NCT03054883

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

3.8 years

First QC Date

February 9, 2017

Last Update Submit

February 13, 2017

Conditions

Mantle Cell Lymphoma

Keywords

Mantle Cell Lymphomaminimal residual diseasecytosine arabinoside

Outcome Measures

Primary Outcomes (1)

  • Overall response

    PET-CT after induction, and bone marrow examination after induction

    After induction for all patients, who can be evaluated; through study completion, an average of 1 year.

Secondary Outcomes (2)

  • Progression-free survival and overall survival

    max. 4 years

  • Minimal residual disease (MRD) by PCR (polymerase chain reaction) after induction

    After induction for all patients, who can be evaluated; through study completion, an average of 1 year.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29083050DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Isolation of DNA from leukemized peripheral blood or infiltrated bone marrow will be used for set up of patient-specific primers for detection of minimal residual disease after induction.

MeSH Terms

Conditions

Lymphoma, Mantle-CellNeoplasm, Residual

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marek Trneny, prof.,PhD.

    Charles University General Hospital in Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 16, 2017

Study Start

April 1, 2012

Primary Completion

December 31, 2015

Study Completion

December 31, 2016

Last Updated

February 16, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share