Observational Study for Patients With Newly Diagnosed (MCL) Not Eligible for High-dose Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03054883|
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
|Condition or disease|
|Mantle Cell Lymphoma|
This is an observational study considered for patients with mantle cell lymphoma meeting the basic inclusion criteria. The study will enrol patients who will be treated according to standard protocol used in the hematologic department. Scheme of treatment: alternating cycles of R-CHOP and R-AraC: R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC.
- CT or PET-CT (positron emission tomography with computed tomography)before starting treatment, after 3 cycles and at the end of treatment (after 6 cycles)
- bone marrow examination before therapy, after 3 cycles and after completion of induction
- maintenance rituximab based of standards of each centre
The study was proposed based on the previously published data in the younger patients, which demonstrated improved outcome after implementation of Ara-C into induction.
Primary objectives include response after induction by PET-CT and PFS (progression-free survival).
Secondary objectives include OS (overall survival), and prognostic significance of minimal residual disease detection after completion of induction
|Study Type :||Observational|
|Actual Enrollment :||73 participants|
|Official Title:||Observational Study for Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) Not Eligible for High-dose Therapy According to the Protocol Alternating R-CHOP and R-cytarabine Chemotherapy Regimen (3+3 Cycles)|
|Actual Study Start Date :||April 1, 2012|
|Actual Primary Completion Date :||December 31, 2015|
|Actual Study Completion Date :||December 31, 2016|
- Overall response [ Time Frame: After induction for all patients, who can be evaluated; through study completion, an average of 1 year. ]PET-CT after induction, and bone marrow examination after induction
- Progression-free survival and overall survival [ Time Frame: max. 4 years ]PFS will be calculated from initiation of therapy until lymphoma relapse / progression or death from any cause; OS will be calculated from initiation of therapy until death from any cause
- Minimal residual disease (MRD) by PCR (polymerase chain reaction) after induction [ Time Frame: After induction for all patients, who can be evaluated; through study completion, an average of 1 year. ]After completion of induction MRD will be evaluated by PCR in the peripheral blood and bone marrow in those patients with available disease markers, i.e. primers detecting the translocation t(11;14) or unique IgVH rearrangement.
Biospecimen Retention: Samples With DNA
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): NCT03054883
|Principal Investigator:||Marek Trneny, prof.,PhD.||Charles University General Hospital in Prague|