Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02242097|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2014
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Contiguous Stage II Mantle Cell Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Stage I Mantle Cell Lymphoma Stage III Mantle Cell Lymphoma Stage IV Mantle Cell Lymphoma||Drug: ibrutinib Other: laboratory biomarker analysis||Phase 2|
I. To determine the progression-free survival (PFS) rate after 2 years.
I. Assess toxicity. II. Determine rates of conversion from partial response (PR) to complete response (CR).
III. Determine median overall survival (OS) after 4 years.
I. Compare minimal residual disease (MRD) results overtime by polymerase chain reaction (PCR) and correlate these with PFS and OS.
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity or patient preference.
After completion of study treatment, patients who completed 4 years of treatment are followed up at 30 days. Patients who did not complete 4 years of treatment are followed up for up to 4 years post-first dose of treatment (every 3 months for 2 years and then every 6 months for 4 years).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial Evaluating Ibrutinib Maintenance Following Intensive Induction for Patients With Previously Untreated Mantle Cell Lymphoma (MCL)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Treatment (ibrutinib)
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
Other: laboratory biomarker analysis
- Determine the progression-free survival (PFS) rate after 2 years [ Time Frame: Assessed at 2 years ]PFS will be measured from start of treatment to time of progression. Evidence of clinical progression will be documented by imaging (CT scan) for patients who have measurable disease.
- Incidence of adverse events, defined according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days after completion of study treatment, maximum 4 years post-first dose ]To assess toxicity, all adverse events will be summarized as to type, severity, frequency, timing and attribution.
- Rate of conversion from Partial Response (PR) to Complete Response (CR) [ Time Frame: Up to 4 years ]Progression will be evaluated using Cheson 2007 criteria, only patients who had a PR at the time of registration and who complete ≥ 1 complete cycle of ibrutinib maintenance therapy will be evaluable for this endpoint.
- Determine median Overall Survival (OS) after 4 years [ Time Frame: Up to 4 years post-first dose ]Patients will be evaluated monthly for the first 6 months on treatment, then every 3 months thereafter. Patients who go off treatment will continue to be followed for up to 4 years post-first dose. Follow-up will occur every 3 months (up to 2 years after the first dose of treatment) and then every 6 months thereafter (up to 4 years post-first dose). Median OS after 4 years will be calculated.
- Compare Minimum Residual Disease (MRD) results overtime by Polymerase Chain Reaction (PCR) and correlate these with PFS and OS [ Time Frame: Four time-points: baseline (pre-treatment), after 1 month and 6 months of treatment, and approximately 18-24 months post-first dose of treatment ]Archived tissue from a previous biopsy from all patients will be obtained for baseline clone identification; in addition, peripheral whole blood samples will be collected at four time points. MRD analysis will be conducted using PCR methods and results will be compared over time and correlated with PFS and OS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242097
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Northwestern University- Lake Forest Hospital|
|Lake Forest, Illinois, United States, 60045|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Barbara Pro, MD||Northwestern University|