Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT00276159|
Recruitment Status : Terminated (Drug was not available.)
First Posted : January 13, 2006
Results First Posted : May 5, 2010
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia||Drug: 852A||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Experimental: 852A Treatment
Patients receiving at least one dose of 852A.
Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
- Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to Week 12 ]Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.
- Number of Patients Who Received Steroids [ Time Frame: Up to Week 12 ]Number of patients who received steroids allowing successful continuation of therapy.
- Measure of Immune Activation With Correlative Laboratory Studies [ Time Frame: Up to Week 12 ]
- Peak Concentrations of 852A [ Time Frame: Up to Week 12 ]Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276159
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Sarah Cooley, MD||Masonic Cancer Center, University of Minnesota|