NCT00276159 · STUDY IN CONTEXT
Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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 allowing successful continuation of therapy.
Measure of Immune Activation With Correlative Laboratory Studies
Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- trial label
- Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- outcome key
- om-0000
- source section id
- NCT00276159-om-0000
- source outcome index
- 0
- endpoint
- Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
- endpoint definition
- 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.
- time origin
- Up to Week 12
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Includes patients receiving at least 12 doses of 852A study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- outcome key
- om-0001
- source section id
- NCT00276159-om-0001
- source outcome index
- 1
- endpoint
- Number of Patients Who Received Steroids
- endpoint definition
- Number of patients who received steroids allowing successful continuation of therapy.
- time origin
- Up to Week 12
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Includes patients receiving at least 12 doses of 852A study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- outcome key
- om-0002
- source section id
- NCT00276159-om-0002
- source outcome index
- 2
- endpoint
- Measure of Immune Activation With Correlative Laboratory Studies
- endpoint definition
- Measure of Immune Activation With Correlative Laboratory Studies
- time origin
- Up to Week 12
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis not done to sale of agent - unable to perform.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- outcome key
- om-0003
- source section id
- NCT00276159-om-0003
- source outcome index
- 3
- endpoint
- Peak Concentrations of 852A
- endpoint definition
- Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
- time origin
- Up to Week 12
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not able to analysis due to sale of agent - unable to perform.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 852A Treatment
- regimen
- Patients receiving at least 12 doses of 852A.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00276159-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 852A Treatment
- regimen
- Patients receiving at least 12 doses of 852A.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00276159-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- outcome key
- om-0002
- arm key
- OG000
- arm label
- 852A Treatment
- regimen
- Patients receiving at least 12 doses of 852A.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00276159-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- outcome key
- om-0003
- arm key
- OG000
- arm label
- 852A Treatment
- regimen
- Patients receiving at least 12 doses of 852A.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00276159-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia
- nct id
- NCT00276159
- harm key
- EG000
- source section id
- NCT00276159-ae
- event group key
- EG000
- event group label
- 852A Treatment
- serious affected
- 4
- serious at risk
- 6
- other affected
- 4
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Day 1 of Treatment through Week 12
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice
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