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NCT01511562 · REGISTRY CONDITION SEARCH

Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell 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
ACTIVE NOT RECRUITING
Registry last update
2026-01-30

The purpose of this study is to find out what effects (good and/or bad) treatment with chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell lymphoma is not known.

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

Progression Free Survival

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outcome · POSTED

Event Free Survival

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outcome · POSTED

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

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outcome · POSTED

Overall Survival

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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
1. Documentation of Disease: Diagnosis of primary CNS diffuse large B-cell lymphoma confirmed by one of the following: brain biopsy or resection, cerebrospinal fluid and vitreous fluid. 2. Other Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS. 3. Previous Treatment: Patients must have no prior chemotherapy or radiation therapy for lymphoma. 4. Age- Patients must be between the ages of 18 and 75 years. 5. Karnofsky Performance Scale - Patients must measure Karnofsky Performance Scale ≥ 30 (≥ 50 for patients ages 60-70). 6. Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom) 7. HIV - Patients must have negative HIV serology. 8. Hepatitis - Patients must have negative HCV serology (unless HBsAb positive patient has recently received HBV vaccine, in this case HBcAb should be negative). All patients must be screened for hepatitis B infection before starting treatment. Those patients who test positive for hepatitis B should be closely monitored for evidence of active HBV infection and hepatitis during and for several months after rituximab treatment. PCNSL patients with a history of hepatitis B infection should be treated with entecavir or lamivudine (physician discretion for choice of drug) as antiviral prophylaxis to prevent hepatitis B reactivation. 9. Organ Transplant or Immunosuppressant Therapy - Patient must have no history of organ transplantation or ongoing immunosuppressant therapy. 10. Required Initial Laboratory Values: ANC ≥ 1500/mcL, AST and ALT \< 2 x upper limit of normal (ULN), total bilirubin ≤ 3 mg/dL, creatinine clearance ≥ 50 mL/min, platelet count ≥ 100,000/mcL
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
    intervention Names
    1. Drug: carmustine
    2. Drug: thiotepa
    3. Procedure: stem cell transplant
    4. Drug: G-CSF
    label
    Arm I
    type
    OTHER
  2. description
    Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
    intervention Names
    1. Drug: cytarabine
    2. Drug: etoposide
    3. Drug: G-CSF
    label
    Arm II
    type
    OTHER
interventions
  1. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    carmustine
    type
    DRUG
  2. arm Group Labels
    1. Arm II
    description
    Given IV
    name
    cytarabine
    type
    DRUG
  3. arm Group Labels
    1. Arm II
    description
    Given IV
    name
    etoposide
    type
    DRUG
  4. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    thiotepa
    type
    DRUG
  5. arm Group Labels
    1. Arm I
    name
    stem cell transplant
    type
    PROCEDURE
  6. arm Group Labels
    1. Arm I
    2. Arm II
    name
    G-CSF
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
113
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The primary endpoint is to compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide. PFS time = time from Registration to earliest date of Progression or Death due to any cause, censoring non-progressed and alive patients at the date of last disease status evaluation. Response will be defined using the modified IPCG criteria. Progressive disease is defined as \> 25% increase in contrast-enhancing CNS (brain and spine if latter abnormal at baseline) disease, appearance of any new, measurable (\>/= 10mm) contrast-enhancing disease or recurrent or new ocular or CSF disease.
    measure
    Progression Free Survival
    time Frame
    2 years
secondary Outcomes
  1. description
    To compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. EFS event = same definition as PFS with non-protocol treatment also considered an event
    measure
    Event Free Survival
    time Frame
    2 years
  2. description
    Number of patients reporting at least one adverse event at least possibly related to treatment.
    measure
    Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
    time Frame
    7 years
  3. description
    To compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. OS event = Registration/Randomization to Death due to any cause
    measure
    Overall Survival
    time Frame
    2 years
Full study description
brief Summary
The purpose of this study is to find out what effects (good and/or bad) treatment with chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell lymphoma is not known.
detailed Description
Primary Objective: To compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide Secondary Objectives: 1. To compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine 2. To compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine 3. To assess the toxicities associated with consolidation HDT/ASCT versus consolidation consisting of etoposide and cytarabine 4. To determine diffusion MRI metrics (ADCmini, ADC25%, and ADCmean) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101) 5. To determine brain FDG-PET metrics (tumor SUV and tumor versus background SUV) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101) 6. To determine whether low baseline ADC measurements are associated with shorter PFS and OS (CALGB 581101) 7. To determine whether reduction in tumor SUV by \> 25% on brain FDG-PET/CT after one cycle of induction therapy is associated with improved PFS and OS (CALGB 581101) 8. To determine which IHC-based biomarkers are predictive of an adverse prognosis (CALGB 151113) 9. To determine which IHC-based biomarkers are predictive of a favorable prognosis (CALGB 151113) for BCL6 (B-cell CLL/lymphoma 6), and STAT 6 (signal transducer and activator of transcription 6, interleukin-4 induced) 10. To analyze tumor tissue for gene expression profiles, and to correlate these profiles with treatment outcomes (CALGB 151113) 11. To determine whether CSF proteome is a predictor of outcomes (prognostic marker) irrespective of treatment arm (CALGB 151113) for (IL-10 (interleukin 10) and C3 (complement component 3) 12. To assess the neurocognitive function of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy (etoposide and cytarabine) as measured by serial administration of the International PCNSL Collaborative Group (IPCG) neurocognitive battery and evaluate the long-term survivorship differences between the two arms (CALGB 71105)
Source references
references
  1. citation
    Batchelor TT, Giri S, Ruppert AS, Geyer SM, Smith SE, Mohile N, Swinnen LJ, Friedberg JW, Kahl BS, Bartlett NL, Hsi ED, Cheson BD, Wagner-Johnston N, Nayak L, Leonard JP, Rubenstein JL. Myeloablative vs nonmyeloablative consolidation for primary central nervous system lymphoma: results of Alliance 51101. Blood Adv. 2024 Jun 25;8(12):3189-3199. doi: 10.1182/bloodadvances.2023011657.
    pmid
    38598710
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-7e15e6b61304c3b8e92a
      requested nct id
      NCT01511562
      primary nct id
      NCT01511562
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      5133d5efc2041fb2554b035b378f2db0c15cad34dada88cd170d20b9c4e7432a
      payload sha256
      38507b3a87c0e0e599d8c4735a63bf4b7811432a06be51eac7daab57e0cf3d97
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-7e15e6b61304c3b8e92a
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01511562
      occurrences
      1. context exact
        NCT01511562
        end
        11
        exact text
        NCT01511562
        start
        0
      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
      5133d5efc2041fb2554b035b378f2db0c15cad34dada88cd170d20b9c4e7432a
      source json pointer
      /studies/16/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      583059d95b1564bca83e1d8a0fddfe599206015b29d221ae4af73f31d8427e2d

    Preserved source evidence · Not medical advice