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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02046928
• Other study ID #: A6-005
• Status: Terminated
• Phase: Phase 2
• First received: January 20, 2014
• Last updated: July 11, 2016
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: Ångstrom Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• CLL
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• SLL
• Small Lymphocytic Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Moores Cancer Center, UCSD	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Ångstrom Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety of A6	Nature and frequency of adverse events	Throughout 6 Cycles (6 months)	Yes
Secondary	Determine IWCLL response rate in the Intent-To-Treat Population		Throughout 6 Cycles (6 months)	No
Secondary	Determine the response in patients who received all 6 cycles of A6		6 months	No
Secondary	Determine progression-free survival		Throughout 6 Cycles (6 months)	No