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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

Tracking Information
First Submitted Date  ICMJE May 12, 2016
First Posted Date  ICMJE May 19, 2016
Last Update Posted Date June 6, 2016
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • Complete remission rate [ Time Frame: 1 year ]
  • Overall response rate [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 2 years ]
  • Progression-free survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CNS Prophylaxis in Diffuse Large B-cell Lymphoma
Official Title  ICMJE 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
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diffuse Large B-cell Lymphoma
Intervention  ICMJE Drug: Methotrexate
i.v. or intrathecal CNS prophylaxis
Other Names:
  • Methotrexate,manufactured by EBEWE
  • Methotrexate, manufactured by HOSPIRA
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Methotrexate
  • 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).
    Intervention: Drug: Methotrexate
  • No Intervention: Arm C - no Methotrexate
    Patients with 0-1 risk factor for CNS relapse will not receive CNS prophylaxis.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 17, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02777736
Other Study ID Numbers  ICMJE CLSG-CNS-001
2015-000591-97 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Czech Lymphoma Study Group
Study Sponsor  ICMJE Czech Lymphoma Study Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Czech Lymphoma Study Group
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP