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NCT01011920 · REGISTRY CONDITION SEARCH

Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2026-03-19

This is a multicenter open label randomized phase II trial. Enrolled Primary Central Nervous System Lymphoma (PCNSL) patients will be stratified according to the IELSG score and randomized to receive one of the follows as primary chemotherapy: * Arm A: Methotrexate (MTX) + Cytarabine (Ara-C) * Arm B: MTX + Ara-C + rituximab * Arm C: MTX + Ara-C + rituximab + thiotepa. Chemotherapy will be administered every three weeks. The maximum number of chemotherapy induction courses will be 4. Patients in Stable Disease (SD) or better after two courses will receive two more courses of the same primary chemotherapy regimen. Stem-cells harvest will be performed in the three arms after the second course. After 4 courses response assessment will be performed. Patients who will not achieve SD or better after the 4th course, as well as those who will experience Progressive Disease (PD) at any time and those who will not achieve a sufficient stem cell harvest, will receive Whole Brain Radiation Therapy (WBRT) 36-40 Gy +/- tumor bed boost of 9 Gy. Patients who will achieve SD or better after the 4th course will be stratified according to objective response to primary chemotherapy and to primary chemotherapy regimen and randomly allocated to receive as consolidation therapy one of the follows: * Arm D: WBRT 36 Gy +/- boost 9 Gy * Arm E: Carmustine (BCNU) + Thiotepa + Autologous Peripheral Blood Stem Cell Transplant (APBSCT) Patients in Complete Response (CR) after WBRT or APBSCT will remain in follow-up. Patients who will not achieve a CR after WBRT will be managed according to physician's preferences. Patients who will not achieve a CR after APBSCT will be referred to WBRT.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Complete Remission Rate After Primary Chemotherapy

