Follicular LymphomaPhase 2NCT00440388
Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma
A Phase 2 study testing AT-101 and Rituximab in people with Follicular Lymphoma, run by Ascenta Therapeutics at 28 sites in United States.
Trial summary
This is a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- AT-101 and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 23 participants
- Where
- 28 sitesUnited States
- Study dates
- Oct 2006to Nov 2008
- 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
- Histologically confirmed, previously untreated Grade I-II follicular B-cell non-Hodgkin's lymphoma (stage I, II, III and IV). Patients may have received radiation therapy to one lymph node region; Stage I or II patients must have relapsed after prior radiation therapy to be eligible;
- Patients with any FLIPI score may participate. Patients with FLIPI scores 3-5 may be enrolled with asymptomatic disease, or without worsening disease or disease related-symptoms; however patients with FLIPI scores of 0-2 must have evidence of worsening disease;
- ECOG performance status 0-1;
- Measurable disease;
- Adequate hematological function as indicated by:
- Absolute neutrophil count (ANC) >1,000/µL; +Hemoglobin >8 g/dL (It is acceptable to transfuse PRBC to achieve this criterion);
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- Platelet count >50 x 109/L.
- Adequate hepatic and renal function as indicated by:
- Serum creatinine ≤2.0 mg/dL;
- Serum albumin ≥2.5 g/dL;
- Total bilirubin ≤1.5 x upper limit of normal (ULN);
- Serum AST and ALT ≤1.5 x ULN.
- Able to swallow and retain oral medication
Who cannot join
- Patients who have severe lymphoma-related symptoms requiring a rapid response to therapy (e.g., requirement for cytoreduction due to advanced disease or organ compromise, respiratory compromise because of large effusions or airway obstruction, bowel obstruction, ureteral obstruction, and chylous ascites);
- Active symptomatic fungal, bacterial and/or viral infection including, but not limited to active HIV or viral hepatitis (A, B or C);
- History of hepatitis B infection;
- Any B-cell, T-cell or transformed lymphoma other than histologically confirmed follicular non-Hodgkin's lymphoma;
- Central nervous system (CNS) lymphoma, CNS or leptomeningeal involvement by lymphoma (treated or in remission), HIV-related lymphoma, or patients with symptoms suggesting HIV infection;
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
New York Oncology Hematology, P.C.
Albany, New York
Hematology/Oncology Associates
Albuquerque, New Mexico, 87106
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
Cancer Care & Hematology Specialists of Chicagoland
Arlington Heights, Illinois
Rocky Mountain Cancer Center-Aurora
Aurora, Colorado
Texas Oncology, P.A.
Bedford, Texas
University of Alabama at Birmingham
Birmingham, Alabama, 35296
Virginia Oncology Associates
Chesapeake, Virginia
Missouri Cancer Associates
Columbia, Missouri
Texas Cancer Center at Medical City
Dallas, Texas
Duke University Medical Center
Durham, North Carolina, 27707
Central Indiana Cancer Centers
Fishers, Indiana
Texas Oncology, P.A.
Fort Worth, Texas
The Jones Clinic
Germantown, Tennessee, 38138
Comprehensive Cancer Centers of Nevada
Henderson, Nevada
Florida Cancer Institute
Hudson, Florida, 34667
St. Mary's Medical Center
Huntington, West Virginia, 25701
Allison Cancer Center
Midland, Texas
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota
HOAST - New Braunfels
New Braunfels, Texas
Florida Cancer Institute
New Port Richey, Florida, 34655
West Texas Cancer Center
Odessa, Texas
Hematology Oncology Associates
Phoenix, Arizona
Northwest Cancer Specialists
Portland, Oregon
Hematology Oncology Physicians of Texas
Richardson, Texas, 75080
Oncology and Hematology Associates of SW Virginia, Inc.
Salem, Virginia, 24153
Cancer Care Northwest
Spokane, Washington, 99202
Tyler Cancer Center
Tyler, Texas
About this study
Official title: An Open-label, Multicenter, Phase II Study of AT-101 in Combination With Rituximab in Patients With Untreated, Grade I-II, Follicular Non-Hodgkin's Lymphoma
This is a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the rituximab regimen, improvement to patients' response to the treatment will be observed verses rituximab alone.
