Clinical trial · Interventional
Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL)
A Phase 2 Trial to Determine the Safety, Tolerability, and Efficacy of A6, a CD44 Binding Peptide, for the Treatment of Patients With Chronic Lymphocytic Leukemia
NCT02046928CI-TRIAL-00022996terminatedPhase 2ClinicalTrials.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): Slow enrollment
Summary
Brief summary (as posted)
This study will assess the efficacy, safety and pharmacodynamic markers of the study drug, A6, in patients with CLL and small lymphocytic lymphoma (SLL).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| SLL | Small Lymphocytic Lymphoma | ALIAS | 0.90 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A6
- description
- A6 is administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).
- interventionNames
- Drug: A6
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Assessed at Day 28 of Cycle 6
- description
- International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) Guidelines for response of clinical, hematological, and bone marrow features.
Secondary outcomes (4)
- measure
- Safety of A6
- timeFrame
- Throughout 6 Cycles (6 months)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of CLL or SLL based on IWCLL Criteria * Measurable or evaluable disease based on IWCLL criteria * Previously untreated patients who have been counseled on approved alternative therapeutic options. Not a candidate for fludarabine/cyclophosphamide/rituximab (FCR) or has preference to not receive chemotherapy. * Eastern Cooperative Oncology Group (ECOG) status of 0-2. * Adequate bone marrow, renal, liver, cardiac and pulmonary function. * Life expectancy of greater than or equal to 6 months. Exclusion Criteria: * Receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose. * Receipt of corticosteroids \> 20 mg/day within 4 weeks prior to1st dose * Major surgery or radiation within 4 weeks prior to 1st dose * Presence of uncontrolled infection requiring systemic therapy * Active second malignancy other than non-melanoma skin cancer * Uncontrolled autoimmune anemia or thrombocytopenia * Receipt of any investigational agent within 4 weeks prior to 1st dose * Pregnant or lactating female * Any severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.
References
Publications (0)
Data not yet available
No reference posted for this study.