Clinical trial · Interventional
Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma
Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Procarbazine | Drug | Procarbazine | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab + standard chemotherapy
- description
- Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.
- interventionNames
- Biological: Rituximab
- Drug: Cytarabine
- Drug: Dexamethasone
- Drug: Leucovorin
- Drug: Methotrexate
- Drug: Procarbazine
- Drug: Vincristine
Primary outcomes (1)
- measure
- Complete Response Rate - Locally Reviewed
- timeFrame
- For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).
- description
- Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites. Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically confirmed non-Hodgkin's lymphoma by brain biopsy * Patients with inconclusive biopsy or patients who are not candidates for biopsy must have typical CT scan or MRI of the brain AND meet ≥ 1 of the following criteria: * Positive cerebrospinal fluid cytology for lymphoma OR a monoclonal lymphoid population as defined by cell surface markers or immunoglobulin gene rearrangement studies * Biopsy-proven involvement of the vitreous or uvea if cells are apparent in the posterior chamber or vitreous by ophthalmological examination * Bideminsionally measurable disease, defined as contrast-enhancing tumor ≥ 1 cm by pretreatment MRI/CT scan * Meningeal or vitreous involvement constitutes evaluable but not measurable disease * If an excisional, rather than a needle biopsy was done, measurable disease must be present on a postoperative scan (not a PET-CT scan) * ECOG performance status 0-3 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ upper limit of normal (ULN) * SGOT ≤ 2.0 times ULN * Creatinine clearance ≥ 50 mL/min * Negative pregnancy test * Fertile patients must use effective contraception Exclusion criteria: * Pregnant or nursing * HIV-1 positivity * Other malignancy within the past 5 years except basal cell skin cancer or any carcinoma in situ * Pre-existing immunodeficiency * Hepatitis B surface antigen positivity * Systemic lymphoma (as determined by pre-registration CT scans and physical examination) * Prior chemotherapy or radiotherapy for primary central nervous system lymphoma * Prior organ or bone marrow transplantation
References
Publications (1)
- DERIVEDSwinnen LJ, O'Neill A, Imus PH, Gujar S, Schiff D, Kleinberg LR, Advani RH, Dunbar EM, Moore D, Grossman SA. Phase II study of rituximab given in conjunction with standard chemotherapy in primary central nervous system lymphoma (PCNSL): a trial of the ECOG-ACRIN cancer research group (E1F05). Oncotarget. 2017 Nov 6;9(1):766-773. doi: 10.18632/oncotarget.22332. eCollection 2018 Jan 2. PMID 29416652