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AlloStim in Relapsed/Refractory Hematological Malignancies
NCT00861965Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2010
- Primary completion
- Mar 2011
- Countries
- 1
- Sponsor
- Mirror Biologics, Inc.
- Modality
- Native Immune Cells
- Drugs
- allostim
- Conditions
- acute myeloid leukemia (AML)acute lymphoblastic leukemia (ALL)chronic myeloid leukemia (CML)non-Hodgkin lymphoma (NHL)chronic lymphocytic leukemia (CLL)
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Overview
Phase 2, open-label, single-arm trial of allostim in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML) and 5 more, sponsored by Mirror Biologics, Inc. Primary endpoints: Safety of administration of an intravenous AlloStim-9 infusion at 7 days and Safety of administration of up to three consecutive daily intravenous AlloStim-8 booster infusions at 90 days. Started Jan 2010; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment
Intravenous infusion of AlloStim (AlloStim-9 priming and AlloStim-8 boosters)
03
Who it enrols
Adult patients with relapsed or refractory hematological malignancies (AML, ALL, CML, NHL, CLL, MM, Hodgkin's) who have exhausted standard therapies or are ineligible for autologous transplant. Patients must have adequate organ function and no active infection or history of allogeneic transplant.
04
Endpoints
Primary
Safety of administration of an intravenous AlloStim-9 infusion
Safety of administration of up to three consecutive daily intravenous AlloStim-8 booster infusions
Secondary
Objective Response Rate
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