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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00526292 |
RATIONALE: Giving chemotherapy drugs, such as cytarabine and cyclophosphamide, before a donor natural killer cell infusion helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the natural killer (NK) cells from a donor are infused into the patient they may help kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving cytarabine or cyclophosphamide followed by a donor natural killer cell infusion works in treating patients with relapsed or persistent acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes after a hematopoietic stem cell transplant.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: cyclophosphamide Drug: cytarabine Procedure: natural killer cell therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia Following Allogeneic Hematopoietic Stem Cell Transplant |
Estimated Enrollment: | 30 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive either cytarabine IV on days -6 to -2 or cyclophosphamide IV over 1 hour on days -3 and -2. Patients then receive an infusion of HLA-haploidentical allogeneic natural killer cells on day 0.
After completion of study therapy, patients are followed at days 15, 30, 60, 100, and 200 and at 1 year.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], blastic phase chronic myelogenous leukemia [CML]), or myelodysplastic syndromes (MDS)
Relapsed or persistent disease after prior hematopoietic stem cell transplantation (HSCT)
Patient has undergone prior related or unrelated HLA-compatible (9/10 or 10/10) HSCT within the past year
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 1 month since prior and no concurrent systemic immunosuppressive agents including, but are not limited to, systemic steroids, calcineurin inhibitors, MTOR-inhibitors, budesonide, or anti-thymocyte globulin
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Katherine Hsu, MD, PhD 646-888-2667 |
Principal Investigator: | Katherine Hsu, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Ann Alice Jakubowski, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Katherine Hsu ) |
Study ID Numbers: | CDR0000563220, MSKCC-07035 |
Study First Received: | September 5, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00526292 |
Health Authority: | Unspecified |
recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia blastic phase chronic myelogenous leukemia previously treated myelodysplastic syndromes childhood myelodysplastic syndromes recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia |
childhood chronic myelogenous leukemia relapsing chronic myelogenous leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
Myelodysplastic syndromes Blast Crisis Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Chronic myelogenous leukemia Precancerous Conditions Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Cyclophosphamide Leukemia, Myeloid |
Leukemia, Myeloid, Acute Recurrence Acute lymphoblastic leukemia, adult Leukemia Preleukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Acute myeloid leukemia, adult Congenital Abnormalities Bone Marrow Diseases Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |