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TerminatedNCT02046928Updated Jul 13, 2016

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

A Phase 2 interventional study of A6 in Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma and CLL, sponsored by Ångstrom Pharmaceuticals. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by Ångstrom Pharmaceuticals · Phase 2, Interventional, and Treatment

Why this study was terminated
Slow enrollment
Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • CLL
  • SLL

Keywords

  • Leukemia
  • Lymphoma
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

1,648 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 245 are open to participants now.

This study's enrollment of 5 is below the median of 40 across 1,356 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

Ångstrom Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    A6

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

    Drug: A6

Interventions

  • DrugA6

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

06

What researchers measure

Primary outcomes

  1. Overall response rate

    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 outcomes

  1. Safety of A6

    Nature and frequency of adverse events

    Time frame: Throughout 6 Cycles (6 months)

  2. Determine IWCLL response rate in the Intent-To-Treat Population

    Time frame: Throughout 6 Cycles (6 months)

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

    Time frame: 6 months

  4. Determine progression-free survival

    Time frame: Throughout 6 Cycles (6 months)

07

Study locations

1 site
  • Moores Cancer Center, UCSD
    La Jolla, California 92093, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02046928
Lead sponsor
Ångstrom Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 28, 2014
Start date
Feb 2014
Primary completion
Nov 2015
Completion
Mar 2016
Last update
Jul 13, 2016

Study contacts

Michael Choi, MD
principal investigator · Moores Cancer Center, UCSD

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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