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Sponsored by: |
Immunovative Therapies, Ltd. |
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Information provided by: | Immunovative Therapies, Ltd. |
ClinicalTrials.gov Identifier: | NCT00861965 |
This phase I/II clinical investigation is designed to determine the safety and anti-tumor effects of intravenous administration of the experimental immunotherapy drug, called AlloStim. The active ingredient of AlloStim is living, human immune cells that have been differentiated and expanded outside the body. Because AlloStim does not require HLA match, it is being evaluated as an alternative to allogeneic bone marrow/stem cell transplantation.
Condition | Intervention | Phase |
---|---|---|
Advanced or Refractory Hematological Malignancies |
Biological: AlloStim-9 Biological: AlloStim-8 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Polyclonally Activated, Intentionally Mis-Matched, Allogeneic Th1 Memory Cells (AlloStimTM) in Patients With Relapsed or Refractory Hematological Malignancy Without Prior Conditioning |
Estimated Enrollment: | 50 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
AlloStim is being tested to determine if it might elicit the same anti-tumor mechanism that occurs in allogeneic bone marrow/stem cell transplant (BMT) procedures, without the toxicity associated with graft vs. host disease (GVHD). In allogeneic BMT settings, patients are first conditioned to weaken the immune system in order to enable the engraftment of allogeneic donor cells. Patients require a matched-tissue donor in this setting in order to enable engraftment and also to minimize GVHD toxicity. While allogeneic BMT is a potentially curatve therapy, the treatment-related mortality, mostly related to GVHD toxicity, is high. This toxicity limits the clinical utility of this procedure. AlloStim is being tested to determine if it might be a less toxic alternative to allogeneic BMT.
In this protocol, patients are not conditioned with chemotherapy prior to treatment. Therefore, the allogeneic cells in AlloStim are expected to be rejected by the patient's immune system within 24-48 hours of infusion.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed hematological malignancy of 1 of the following types:
Acute Myeloid Leukemia (AML) meeting the following criteria:
Acute Lymphoblastic Leukemia (ALL) meeting the following criteria:
Chronic Myeloid Leukemia (CML)* with an inadequate response to imatinib meeting 1 of the following criteria:
Non-Hodgkin's Lymphoma (NHL) including Mantle Cell Lymphoma (MCL) meeting 1 of the following criteria:
Chronic Lymphocytic Leukemia (CLL) meeting both of the following criteria:
Multiple Myeloma (MM) meeting 1 of the following criteria:
Hodgkin's Disease
EBV driven lymphoproliferative disorders in immunocompetent patients progressing despite standard therapies, including:
EBV+ Hodgkin's Disease
Exclusion Criteria:
Contact: James Richards, RN, CRA | 760-444-9040 | richardj@immunovative.co.il |
Contact: Hoang-Thu Bui, BS, CRC | 760-444-9040 | thu@immunovative.co.il |
United States, California | |
Immunovative Clinical Research, Inc | |
Carlsbad, California, United States, 92010 |
Study Director: | Dr. Michael Har-Noy | Immunovative Therapies, Ltd. |
Principal Investigator: | Christopher Saucedo, MD | Immunotherapy Clinical Associates, PC |
Responsible Party: | Immunovative Therapies, Ltd ( Dr. Michael Har-Noy ) |
Study ID Numbers: | ITL-001-HM |
Study First Received: | March 12, 2009 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00861965 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia Lymphoma Multiple Myeloma |
Leukemia Hematologic Neoplasms Hematologic Diseases |
Lymphoma Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms Neoplasms by Site Hematologic Neoplasms Hematologic Diseases |