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Bone Marrow Transplant

Cyclophosphamide for Preventing Graft-Versus-Host Disease (FHCRC-2541)
A Phase II Study to Evaluate the Efficacy of Posttransplant Cyclophosphamide for Prevention of Chronic Graft-versus-Host Disease after Allogeneic Peripheral Blood Stem Cell Transplantation
Status Conditions Phase Study ID
Closed Chronic Graft Versus Host Disease (cGVHD) Phase II FHCRC-2541
NCT01427881
Summary

Purpose This phase II trial studies how well cyclophosphamide works in preventing graft-versus-host disease after donor peripheral blood stem cell transplant in patients with hematological malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem 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. Giving cyclophosphamide after transplant may stop this from happening.


Investigator
Marco Mielcarek, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Acute lymphocytic leukemia (ALL) in first complete remission (CR1) with high risk features defined as evidence of adverse cytogenetics such as t(9;22), t(1;19), t(4;11), or mixed-lineage leukemia (MLL) rearrangements or presence of minimal residual disease
  • Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
  • Greater than 1 cycle of induction therapy required to achieve remission
  • Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML
  • Presence of fms-related tyrosine kinase 3 (Flt3) mutations or internal tandem duplications
  • French-American-British (FAB) M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia
  • Complex karyotype [>= 3 abnormalities], inv(3), t(3;3), t(6;9), t(6;11), t(11;19)(q23;p13.1), + 8 [alone or with other abnormalities except for t(8:21), t(9;11), inv(16)]
  • Acute leukemia in 2nd or greater CR (CR >= 2)
  • Refractory or relapsed AML with =< 10% bone marrow blasts and no circulating blasts or proven extramedullary disease
  • AML transformed from myelodysplastic syndrome (MDS)
  • MDS with following high risk features:
  • Poor cytogenetics (7q- or complex cytogenetics)
  • International Prognostic Scoring System (IPSS) intermediate (INT)-2 or greater
  • Treatment-related MDS
  • Any phase of MDS if patient is < 21 years of age
  • Chronic myelogenous leukemia (CML) beyond 1st chronic phase or resistant to tyrosine kinase inhibitors (adults) or any phase (pediatric < 21 years)
  • Chronic myelomonocytic leukemia
  • Philadelphia-negative myeloproliferative disorder
  • Lymphoma: relapsed chemotherapy-sensitive (complete or partial response) Hodgkin or non-Hodgkin lymphoma
  • Multiple myeloma-stage III
  • The donor or legal representative must be able to understand and give written informed consent
  • DONORS: The donor must be a genotypically HLA-identical sibling, a phenotypically HLA-matched first-degree relative, or an unrelated donor who is molecularly matched with the patient at HLA-A, B, C, DRB1
  • DONORS: Donors must meet the selection criteria for administration of G-CSF and apheresis defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB)
  • DONORS: Donors must be capable of giving informed consent
Exclusions (conditions that would prevent participation in this study)
  • Prior autologous or allogeneic stem cell transplant
  • Performance status > 2 (Eastern Cooperative Oncology Group [ECOG])
  • Uncontrolled infection; the protocol principal investigator (PI) will be final arbiter if there is uncertainty regarding whether a previous infection is under adequate control to allow enrollment in the study
  • Positive serology for human immunodeficiency virus (HIV)-1, 2 or human T cell lymphotropic virus (HTLV)-1, 2
  • Left ventricular ejection fraction < 45%; no uncontrolled arrhythmias or symptomatic cardiac disease
  • Symptomatic pulmonary disease; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) =< 50% of predicted (corrected for hemoglobin)
  • Measured serum creatinine clearance =< 60 mL/min
  • Total serum bilirubin more than twice upper normal limit
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3-fold higher than laboratory upper normal limits
  • Female patient must have negative beta-human chorionic gonadotrophin (beta-HCG) pregnancy test (all women of child bearing-potential must have test performed)
  • DONORS: Potential donors who for psychological, physiological, or medical reasons cannot tolerate administration of G-CSF or apheresis
  • DONORS: Donors who are allergic to filgrastim or Escherichia (E.) coli-derived proteins
  • DONORS: Donor-related risks to recipients
  • DONORS: Positive anti-donor lymphocytotoxic crossmatch
  • DONORS: Donors who are positive for HIV
Last Updated
November 17, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

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.