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

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
A6
Sponsored by
Ångstrom Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Leukemia, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Moores Cancer Center, UCSD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A6

Arm Description

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

Outcomes

Primary Outcome Measures

Overall response rate
International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) Guidelines for response of clinical, hematological, and bone marrow features.

Secondary Outcome Measures

Safety of A6
Nature and frequency of adverse events
Determine IWCLL response rate in the Intent-To-Treat Population
Determine the response in patients who received all 6 cycles of A6
Determine progression-free survival

Full Information

First Posted
January 20, 2014
Last Updated
July 11, 2016
Sponsor
Ångstrom Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02046928
Brief Title
Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL)
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ångstrom Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL, SLL
Keywords
Leukemia, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A6
Arm Type
Experimental
Arm Description
A6 is administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).
Intervention Type
Drug
Intervention Name(s)
A6
Intervention Description
A6 is self-administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).
Primary Outcome Measure Information:
Title
Overall response rate
Description
International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) Guidelines for response of clinical, hematological, and bone marrow features.
Time Frame
Assessed at Day 28 of Cycle 6
Secondary Outcome Measure Information:
Title
Safety of A6
Description
Nature and frequency of adverse events
Time Frame
Throughout 6 Cycles (6 months)
Title
Determine IWCLL response rate in the Intent-To-Treat Population
Time Frame
Throughout 6 Cycles (6 months)
Title
Determine the response in patients who received all 6 cycles of A6
Time Frame
6 months
Title
Determine progression-free survival
Time Frame
Throughout 6 Cycles (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Choi, MD
Organizational Affiliation
Moores Cancer Center, UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moores Cancer Center, UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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