TriangleNCT00276159 · REGISTRY CONDITION SEARCH
Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2019-09-04
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
Number of Patients Who Received Steroids
Measure of Immune Activation With Correlative Laboratory Studies
Peak Concentrations of 852A
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Subjects are eligible for the study if they meet all of the following Inclusion Criteria: * Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia. * acute lymphoblastic leukemia (ALL) * acute myeloid leukemia (AML) * non-Hodgkin's lymphoma (NHL) * Hodgkin's lymphoma (HL) * multiple myeloma (MM) * chronic lymphocytic leukemia (CLL) * Performance status - Karnofsky \> 50% for patients \> 10 years of age or Lansky \>50% for patients \< 10 year of age * Normal organ function within 14 days of study entry * If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. A female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy Exclusion Criteria: * Had/have the following prior/concurrent therapy: * Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed) * Investigational drugs/agents within 14 days of first dose of 852A * Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose) * Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes unless best available drug required to treat life-threatening conditions * Radiotherapy within 4 weeks of the first dose of 852A * Hematopoietic cell transplantation 4 weeks of first dose of 852A * Active infection or fever \> 38.5°C within 3 days of first dose of 852A * Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication * History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk * Uncontrolled intercurrent or chronic illness * Active autoimmune disease requiring immunosuppressive therapy within 30 days * Active hepatitis B or C with evidence of ongoing viral replication * Hyperthyroidism * Uncontrolled seizure disorder * Active coagulation disorder not controlled with medication * Pregnant or lactating * Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas adequately treated * Proven active central nervous system (CNS) disease * Human Immunodeficiency Virus (HIV) positive * Congenital long QT syndrome or abnormal baseline QTc interval (\> 450 msec in males and \> 470 msec in females) after Bazett's correction (QTc msec = QT msec / square root of the RR interval in seconds) on screening electrocardiogram (ECG).
- healthy Volunteers
- false
- sex
- ALL
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients receiving at least one dose of 852A.
- intervention Names
- Drug: 852A
- label
- 852A Treatment
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 852A Treatment
- description
- Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
- name
- 852A
- other Names
- Molecule 852A
- S-32865
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 6
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
- time Frame
- Up to Week 12
- secondary Outcomes
- description
- Number of patients who received steroids allowing successful continuation of therapy.
- measure
- Number of Patients Who Received Steroids
- time Frame
- Up to Week 12
- measure
- Measure of Immune Activation With Correlative Laboratory Studies
- time Frame
- Up to Week 12
- description
- Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
- measure
- Peak Concentrations of 852A
- time Frame
- Up to Week 12
Full study description
- brief Summary
- The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.
- detailed Description
- 852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
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- payload
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- end
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- exact text
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- start
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- offset unit
- unicode_code_points
- query cond
- Plasma Cell Neoplasms
- query disease state id
- ds-plasma-cell-neoplasms
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
- source file sha256
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- source json pointer
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- source kind
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- source record id
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- source string sha256
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Preserved source evidence · Not medical advice