Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL)

Study Overview
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Brief Summary
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This study will assess the efficacy, safety and pharmacodynamic markers of the study drug, A6, in patients with CLL and small lymphocytic lymphoma (SLL).

Detailed Description
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In patients diagnosed with CLL or SLL, study medication will be injected subcutaneously two times a day in an outpatient setting for up to 6 cycles (28 days = 1 cycle) prior to the primary endpoint assessment.

Official Title
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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

Conditions
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CLL, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, SLL

Intervention / Treatment
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* Drug: A6


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A6<br>A6 is administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days). | Drug: A6<br>* A6 is self-administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) Guidelines for response of clinical, hematological, and bone marrow features. | Assessed at Day 28 of Cycle 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of A6 | Nature and frequency of adverse events | Throughout 6 Cycles (6 months) | 
| Determine IWCLL response rate in the Intent-To-Treat Population |  | Throughout 6 Cycles (6 months) | 
| Determine the response in patients who received all 6 cycles of A6 |  | 6 months | 
| Determine progression-free survival |  | Throughout 6 Cycles (6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, Lymphoma