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

Phase 2

Terminated

• Conditions: CLL; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; SLL
• Interventions: Drug: A6

• Registration Number: NCT02046928
• Lead Sponsor: Ångstrom Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-25
• Study First Posted: 2014-01-28
• Study Start: 2014-02
• Primary Completion: 2015-11
• Status Verified: 2015-12
• Study Completion: 2016-03
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A6	A6	A6 is administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Determine progression-free survival	Throughout 6 Cycles (6 months)
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

Trial Locations

Locations (1)

Moores Cancer Center, UCSD; 🇺🇸 La Jolla, California, United States