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

• Sponsor: Ångstrom Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02046928
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 24.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; CLL; SLL	Drug: A6	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A6 A6 is administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).	Drug: A6; A6 is self-administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).

Outcome Measures

Primary Outcome Measures

1. 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

1. Safety of A6 [Throughout 6 Cycles (6 months)]

   Nature and frequency of adverse events

2. Determine IWCLL response rate in the Intent-To-Treat Population [Throughout 6 Cycles (6 months)]

3. Determine the response in patients who received all 6 cycles of A6 [6 months]

4. Determine progression-free survival [Throughout 6 Cycles (6 months)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moores Cancer Center, UCSD	La Jolla	California	United States	92093

Sponsors and Collaborators

• Ångstrom Pharmaceuticals

Investigators

• Principal Investigator: Michael Choi, MD, Moores Cancer Center, UCSD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ångstrom Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02046928
• Other Study ID Numbers: A6-005
• First Posted: Jan 28, 2014
• Last Update Posted: Jul 13, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Ångstrom Pharmaceuticals: Leukemia; Lymphoma
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Jul 13, 2016