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CNS Prophylaxis in Diffuse Large B-cell Lymphoma (CLSG-CNS-001)

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: NCT02777736
Recruitment Status : Unknown
Verified June 2016 by Czech Lymphoma Study Group.
Recruitment status was:  Recruiting
First Posted : May 19, 2016
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Czech Lymphoma Study Group

Brief Summary:
Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS prophylaxis (arm C).

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Methotrexate Phase 3

Detailed Description:

Patients with diffuse large B-cell lymphoma are evaluated for risk factors of CNS relapse during initial staging (age > 60years, lactate dehydrogenase (LDH) > reference range, clinical stage III/IV, performance status according to Eastern Cooperative Oncology Group (ECOG) >1, kidney and/or adrenal gland involvement, involvement > 1 extranodal organ) including evaluation of cerebrospinal fluid.

All patients with systemic DLBCL without CNS involvement are treated with systemic chemotherapy: either 6 cycles of R CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednison) +2xR (rituximab) or 6 cycles of DA EPOCH R (dose adjusted etoposide, prednison, vincristin, cyclophosphamide, doxorubicin) +2xR (rituximab). Patients with ≥ 2 risk factors for CNS relapse or with occult meningeal involvement will be randomized in 1:1 ratio either into arm A with 2 cycles of prophylactic methotrexate 3g/m2 i.v., or into arm B with prophylactic 6x intrathecal methotrexate 12mg (1x intrathecal methotrexate in each cycle of systemic chemotherapy). Patients with 0-1 risk factor will be allocated into arm C without CNS prophylaxis. Patients will be observed for CNS relapse during the follow-up of 1year after the end of the first-line treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study Evaluating Relapses in Central Nervous System in Patients With Diffuse Large B-Cell Lymphoma Treated With Chemotherapy With or Without CNS Prophylaxis. Multicentric, Prospective, Randomized Phase III Study
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Arm A - Methotrexate i.v.
Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive 2 cycles of methotrexate 3g/m2 i.v. after the 3rd and 6th cycle of systemic chemotherapy (R CHOP or DA EPOCH R).
Drug: Methotrexate
i.v. or intrathecal CNS prophylaxis
Other Names:
  • Methotrexate,manufactured by EBEWE
  • Methotrexate, manufactured by HOSPIRA

Active Comparator: Arm B - Methotrexate i.t.
Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive intrathecal methotrexate 12mg in each cycle of systemic chemotherapy (6x).
Drug: Methotrexate
i.v. or intrathecal CNS prophylaxis
Other Names:
  • Methotrexate,manufactured by EBEWE
  • Methotrexate, manufactured by HOSPIRA

No Intervention: Arm C - no Methotrexate
Patients with 0-1 risk factor for CNS relapse will not receive CNS prophylaxis.



Primary Outcome Measures :
  1. Cumulative incidence of CNS relapse in patients treated either with methotrexate i.v. or methotrexate i.t. or without CNS prophylaxis [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Complete remission rate [ Time Frame: 1 year ]
  2. Overall response rate [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: 2 years ]
  4. Progression-free survival [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed DLBCL
  • age 18-72 years
  • signed informed consent with the study
  • first-line treatment 6 cycles of R CHOP +2x R or 6 cycles of DA EPOCH R+ 2xR

Exclusion Criteria:

  • DLBCL and concomitant initial CNS involvement
  • PMBL (primary mediastinal B-cell lymphoma)
  • treatment with another chemotherapy than R CHOP or DA EPOCH R
  • HIV positive, or active hepatitis B or C
  • other concomitant serious disease (based on the decision of the physician-investigator)
  • non-compliance of a patient
  • any contraindication for application of anthracycline based chemotherapy or high dose methotrexate
  • pregnancy or breast-feeding

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): NCT02777736


Contacts
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Contact: Heidi Mocikova, M.D., Ph.D. +420267163554 heidi.mocikova@fnkv.cz

Locations
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Czech Republic
University Hospital Brno-Bohunice Recruiting
Brno, Czech Republic, 62500
Contact: Andrea Janikova, M.D.,Ph.D.         
University Hospital Hradec Králové Recruiting
Hradec Králové, Czech Republic, 50005
Contact: David Belada, M.D., Ph.D.         
University Hospital Ostrava Recruiting
Ostrava, Czech Republic, 708 52
Contact: Juraj Ďuraš, M.D.         
University Hospital Pilsen Recruiting
Pilsen, Czech Republic, 304 60
Contact: Martin Pachner, M.D.         
University Hospital Kralovske Vinohrady Recruiting
Prague, Czech Republic, 100 34
Contact: Heidi Mocikova, M.D., Ph.D.         
General University Hospital Prague Recruiting
Prague, Czech Republic, 12808
Contact: Robert Pytlik, M.D.         
Sponsors and Collaborators
Czech Lymphoma Study Group
Investigators
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Principal Investigator: Heidi Mocikova, M.D., Ph.D. University Hospital Kralovske Vinohrady, Prague, Czech Republic
Study Director: Marek Trněný, prof.M.D. General University Hospital, Prague
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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Responsible Party: Czech Lymphoma Study Group
ClinicalTrials.gov Identifier: NCT02777736    
Other Study ID Numbers: CLSG-CNS-001
2015-000591-97 ( EudraCT Number )
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Czech Lymphoma Study Group:
Lymphoma, B cell
Central nervous system relapse
Methotrexate
Intrathecal chemotherapy
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors