Chronic Lymphocytic LeukemiaPhase 2NCT00286780
Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia
A Phase 2 study testing AT-101 in people with Chronic Lymphocytic Leukemia, run by Ascenta Therapeutics at 1 site in United States.
Trial summary
This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- AT-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2007
- 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
- Diagnosis of CLL as defined by the NCI-working group
- Previous treatment with standard systemic chemotherapy or immunotherapy.
- Disease progression or relapse after treatment.
- Indication for treatment as defined by the NCI Working Group Guidelines (Cheson, 1996)
- ECOG performance status ≤ 2
- Adequate liver and renal and bone marrow function
Who cannot join
- Treatment of CLL with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
- Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
- Active secondary malignancy or history of other malignancy within the last five years
- Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis (A, B or C).
- Patients who are contraindicated for treatment with rituximab
- Diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-Hodgkin's lymphoma, or other non-B-CLL B-cell malignancy;
- T-CLL or other T-cell malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moores Cancer Center
San Diego, California, 92093
About this study
Official title: A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia
This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- AT-101
- Keywords
- AT101, AT-101, cancer, lymphoctic, lukemia, Rituximab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-101Drug
80 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AT-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of AT-101 in combination with rituximab
Measured: 5 months for each patient; 20 months entire study
Secondary outcomes (1)
Preliminary efficacy of AT-101 in combination with rituximab
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionNov 2007
- Study completionNov 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascenta Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Kipps, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286780
- Sponsor's protocol ID
- AT-101-CS-008
- Status last verified
- Aug 2010
- First submitted
- 3 Feb 2006
- Last updated
- 13 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00286780
- Acronym / sponsor ID
- AT-101-CS-008
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- AT101, AT-101, cancer, lymphoctic, lukemia, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ascenta TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 6 Feb 2006 (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 is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AT-101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of CLL as defined by the NCI-working group
- Previous treatment with standard systemic chemotherapy or immunotherapy.
- Disease progression or relapse after treatment.
- Indication for treatment as defined by the NCI Working Group Guidelines (Cheson, 1996)
- ECOG performance status ≤ 2
Key exclusion criteria (8 listed)
- Treatment of CLL with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
- Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
- Active secondary malignancy or history of other malignancy within the last five years
- Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis (A, B or C).
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 |
|---|---|---|
| AT-10180 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks | Drug | 1 |
Primary outcome
Safety of AT-101 in combination with rituximab
Time frame: 5 months for each patient; 20 months entire study
1 secondary outcome
Preliminary efficacy of AT-101 in combination with rituximab
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2010.
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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.
Thomas Kipps, MD, PhD principal investigator
University of California, San Diego
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 AT-101 in people with Chronic Lymphocytic Leukemia, run by Ascenta Therapeutics 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 8 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: finished, as of the sponsor's last update on 13 Aug 2010. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of AT-101 in combination with rituximab (time frame: 5 months for each patient; 20 months entire study). 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 Aug 2010.