Clinical trial · Observational
Observational Study for Patients With Newly Diagnosed (MCL) Not Eligible for High-dose Therapy
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall response
- timeFrame
- After induction for all patients, who can be evaluated; through study completion, an average of 1 year.
- description
- PET-CT after induction, and bone marrow examination after induction
Secondary outcomes (2)
- measure
- Progression-free survival and overall survival
- timeFrame
- max. 4 years
- description
- 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
- 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.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKlener 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. PMID 29083050