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

NCT02046928 | Terminated Phase 2

• 1 other identifier: A6-005
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; CLL; SLL

Keywords

Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Safety of A6

  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)

Study Arms (1)

A6

EXPERIMENTAL

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

Drug: A6

Interventions

A6 DRUG

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

A6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ångstrom Pharmaceuticals: lead

Study Sites (1)

Moores Cancer Center, UCSD

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Choi, MD

  Moores Cancer Center, UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 28, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2015-12

Locations

US (1)