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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02046928

Enrollment

Registered

2014-01-28

Start date

2014-02-28

Completion date

2016-03-31

Last updated

2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, CLL, SLL, Small Lymphocytic Lymphoma

Keywords

Leukemia, Lymphoma

Brief summary

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

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.

Interventions

DRUGA6

A6 is self-administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Safety of A6	Throughout 6 Cycles (6 months)	Nature and frequency of adverse events
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)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026