Neoplasms

Blood and Lymph Conditions

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Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

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Antineoplastic Agents

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Micronutrients

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Methotrexate

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Folic Acid

Vitamin B Complex

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Folinic Acid

Folate

Vitamin B9

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).

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).

Patients with 0-1 risk factor for CNS relapse will not receive CNS prophylaxis.

Heidi Mocikova, M.D., Ph.D.

Andrea Janikova, M.D.,Ph.D.

David Belada, M.D., Ph.D.

Juraj Ďuraš, M.D.

Martin Pachner, M.D.

Robert Pytlik, M.D.

Marek Trněný, prof.M.D.

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).

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.

CNS Prophylaxis in Diffuse Large B-cell Lymphoma

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

Czech Lymphoma Study Group

Nervous System Diseases

Symptoms and General Pathology

Meningeal Carcinomatosis

Meningitis

Neuroinflammatory Diseases

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Rituximab

Antineoplastic Agents, Immunological

intrathecal rituximab

Annarita Conconi, MD

Andres JM Ferreri, MD

The purpose of this study is to define the safety profile of rituximab given intrathecally in lymphomatous meningitis related to CD20+ non-Hodgkin's lymphomas.

A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis

International Extranodal Lymphoma Study Group (IELSG)

Leukemia

Anti-Infective Agents

Cytarabine

Antiviral Agents

50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses

cytarabine liposome injection

David Rizzieri, MD

The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of symptoms to the study drug will also be determined.

DepoCyt is a sustained-release formulation of the chemotherapy drug, cytarabine (Ara-C), which is used for the treatment of patients with lymphomatous or leukemic meningitis, a complication of lymphoma/leukemia that is characterized by the spread of cancer to the central nervous system.

DepoCyt is introduced into the spinal fluid, through a needle inserted into the spinal canal or through a reservoir placed under the scalp by a neurosurgeon. DepoCyt will be given every two weeks i.e. week 1 and week 3 initially. After the second dose, a lumbar puncture will be done to check the spinal fluid for cancer cells. If there has been a good response, DepoCyt will be given every 14 days for 6 doses i.e., weeks 5, 7, 9, 11, 13, 15 and then every 28 days for six doses i.e., weeks 19, 23, 27, 31, 35, and 39. Blood tests and lumbar punctures will be done throughout the study.

DepoCyt for Active Lymphomatous or Leukemic Meningitis

Phase II Study of Intrathecal Therapy With DepoCyt for Active Lymphomatous or Leukemic Meningitis

To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.

Enzon Pharmaceuticals, Inc.

Duke University

Subjects with Lymphomatous or Leukemic Meningitis.

All Subjects

Lymphomatous

Leukemic

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Adverse events for both arms, lymphomatous and leukemic, were combined due to low accrual and early study termination.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CNS Prophylaxis in Diffuse Large B-cell Lymphoma	NCT02777736	Diffuse Large B...	Methotrexate	18 Years - 72 Years	Czech Lymphoma Study Group
CNS Prophylaxis in Diffuse Large B-cell Lymphoma	NCT02777736	Diffuse Large B...	Methotrexate	18 Years - 72 Years	Czech Lymphoma Study Group
A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis	NCT00210340	Lymphoma, B Cel...	intrathecal rit...	18 Years -	International Extranodal Lymphoma Study Group (IELSG)
DepoCyt for Active Lymphomatous or Leukemic Meningitis	NCT00523939	Neoplastic Meni... Lymphoma, B Cel...	cytarabine lipo...	18 Years -	Duke University
A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis	NCT00210340	Lymphoma, B Cel...	intrathecal rit...	18 Years -	International Extranodal Lymphoma Study Group (IELSG)

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