Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma

NCT02313389 | Unknown Phase 3

• 2 other identifiers: P1309502014-002597-37
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis Our hypothesis is that maintenance chemotherapy will prolong complete remission obtained after a standard induction chemotherapy with an acceptable toxicity in the elderly. Rationale

• Treatment of the elderly is challenging, indeed age over 60 is associated both with a poor prognosis and a high risk of treatment induced neurotoxicity with devastating consequences on quality of life. Therefore it has become standard practice to treat elderly in first line with high-dose methotrexate (MTX) based polychemotherapy alone, avoiding whole brain radiotherapy (WBRT) or deferring it for recurrence.
• There is a clear need to improve disease control after induction chemotherapy. Since consolidation with WBRT or intensive chemotherapy with autologous stem cell rescue are either poorly effective and/or too toxic in the elderly population, maintenance chemotherapy is an interesting alternative approach. Several agents, such as high-dose MTX, temozolomide (TMZ), rituximab, with a reported activity in PCNSL and acceptable safety profile, as single agent or combined, are good candidates for maintenance

Conditions

Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• progression free survival

  6 years

Secondary Outcomes (4)

• overall survival

  6 years

• Toxicity graded according to the NCI-CTCAE

  6 years

• Cognitive functions evaluated by a standardized and validated test battery exploring 5 cognitive domains

  6 years

• Quality of life

  6 years

Study Arms (2)

maintenance chemotherapy

EXPERIMENTAL

Clinical examination and MRI will be performed every 3 months for 2 years and then every 6 months until tumor progression. Neurocognitive tests will be performed at randomization and annually. Quality of life questionnaires at randomisation and every 3 months

Drug: Rituximab, Methotrexate, Temozolomide

observation

NO INTERVENTION

Clinical examination and MRI will be performed every 3 months for 2 years and then every 6 months until tumor progression. Neurocognitive tests will be performed at randomization and annually. Quality of life questionnaires at randomisation and every 3 months

Interventions

Rituximab, Methotrexate, Temozolomide DRUG

Seven monthly R-MT cycles including high dose MTX (3.5g/m2, D1), TMZ, rituximab.

maintenance chemotherapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed primary cerebral lymphoma
• Age ≥60 years
• Pathology proven diagnosis or positive cytology of the CSF or vitreous
• Karnofsky Performance Status ≥40
• No evidence of systemic NHL (body CT scan, bone marrow biopsy)
• Adequate haematological, renal and hepatic function
• Calculated creatinine clearance \> 40 ml/min
• At randomization
• Complete response on MRI after induction chemotherapy according to the IPCG criteria
• Karnofsky Performance Status ≥40
• Adequate haematological, renal and hepatic function

You may not qualify if:

• Positive HIV serology
• Preexisting immunodeficiency (organ transplant recipient)
• Prior treatment for PCNSL
• Isolated primary intra-ocular lymphoma
• Low grade lymphoma
• Any other active primary malignancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitie Salpetriere

Paris, 75013, France

Location

Related Publications (1)

• Rozenblum L, Houillier C, Baptiste A, Soussain C, Edeline V, Naggara P, Soret M, Causse-Lemercier V, Willems L, Choquet S, Ursu R, Galanaud D, Belin L, Hoang-Xuan K, Kas A. Interim FDG-PET improves treatment failure prediction in primary central nervous system lymphoma: An LOC network prospective multicentric study. Neuro Oncol. 2024 Jul 5;26(7):1292-1301. doi: 10.1093/neuonc/noae029.

  PMID: 38366824 DERIVED

MeSH Terms

Interventions

Rituximab; Methotrexate; Temozolomide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Khe HOANG-XUAN, Md, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 10, 2014
• Study Start: September 1, 2015
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)