Read the detailed description
Further Study Details provided by Ascenta.
- Conditions
- Follicular Lymphoma
- Being tested
- AT-101, Rituximab
- Keywords
- cancer, lymphoma, Non-Hodgkin's, Non-Hodgkins, AT-101, AT101, Rituxan, Rituximab
- Medical subject headings
- Lymphoma, Follicular, Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-101Drug
AT-101 30 mg orally for 21 of 56 days, every cycle. Cycle = 56 days; Max of 5 cycles.
RituximabDrug
Rituximab 375mg/m2 IV once per week for four weeks during 1st cycle, 375mg/m2 IV once per cycle for cycles 2-5. Cycle = 56 days; Max of 5 cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
complete or partial remission of disease
Measured: 8 weeks
Secondary outcomes (2)
duration of complete or partial remission of disease
Measured: 10 months
number of participants with adverse events
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startOct 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascenta Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lance Leopold, MD, Study director, Ascenta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440388
- Sponsor's protocol ID
- AT-101-CS-203
- Status last verified
- Aug 2010
- First submitted
- 23 Feb 2007
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase II Study of AT-101 in Combination With Rituximab in Patients With Untreated, Grade I-II, Follicular Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00440388
- Acronym / sponsor ID
- AT-101-CS-203
- Conditions
- Follicular Lymphoma
- Keywords
- cancer, lymphoma, Non-Hodgkin's, Non-Hodgkins, AT-101, AT101, Rituxan, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ascenta TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 27 Feb 2007 (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 a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the rituximab regimen, improvement to patients' response to the treatment will be observed verses rituximab alone.
Detailed description
Further Study Details provided by Ascenta.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed, previously untreated Grade I-II follicular B-cell non-Hodgkin's lymphoma (stage I, II, III and IV). Patients may have received radiation therapy to one lymph node region; Stage I or II patients must have relapsed after prior radiation therapy to be eligible;
- Patients with any FLIPI score may participate. Patients with FLIPI scores 3-5 may be enrolled with asymptomatic disease, or without worsening disease or disease related-symptoms; however patients with FLIPI scores of 0-2 must have evidence of worsening disease;
- ECOG performance status 0-1;
- Measurable disease;
- Adequate hematological function as indicated by:
Key exclusion criteria (5 listed)
- Patients who have severe lymphoma-related symptoms requiring a rapid response to therapy (e.g., requirement for cytoreduction due to advanced disease or organ compromise, respiratory compromise because of large effusions or airway obstruction, bowel obstruction, ureteral obstruction, and chylous ascites);
- Active symptomatic fungal, bacterial and/or viral infection including, but not limited to active HIV or viral hepatitis (A, B or C);
- History of hepatitis B infection;
- Any B-cell, T-cell or transformed lymphoma other than histologically confirmed follicular non-Hodgkin's lymphoma;
- Central nervous system (CNS) lymphoma, CNS or leptomeningeal involvement by lymphoma (treated or in remission), HIV-related lymphoma, or patients with symptoms suggesting HIV infection;
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-101AT-101 30 mg orally for 21 of 56 days, every cycle. Cycle = 56 days; Max of 5 cycles. | Drug | – |
| RituximabRituximab 375mg/m2 IV once per week for four weeks during 1st cycle, 375mg/m2 IV once per cycle for cycles 2-5. Cycle = 56 days; Max of 5 cycles. | Drug | – |
Primary outcome
complete or partial remission of disease
Time frame: 8 weeks
2 secondary outcomes
duration of complete or partial remission of disease
Time frame: 10 months
number of participants with adverse events
Time frame: 10 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 27 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.
Lance Leopold, MD study director
Ascenta Therapeutics, Inc.
28 sites 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 and Rituximab in people with Follicular Lymphoma, run by Ascenta Therapeutics at 28 sites 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 13 inclusion and 5 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 27 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 28 sites 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?
complete or partial remission of disease (time frame: 8 weeks). 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 27 Aug 2010.