Mantle Cell LymphomaNCT03054883
Observational Study for Patients With Newly Diagnosed (MCL) Not Eligible for High-dose Therapy
An observational study of Mantle Cell Lymphoma, run by Czech Lymphoma Study Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2012to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- non compliance of a patient
- CNS (central nervous system) involvement with lymphoma
- ECOG (Eastern Cooperative Oncology Group) >3 or active uncontrolled comorbidities
About this study
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)
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.
Read the 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
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Mantle Cell Lymphoma, minimal residual disease, cytosine arabinoside
- Medical subject headings
- Lymphoma, Mantle-Cell, Neoplasm, Residual
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response
PET-CT after induction, and bone marrow examination after induction
Measured: 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
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
Measured: max. 4 years
Minimal residual disease (MRD) by PCR (polymerase chain reaction) after induction
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.
Measured: After induction for all patients, who can be evaluated; through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Apr 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Lymphoma Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Marek Trneny, prof.,PhD., Principal investigator, Charles University General Hospital in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054883
- Sponsor's protocol ID
- CLSG-MCL-01
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29083050
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03054883
- Acronym / sponsor ID
- CLSG-MCL-01
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Mantle Cell Lymphoma, minimal residual disease, cytosine arabinoside
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Czech Lymphoma Study GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- non compliance of a patient
- CNS (central nervous system) involvement with lymphoma
- ECOG (Eastern Cooperative Oncology Group) >3 or active uncontrolled comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Progression-free survival and overall survival
Time frame: max. 4 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Derived from this study: PubMed 29083050Klener 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.
- Official Site of the Czech Lymphoma Study GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mantle Cell Lymphoma
RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Lymphoma
Not yet recruitingPhase 2
A Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in People With Mantle Cell Lymphoma
Mantle Cell Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Trneny, prof.,PhD. principal investigator
Charles University General Hospital in Prague
Questions about this trial
What is this clinical trial studying?
An observational study of Mantle Cell Lymphoma, run by Czech Lymphoma Study Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response (time frame: After induction for all patients, who can be evaluated; through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.