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

NCT ID: NCT02046928

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-03-31

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.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; CLL; SLL

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A6

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

Group Type: EXPERIMENTAL

A6

Intervention Type: DRUG

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

Interventions

A6

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ångstrom Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Moores Cancer Center, UCSD

Locations

Moores Cancer Center, UCSD

La Jolla, California, United States

Countries

United States

Other Identifiers

A6-005

Identifier Type: -

Identifier Source: org_study_id