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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
Sponsor:
Collaborator:
Ministry of Health, Czech Republic
Information provided by (Responsible Party):
Czech Lymphoma Study Group

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.

Condition or disease
Mantle Cell Lymphoma

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

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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Czech Lymphoma Study Group
Ministry of Health, Czech Republic
Investigators
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Principal Investigator: Marek Trneny, prof.,PhD. Charles University General Hospital in Prague
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Czech Lymphoma Study Group
ClinicalTrials.gov Identifier: NCT03054883    
Other Study ID Numbers: CLSG-MCL-01
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Czech Lymphoma Study Group:
Mantle Cell Lymphoma
minimal residual disease
cytosine arabinoside
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin