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

Ångstrom Pharmaceuticals (Industry)
Overall Status
Terminated ID

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
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:
Actual Enrollment :
5 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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


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

Sponsors and Collaborators

  • Ångstrom Pharmaceuticals


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Ångstrom Pharmaceuticals Identifier:
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2016