Clinical trial · Interventional
Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Phase 1b, Escalating Dose Study of AVL-292, a Bruton's Tyrosine Kinase (Btk) Inhibitor, as Monotherapy in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
NCT01351935CI-TRIAL-00041548completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and tolerability of AVL-292 as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Cell Non-Hodgkin's Lymphoma | B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Waldenstrom Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVL-292 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AVL-292
- interventionNames
- Drug: AVL-292
Primary outcomes (1)
- measure
- Safety, tolerability,and dose limiting toxicities will be determined using AEs,PE,ophthalmologic examinations,clinical laboratory tests,vital signs, ECGs and echocardiograms/MUGA scans.
- timeFrame
- with in the first 28 days after initiation of once daily oral dosing
Secondary outcomes (4)
- measure
- Establish recommended Phase 2 dose, after completing dose escalation in Part 1 and evaluating accumulated safety,PK,and PD data from the dose escalation phase (Part1)
- timeFrame
- Completion of Part 1 dose escalation phase of study
- description
- After completion of observation for dose limiting toxicities in Part 1 of the study, the accumulated safety, PK, and PD data from Part 1 will be evaluated by the investigators and Sponsor to select a preliminary RP2D for administration to additional subjects to be enrolled into 1 of 3 independent and non-randomized diagnosis-specific expansion cohorts in Part 2 of the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women and men ≥18 years of age * Body weight ≥50 kg. * Confirmed diagnosis of B cellNon-Hodgkin Lymphoma(according to World Health Organization \[WHO\] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop) * Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment. * Eastern Cooperative Oncology Group performance status of ≤ 2 and a life expectancy of at least 3 months. * Ability to swallow oral capsules without difficulty * Has recovered from adverse toxic effects of prior therapies * Meet the following clinical laboratory requirements: * Creatinine ≤ 1.5 × upper limit of normal (ULN) * Total bilirubin ≤ 1.5 x ULN * AST and ALT ≤ 3 × ULN * Platelet count ≥ 50,000/µL (non-hodgkin \& Waldenstrom's) * Platelet count ≥ 30,000/µL (chronic lymphocytic leukemia) * Absolute Neutrophil count ≥ 1000/µL Exclusion Criteria: * Prior allogeneic bone marrow transplant * Autologous stem cell transplant within 3 months of screening * Active central nervous system involvement * Subjects with autoimmune hemolytic anemia or immune thrombocytopenia * Prior treatment with a Btk inhibitor * Active uncontrolled infection * History of malabsorption * Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc. * History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months * History of another currently active cancer * History of major surgery within 4 weeks or minor surgery within 1 week * Other medical or psychiatric illness or organ dysfunction * HIV positive * Positive for Hepatitis B surface antigen or Hepatitis C-virus
References
Publications (1)
- BACKGROUNDArnason JE, Brown JR. B cell receptor pathway in chronic lymphocytic leukemia: specific role of CC-292. Immunotargets Ther. 2014 Jan 24;3:29-38. doi: 10.2147/ITT.S37419. eCollection 2014. PMID 27471698