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Acute Myeloid Leukemia (AML)

Adoptive Immunotherapy for Relapsed AML, MDS, or CML (FH 2498)
Phase I/II Study of Adoptive Immunotherapy After Allogeneic HCT With Virus Specific CD8+ T Cells That Have Been Transduced to Express a WT1-specific T Cell Receptor for Patients With High Risk or Relapsed AML, MDS, or CML
Status Conditions Phase Study ID
Recruiting Acute Myeloid Leukemia (AML); Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Leukemia Phase I/II FH 2498
NCT01640301
Summary

This phase I/II trial studies the side effects of laboratory-treated T cells and to see how well they work in treating patients with high-risk relapsed acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelogenous leukemia (CML) previously treated with donor stem cell transplant. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop cancer cells from growing. Placing a gene that has been created in the laboratory into a person's T cells may make the body build an immune response to kill cancer cells.


Investigator
Merav Bar, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Patients must express human leukocyte antigen (HLA)-A0201
  • Patients undergoing matched allogeneic hematopoietic cell transplantation (HCT) for:
  • Acute Myeloid Leukemia (AML) including:
    • AML beyond first remission, therapy-related AML at any stage, primary refractory AML, AML in relapse (before or after HCT), AML with evidence of minimal residual disease (MRD) at time of HCT or after HCT (by multiparameter flow cytometry, cytogenetics, fluorescence in situ hybridization [FISH] or molecular studies); AML at any stage arising in a patient with an antecedent diagnosis of a hematologic disorder including myelodysplastic or myeloproliferative syndrome (e.g. chronic myelomonocytic leukemia, polycythemia vera, essential thrombocytosis, and agnogenic myeloid metaplasia with myelofibrosis)
    • AML at any stage with unfavorable cytogenetic or molecular abnormalities: Monosomal karyotype (presence of two or more distinct autosomal chromosome monosomies or a single autosomal monosomy associated with at least one structural abnormality), del(5q)/-5, -7/del(7q), abn 3q, 9q, 11q, 20q, 21q, 17p, t(6;9), t(9;22), complex karyotype (>= 3 unrelated abnormalities), Inv(3) or t(3;3), t(6;11), +8 sole,+8 with 1 other abnormality other than t(8;21), t(9;11), inv (16), t(16;16), t(11;19), or normal cytogenetics with FLT3-ITD mutation
  • Myelodysplastic syndrome (MDS) including:
    • Intermediate-2 or high risk category patients according to the International Prognostic Scoring System (IPSS > 1.5) or poor risk karyotype defined as abnormalities involving chromosome 7 or complex karyotype (>= 3 unrelated abnormalities)
    • Relapsed disease post HCT
  • Chronic Myeloid Leukemia (CML) including:
    • CML beyond chronic phase
    • Relapsed disease post-HCT
  • Patients must have an HLA-matched donor of hematopoietic stem cells (related or unrelated)
  • Patients must be able to provide blood and bone marrow samples and undergo the procedures required for this protocol
  • Patients must be >= 30kg, as patients with lower weight would be incapable of providing high volume and frequent blood samples for monitoring and analysis
  • Patients must be able to give informed consent; parent or legal representative will be asked to consent for patients younger than 18 year old
  • DONOR: Patient and donor must be HLA-matched and express HLA-A0201
  • DONOR: Donor must be Epstein-Barr virus (EBV) or cytomegalovirus (CMV) seropositive
  • DONOR: Donor must be age 18 or older
  • DONOR: In good general health, with a Karnofsky or Lansky Play Performance score >= 90%
  • DONOR: Able to give informed consent
Exclusions (conditions that would prevent participation in this study)
  • Central nervous system (CNS) tumor refractory to intrathecal chemotherapy and/or cranio-spinal radiation
  • Human immunodeficiency virus (HIV) seropositive
  • Significant medical or psychological conditions that would make the patient unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)
  • Pregnancy or breast-feeding
  • DONOR: Less than 18 years old
  • DONOR: Active infectious hepatitis
  • DONOR: HIV or human T-lymphotropic virus (HTLV) seropositive
  • DONOR: Pregnancy or nursing
  • DONOR: Significant medical conditions (e.g. immunosuppressive therapy) that would make the donor unsuitable T cell donor
  • DONOR: Unable to give informed consent
Last Updated
August 15, 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.