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outcome · POSTED

2 Years Failure Free Survival (FFS) After Second Randomization

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outcome · POSTED

2 Years Failure Free Survival (FFS)

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outcome · POSTED

2 Year Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histological or cytological assessed diagnosis of non-Hodgkin's lymphoma. * Diagnostic sample obtained by stereotactic or surgical biopsy, Cerebrospinal Fluid (CSF) cytology examination or vitrectomy. * Disease exclusively localized into the central nervous system, CSF, cranial nerves or eyes. * At least one measurable lesion. * Previously untreated patients (previous or ongoing steroid therapy admitted). * Age 18-65 years (with ECOG Performance Status 0-3) or 66-70 (with ECOG Performance Status 0-2). * Adequate bone marrow, renal, cardiac, and hepatic function. * Sexually active patients of childbearing potential agreeing in implementing adequate contraceptive measures during study participation. * Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. * Patient-signed informed consent obtained before registration. Exclusion Criteria: * Patients with lymphomatous lesions outside the CNS. * Patients with a previous non-Hodgkin lymphoma at any time. * Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years. * HBsAg and HCV positivity. * HIV infection, previous organ transplantation or other clinically evident form of immunodeficiency. * Concurrent treatment with other experimental drugs. * Concurrent Pregnancy or lactation. * Patients not agreeing to take adequate contraceptive measures during the study. * Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease).
healthy Volunteers
false
maximum Age
65 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
    intervention Names
    1. Drug: Methotrexate
    2. Drug: Ara-C
    label
    MTX + AraC
    type
    EXPERIMENTAL
  2. description
    Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
    intervention Names
    1. Drug: Methotrexate
    2. Drug: Ara-C
    3. Drug: Rituximab
    label
    MTX + Ara-C + Rituximab
    type
    EXPERIMENTAL
  3. description
    Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
    intervention Names
    1. Drug: Methotrexate
    2. Drug: Ara-C
    3. Drug: Rituximab
    4. Drug: Thiotepa
    label
    MTX + Ara-C + rituximab+thiotepa
    type
    EXPERIMENTAL
  4. description
    ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
    intervention Names
    1. Radiation: radiotherapy
    label
    WBRT 36 Gy +/- boost 9 Gy
    type
    EXPERIMENTAL
  5. description
    Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0
    intervention Names
    1. Drug: Thiotepa
    2. Drug: BCNU
    3. Other: APBSCT
    label
    BCNU + Thiotepa + APBSCT
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. MTX + Ara-C + Rituximab
    2. MTX + Ara-C + rituximab+thiotepa
    3. MTX + AraC
    description
    Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
    name
    Methotrexate
    type
    DRUG
  2. arm Group Labels
    1. MTX + Ara-C + Rituximab
    2. MTX + Ara-C + rituximab+thiotepa
    3. MTX + AraC
    description
    Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
    name
    Ara-C
    other Names
    1. Cytarabine
    type
    DRUG
  3. arm Group Labels
    1. MTX + Ara-C + Rituximab
    2. MTX + Ara-C + rituximab+thiotepa
    description
    Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
    name
    Rituximab
    other Names
    1. MabThera
    type
    DRUG
  4. arm Group Labels
    1. BCNU + Thiotepa + APBSCT
    2. MTX + Ara-C + rituximab+thiotepa
    description
    ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
    name
    Thiotepa
    type
    DRUG
  5. arm Group Labels
    1. WBRT 36 Gy +/- boost 9 Gy
    description
    Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
    name
    radiotherapy
    type
    RADIATION
  6. arm Group Labels
    1. BCNU + Thiotepa + APBSCT
    description
    BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
    name
    BCNU
    other Names
    1. Carmustine
    type
    DRUG
  7. arm Group Labels
    1. BCNU + Thiotepa + APBSCT
    description
    Autologous peripheral blood stem cell transplant (APBSCT)
    name
    APBSCT
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
227
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Percentage of patients with complete remission after 3 month of treatment. Percentage values are rounded to whole numbers.
    measure
    Complete Remission Rate After Primary Chemotherapy
    time Frame
    3 months after treatment start
  2. description
    Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry. Percentage values are rounded to whole numbers.
    measure
    2 Years Failure Free Survival (FFS) After Second Randomization
    time Frame
    Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry
secondary Outcomes
  1. description
    Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry any cause. Percentage values are rounded to whole numbers.
    measure
    2 Years Failure Free Survival (FFS)
    time Frame
    Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry
  2. description
    Percentage of patients alive after 2 years from study entry. Percentage values are rounded to whole numbers.
    measure
    2 Year Overall Survival (OS)
    time Frame
    From study entry until 2 years after
Full study description
brief Summary
This is a multicenter open label randomized phase II trial. Enrolled Primary Central Nervous System Lymphoma (PCNSL) patients will be stratified according to the IELSG score and randomized to receive one of the follows as primary chemotherapy: * Arm A: Methotrexate (MTX) + Cytarabine (Ara-C) * Arm B: MTX + Ara-C + rituximab * Arm C: MTX + Ara-C + rituximab + thiotepa. Chemotherapy will be administered every three weeks. The maximum number of chemotherapy induction courses will be 4. Patients in Stable Disease (SD) or better after two courses will receive two more courses of the same primary chemotherapy regimen. Stem-cells harvest will be performed in the three arms after the second course. After 4 courses response assessment will be performed. Patients who will not achieve SD or better after the 4th course, as well as those who will experience Progressive Disease (PD) at any time and those who will not achieve a sufficient stem cell harvest, will receive Whole Brain Radiation Therapy (WBRT) 36-40 Gy +/- tumor bed boost of 9 Gy. Patients who will achieve SD or better after the 4th course will be stratified according to objective response to primary chemotherapy and to primary chemotherapy regimen and randomly allocated to receive as consolidation therapy one of the follows: * Arm D: WBRT 36 Gy +/- boost 9 Gy * Arm E: Carmustine (BCNU) + Thiotepa + Autologous Peripheral Blood Stem Cell Transplant (APBSCT) Patients in Complete Response (CR) after WBRT or APBSCT will remain in follow-up. Patients who will not achieve a CR after WBRT will be managed according to physician's preferences. Patients who will not achieve a CR after APBSCT will be referred to WBRT.
Source references
references
  1. citation
    Ferreri AJM, Cwynarski K, Pulczynski E, Fox CP, Schorb E, La Rosee P, Binder M, Fabbri A, Torri V, Minacapelli E, Falautano M, Ilariucci F, Ambrosetti A, Roth A, Hemmaway C, Johnson P, Linton KM, Pukrop T, Sonderskov Gorlov J, Balzarotti M, Hess G, Keller U, Stilgenbauer S, Panse J, Tucci A, Orsucci L, Pisani F, Levis A, Krause SW, Schmoll HJ, Hertenstein B, Rummel M, Smith J, Pfreundschuh M, Cabras G, Angrilli F, Ponzoni M, Deckert M, Politi LS, Finke J, Reni M, Cavalli F, Zucca E, Illerhaus G; International Extranodal Lymphoma Study Group (IELSG). Whole-brain radiotherapy or autologous stem-cell transplantation as consolidation strategies after high-dose methotrexate-based chemoimmunotherapy in patients with primary CNS lymphoma: results of the second randomisation of the International Extranodal Lymphoma Study Group-32 phase 2 trial. Lancet Haematol. 2017 Nov;4(11):e510-e523. doi: 10.1016/S2352-3026(17)30174-6. Epub 2017 Oct 17.
    pmid
    29054815
    type
    DERIVED
  2. citation
    Ferreri AJ, Cwynarski K, Pulczynski E, Ponzoni M, Deckert M, Politi LS, Torri V, Fox CP, Rosee PL, Schorb E, Ambrosetti A, Roth A, Hemmaway C, Ferrari A, Linton KM, Ruda R, Binder M, Pukrop T, Balzarotti M, Fabbri A, Johnson P, Gorlov JS, Hess G, Panse J, Pisani F, Tucci A, Stilgenbauer S, Hertenstein B, Keller U, Krause SW, Levis A, Schmoll HJ, Cavalli F, Finke J, Reni M, Zucca E, Illerhaus G; International Extranodal Lymphoma Study Group (IELSG). Chemoimmunotherapy with methotrexate, cytarabine, thiotepa, and rituximab (MATRix regimen) in patients with primary CNS lymphoma: results of the first randomisation of the International Extranodal Lymphoma Study Group-32 (IELSG32) phase 2 trial. Lancet Haematol. 2016 May;3(5):e217-27. doi: 10.1016/S2352-3026(16)00036-3. Epub 2016 Apr 6.
    pmid
    27132696
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      edge id
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      nct id
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      occurrences
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        exact text
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        start
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      offset unit
      unicode_code_points
      query cond
      Primary Central Nervous System Lymphoma
      query disease state id
      ds-primary-central-nervous-system-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-primary-central-nervous-system-lymphoma-000.json
      source file sha256
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      source kind
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice