Clinical trial · Interventional
Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment
NCT00276159CI-TRIAL-00040397terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Drug was not available.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 852A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 852A Treatment
- description
- Patients receiving at least one dose of 852A.
- interventionNames
- Drug: 852A
Primary outcomes (1)
- measure
- Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
- timeFrame
- Up to Week 12
- 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.
Secondary outcomes (3)
- measure
- Number of Patients Who Received Steroids
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.