Clinical trial NCT03054883: Observational Study for Patients With Newly Diagnosed (MCL) Not Eligible for High-dose Therapy
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mantle Cell Lymphoma
Keywords: Mantle Cell Lymphoma
minimal residual disease
cytosine arabinoside
Lead sponsor: Czech Lymphoma Study Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Czech Republic
First posted: 2017-02-16
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly and/or comorbid patients with newly dg. mantle cell lymphoma not eligible for high-dose therapy and autologous stem cell transplantation, eligible for R-CHOP or R-COEP (rituximab, cyclophosphamide, oncovin, etoposide, prednison) based therapy.

Brief summary: This is an observational study aimed to analyze the effectiveness of treatment of patients with newly dg. mantle cell lymphoma not eligible for high-dose therapy and autologous stem cell transplantation. Scheme of treatment: alternating cycles of R-CHOP (rituximab, cyclophosphamide, hydroxydaunomycin, oncovin, prednison) and R-AraC (rituximab, cytarabin): R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC. 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.

Detailed description: 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.

Baseline procedures:

* 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

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of MCL (hematopathologic examination in the reference centre, with evidence of cyclin D1 or translocation t(11;14) )
* not eligible for high-dose therapy with autologous stem cell transplantation
* eligible for R-CHOP or R-COEP-based therapy
* signed informed consent form with the study and data processing

Exclusion Criteria:

* non compliance of a patient
* CNS (central nervous system) involvement with lymphoma
* ECOG (Eastern Cooperative Oncology Group) \>3 or active uncontrolled comorbidities

Primary outcomes:
measure: Overall response
timeFrame: After induction for all patients, who can be evaluated; through study completion, an average of 1 year.
Secondary outcomes:
measure: Progression-free survival and overall survival
timeFrame: max. 4 years
measure: Minimal residual disease (MRD) by PCR (polymerase chain reaction) after induction
timeFrame: After induction for all patients, who can be evaluated; through study completion, an average of 1 year.
Other outcomes:
Locations:
Study officials:
affiliation: Charles University General Hospital in Prague
name: Marek Trneny, prof.,PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klener P, Fronkova E, Belada D, Forsterova K, Pytlik R, Kalinova M, Simkovic M, Salek D, Mocikova H, Prochazka V, Blahovcova P, Janikova A, Markova J, Obr A, Berkova A, Kubinyi J, Vaskova M, Mejstrikova E, Campr V, Jaksa R, Kodet R, Michalova K, Trka J, Trneny M. Alternating R-CHOP and R-cytarabine is a safe and effective regimen for transplant-ineligible patients with a newly diagnosed mantle cell lymphoma. Hematol Oncol. 2018 Feb;36(1):110-115. doi: 10.1002/hon.2483. Epub 2017 Oct 30.