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History of Changes for Study: NCT02313389
Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma (BLOCAGE-01)
Latest version (submitted February 10, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 9, 2014 None (earliest Version on record)
2 July 20, 2015 Study Status
3 May 20, 2016 Recruitment Status, Study Status, IPDSharing and Contacts/Locations
4 October 13, 2016 Study Description and Study Status
5 November 4, 2016 Study Status and Conditions
6 March 1, 2018 Study Status
7 August 19, 2019 Study Status
8 February 10, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02313389
Submitted Date:  December 9, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: P130950
Brief Title: Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma (BLOCAGE-01)
Official Title: Phase III Trial Evaluating Maintenance Treatment Versus Observation in Elderly Patients Suffering From Primary Central Nervous System Lymphoma in Complete Remission After High Dose Methotrexate Based Chemotherapy in First Line
Secondary IDs: 2014-002597-37 [EudraCT Number]
Open or close this module Study Status
Record Verification: December 2014
Overall Status: Not yet recruiting
Study Start: January 2015
Primary Completion: June 2019 [Anticipated]
Study Completion: June 2021 [Anticipated]
First Submitted: December 5, 2014
First Submitted that
Met QC Criteria:
December 9, 2014
First Posted: December 10, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 9, 2014
Last Update Posted: December 10, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Assistance Publique - Hôpitaux de Paris
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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
Detailed Description:

Objectives

  • The primary objective is to evaluate the benefit estimated by the PFS associated with maintenance chemotherapy compared to observation in patients ≥ 60 years having achieved a complete response after a high-dose MTX based induction chemotherapy
  • The secondary objectives are to assess:
    • Overall survival
    • Safety of maintenance chemotherapy
    • Neurocognitive outcome
    • Quality of life of the patients

Inclusion and exclusion criteria

At registration

  • Inclusion criteria
    • Newly diagnosed primary cerebral lymphoma
    • Age >60 years
    • Pathology proven diagnosis
    • 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
  • Non inclusion criteria
    • 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

At randomization

  • Complete response on MRI after induction chemotherapy according to the IPCG criteria
  • Karnofsky Performance Status >40
  • Adequate haematological, renal and hepatic function

Study Design

  • This study is an open label multicenter randomized phase III trial comparing maintenance chemotherapy versus observation in complete responders to high dose MTX based induction chemotherapy.
  • Patients are registered to participate in the study at time of initial diagnosis and study enrolment before the induction chemotherapy.
  • Induction chemotherapy (R-MPVA protocol) includes 4 to 5 monthly cycles of high dose MTX (3.5g/m2, D1 and D15), procarbazine, vincristine, rituximab followed by one cycle of high dose cytarabine consolidation.
  • Randomization to observation (arm 1) or maintenance (arm 2) will be carried out only for patients in complete response (CR) after induction chemotherapy Arm 1: Observation Arm 2: Seven monthly R-MT cycles including high dose MTX (3.5g/m2, D1), TMZ, rituximab

Sample size, duration of the study, feasibility

  • 295 patients need to be enrolled to randomize 192 patients
  • Duration of the study: 6 years (accrual period= 4 years; minimal follow-up = 2 years)

    26 participating expert centers from the national LOC network

The trial is supported by the neurooncology ANOCEF and the lymphoma LYSA clinical research groups.

Open or close this module Conditions
Conditions: Primary CNS Lymphoma.
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 295 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: maintenance chemotherapy

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
Seven monthly R-MT cycles including high dose MTX (3.5g/m2, D1), TMZ, rituximab.
No Intervention: observation

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

Open or close this module Outcome Measures
Primary Outcome Measures:
1. progression free survival
[ Time Frame: 6 years ]

Secondary Outcome Measures:
1. overall survival
[ Time Frame: 6 years ]

2. Toxicity graded according to the NCI-CTCAE
[ Time Frame: 6 years ]

Toxicity graded according to the NCI-CTCAE
3. Cognitive functions evaluated by a standardized and validated test battery exploring 5 cognitive domains
[ Time Frame: 6 years ]

Cognitive functions evaluated by a standardized and validated test battery exploring 5 cognitive domains
4. Quality of life
[ Time Frame: 6 years ]

Quality of life assessed by the EORTC QLC-C30 questionnaire and the brain cancer module (BCM20)
Open or close this module Eligibility
Minimum Age: 60 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion criteria At registration Inclusion criteria

  • 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

Exclusion criteria

  • 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
Open or close this module Contacts/Locations
Central Contact Person: Khe HOANG-XUAN, MD, PhD
Telephone: +33 - 1.42.16.03.81
Email: khe.hoang-xuan@psl.aphp.fr
Study Officials: Khe HOANG-XUAN, Md, PhD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Locations: France
Groupe Hospitalier Pitie Salpetriere
Paris, France, 75013
Contact:Contact: Khe HOANG-XUAN, MD, PhD +33 - 1.42.16.03.81 khe.hoang-xuan@psl.aphp.fr
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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