Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma
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ClinicalTrials.gov Identifier: NCT00904722 |
Recruitment Status :
Completed
First Posted : May 20, 2009
Results First Posted : June 3, 2016
Last Update Posted : June 3, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | May 18, 2009 | |||
First Posted Date ICMJE | May 20, 2009 | |||
Results First Submitted Date ICMJE | April 27, 2016 | |||
Results First Posted Date ICMJE | June 3, 2016 | |||
Last Update Posted Date | June 3, 2016 | |||
Study Start Date ICMJE | January 2010 | |||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Response Rate [ Time Frame: Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse. ] Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.
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Original Primary Outcome Measures ICMJE |
Overall Response Rate [ Time Frame: 2 Years ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Progression-Free Survival [ Time Frame: Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse. ] Progression-Free Survival (PFS) was measured from enrollment to disease progression or recurrence or death from any cause.
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma | |||
Official Title ICMJE | Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma | |||
Brief Summary | The goal of this clinical research study is to learn if the combination of the immunotherapy drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug combination will also be studied. | |||
Detailed Description | The Study Drugs: Rituximab is designed to attach to lymphoma cells, which may cause them to die. CT-011 is designed to strengthen the immune system against cancer, possibly helping the immune cells kill the lymphoma cells better. Study Drug Administration: If you are found to be eligible to take part in this study, you will receive an infusion of CT-011 every 4 weeks for a total of 4 infusions. The first infusion will take at least 2 hours and will be given through a needle in your vein. Later infusions will take at least 1 hour. You must stay at the hospital for 2 hours after each infusion. If the lymphoma remains stable or is shrinking after 4 infusions of CT-011, you may receive 8 additional infusions of CT-011 every 4 weeks, for a total of 12 infusions. You will receive rituximab as an infusion through a needle in your vein once a week for a total of 4 infusions. The first infusion of rituximab will begin about 17 days after the first infusion of CT-011. Each rituximab infusion will be given over 4-8 hours. You will be watched carefully before, during, and after each CT-011 or rituximab infusion in case you experience any side effects to the drug. You will be given Benadryl (diphenhydramine) and Tylenol (acetaminophen) about 30 to 60 minutes before each infusion in order to lower the risk of possible side effects. If the doctor thinks it is needed, you may also be given other drugs such as hydrocortisone or prednisone (also known as corticosteroids) to help lower the risk of possible side effects. If the side effects become intolerable, and the doctor thinks it is necessary, the infusion may be stopped for a short time or stopped completely. Study Visits: The following tests will be performed at your scheduled study visits. Within 30 days before the first infusion of study drug (up to 2 weeks after the screening tests are complete):
Blood (about 1 teaspoon each time) will be drawn for research tests to check the levels of CT-011 in the blood and measure how your immune system responds to the drug. These will be drawn right after and then 2 hours after each infusion of CT-011, and on Days 7, 24, 31, 38, and 43. About 24 hours after the first CT-011 infusion: -Blood (about 2 ½ tablespoons) will be drawn for research tests to learn if the study drug activates the immune cells. Before the first rituximab infusion:
Before the second, third, and fourth CT-011 infusion:
Before the third CT-011 infusion:
About 4 weeks after the fourth infusion of CT-011:
Before CT-011 infusions 5 through 12:
Length of Study: You may continue receiving CT-011 for up to a total of 12 infusions. You will be taken off study if you have intolerable side effects or the disease gets worse. Long-Term Follow-Up: You will be asked to return to the clinic for the following long-term follow-up tests: About every 3 months after you complete 4 infusions of CT-011:
If your CT scans show that the lymphoma has gone away completely during the above visits, you may also have a PET scan and 2 bone marrow biopsies and 1 bone marrow aspirate collected to confirm the disease status. At 3, 6, 9, and 12 months after the end of treatment: -Blood (about 2 ½ tablespoons each time) will be drawn for immune-response research studies. This is an investigational study. Rituximab is FDA approved and commercially available for the treatment of non-Hodgkin's lymphomas, including follicular lymphoma. CT-011 is not FDA approved or commercially available. At this time, this drug is being used in research only. Up to 30 patients will take part in this study. All will be enrolled at MD Anderson. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Lymphoma | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: CT-011 in combination with Rituximab
Combination of the immunotherapy drugs, CT-011 and rituximab.
Interventions:
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Publications * | Westin JR, Chu F, Zhang M, Fayad LE, Kwak LW, Fowler N, Romaguera J, Hagemeister F, Fanale M, Samaniego F, Feng L, Baladandayuthapani V, Wang Z, Ma W, Gao Y, Wallace M, Vence LM, Radvanyi L, Muzzafar T, Rotem-Yehudar R, Davis RE, Neelapu SS. Safety and activity of PD1 blockade by pidilizumab in combination with rituximab in patients with relapsed follicular lymphoma: a single group, open-label, phase 2 trial. Lancet Oncol. 2014 Jan;15(1):69-77. doi: 10.1016/S1470-2045(13)70551-5. Epub 2013 Dec 11. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
32 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date ICMJE | April 2015 | |||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00904722 | |||
Other Study ID Numbers ICMJE | 2009-0163 NCI-2011-03225 ( Registry Identifier: NCI CTRP ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | M.D. Anderson Cancer Center | |||
Original Responsible Party | Sattva S. Neelapu, MD / Assistant Professor, UT MD Anderson Cancer Center | |||
Current Study Sponsor ICMJE | M.D. Anderson Cancer Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | CureTech Ltd | |||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | April 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |