with adequate physical function as measured by:
  • Cardiac: left ventricular ejection fraction at rest must be >= 35%
  • Hepatic: bilirubin =< 2.5 mg/dL
  • ALT < 5 x ULN
  • AST < 5 x ULN
  • Alkaline phosphatase < 5 x ULN
  • Renal: serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or GFR) > 40 mL/min/1.73m^2
  • Pulmonary: FEV1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation > 92% on room air
  • Performance status: Karnofsky/Lansky score >= 60%
  • Patients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active GVHD requiring immunosuppressive therapy
  • DONOR INCLUSION CRITERIA: Donors must be HLA-haploidentical first-degree relatives of the patient; eligible donors include biological parents, siblings, or children, or half-siblings
Last Updated
June 02, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.