Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
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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: NCT01458730 |
Recruitment Status :
Completed
First Posted : October 25, 2011
Last Update Posted : August 4, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Central Nervous System Lymphoma | Drug: Immunochemotherapy | Phase 2 |
The objective of the study is
- To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma
- To assess the long term outcome concerning neurotoxicity
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Immunochemotherapy in Primary Central Nervous System Lymphoma With Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Ifosfamide, Vincristine, Vindesine, Temozolomide and DepoCyte Induction Followed by Maintenance Treatment in Elderly Patients With Temozolomide. |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | August 2022 |

- Drug: Immunochemotherapy
Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte
- Overall survival
- response rate [ Time Frame: at completion of therapy ]
- neurotoxicity [ Time Frame: 1-10 years after completion of therapy ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment.
- Patients treated with steroids alone are eligible
- No signs of lymphoma outside the CNS
- ECOG performance status 0-4
- Age > 17 and < 76 years
- Written informed consent from the patient or guardian
Exclusion Criteria:
- Cardiac failure > 3
- Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
- Previous malignancy unless disease free for at least five years
- Active infection.
- Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre.
- Positive HIV status
- Organ transplantation
- Serious psychiatric illness
- Prior radiotherapy to the brain
- Concomitant anti-inflammatory medication that cannot be discontinued
- Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula
- Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
- Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper limits of normal.
- Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study

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): NCT01458730
Denmark | |
Elisa Jacobsen Pulczynski | |
Aarhus, Denmark, DK-8000 |
Responsible Party: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT01458730 |
Other Study ID Numbers: |
EudraCT No 2006-004772-12 |
First Posted: | October 25, 2011 Key Record Dates |
Last Update Posted: | August 4, 2022 |
Last Verified: | August 2022 |
PCNSL Immunochemotherapy Intraspinal Depocyt Maintenance temozolomide |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |