Chronic Lymphocytic LeukemiaPhase 2NCT02046928
Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing A6 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Ångstrom Pharmaceuticals at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL
- What is being tested?
- A6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores Cancer Center, UCSD
La Jolla, California, 92093
About this study
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
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.
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL, SLL
- Being tested
- A6
- Keywords
- Leukemia, Lymphoma
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A6Drug
A6 is self-administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).
| Study group | Role | What they receive |
|---|---|---|
| A6 | Experimental | A6 is administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days). Receives: Drug: A6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) Guidelines for response of clinical, hematological, and bone marrow features.
Measured: Assessed at Day 28 of Cycle 6
Secondary outcomes (4)
Safety of A6
Nature and frequency of adverse events
Measured: Throughout 6 Cycles (6 months)
Determine IWCLL response rate in the Intent-To-Treat Population
Measured: Throughout 6 Cycles (6 months)
Determine the response in patients who received all 6 cycles of A6
Measured: 6 months
Determine progression-free survival
Measured: Throughout 6 Cycles (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2015
- Study completionMar 2016
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ångstrom Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Choi, MD, Principal investigator, Moores Cancer Center, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046928
- Sponsor's protocol ID
- A6-005
- Status last verified
- Dec 2015
- First submitted
- 20 Jan 2014
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02046928
- Acronym / sponsor ID
- A6-005
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL, SLL
- Keywords
- Leukemia, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ångstrom PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A6 | Experimental | Drug: A6A6 is administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A6A6 is self-administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days). | Drug | A6 |
Primary outcome
Overall response rate
Time frame: Assessed at Day 28 of Cycle 6
International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) Guidelines for response of clinical, hematological, and bone marrow features.
4 secondary outcomes
Safety of A6
Time frame: Throughout 6 Cycles (6 months)
Determine IWCLL response rate in the Intent-To-Treat Population
Time frame: Throughout 6 Cycles (6 months)
Determine the response in patients who received all 6 cycles of A6
Time frame: 6 months
Determine progression-free survival
Time frame: Throughout 6 Cycles (6 months)
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Choi, MD principal investigator
Moores Cancer Center, UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A6 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Ångstrom Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Assessed at Day 28 of Cycle 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.