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Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma

StatusCompleted
PhasePhase 2
Started2012-09
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Trial completed
Primary completion pushed: 2020-12-10 → 2021-01-14
Study completion confirmed: February 2022 (last estimated May 2027)
2026-01-14
Study Status, Baseline Characteristics v25
Re-verified, no change to tracked fields
2025-12-23
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v24
Primary completion dateestimated 2026-10→confirmed 2020-12-10
Completion datenot stated→2027-05-02
Results first postednot stated→2026-01-14
Secondary endpoints3 entries, revised
eventEvent freeFree survivalSurvival numberNumber of participantsParticipants withWith treatmentTreatment-related adverseAdverse eventsEvents as assessedAssessed by CTCAE v4.0 overallOverall survivalSurvival
Primary endpoints1 entry, revised
progressionProgression freeFree survivalSurvival
2021-08-16
3 amendments v21-v23
3 re-verifications since 2019-01-22, no change to tracked fields
2017-05-02
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v20
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 110→confirmed 113
Study sites127→126
Show 19 earlier versions
2017-04-19
Study Status, Contacts/Locations v19
Study sitesdetails revised at 11 of 127 sites
2017-03-06
Study Status, Contacts/Locations v18
Study sites110→127
2017-02-01
Study Status, Study Design, Eligibility v17
Enrollment target160→110
Eligibility criteria-228 characters
[...] ce or history of non-Hodgkin lymphoma (NHL) outside of CNS. Patients must have no isolated ocular lymphoma. Previous Treatment: Patients must have no prior chemotherapy [...] rsing Status - Patients must be non-pregnant and non-nursing. Due; to the unknown teratogenic potential of this regimen, pregnant or nursing patients may not be enrolled. Womenwomen of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration. In; in addition, women and men of childbearing potential must comm [...] f contraception throughout their participation in this study; due to the [...] [...]
2016-11-16
Study Identification, Study Status v16
Re-verified, no change to tracked fields
2016-06-20
Study Status, Contacts/Locations v15
Study sites59→110
2015-10-20
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v14
Interventionscarmustine (Drug), cytarabine (Drug), etoposide (Drug), filgrastim (Procedure), thiotepa (Drug), transplant (Procedure)→G-CSF (Drug), carmustine (Drug), cytarabine (Drug), etoposide (Drug), stem cell transplant (Procedure), thiotepa (Drug)
Eligibility criteria+238 characters
DISEASEDocumentation CHARACTERISTICSof Disease: Diagnosis of primary central nervous system (CNS) diffuse large B-cell lymphoma confirmed by one of the following: Brain brain biopsy or resection Cerebrospinal, cerebrospinal fluid Vitreous and vitreous fluid. NoOther Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS. NoPatients must have no isolated ocular lymphoma. NoPrevious Treatment: Patients must have no prior chemotherapy or radiation therapy for lymphoma. PATIENTAge- CHARACTERISTICS:Patients must be between the ages of 18 and 75 years. Karn [...] [...]
Secondary endpoints3 entries, revised
EFSevent free survival Toxicitynumber rateof participants with treatment-related adverse events as assessed by CTCAE v4.0 OSoverall survival
Primary endpoints1 entry, revised
Two-yearprogression PFSfree survival
Study description-2,963 characters
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 OBJECTIVESSecondary Objectives: Primary To compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of high-dose therapy (HDT)/autologous stem cell transplant (ASCT) versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and eto [...] To c [...] [...]
2015-08-28
Study Status v13
Primary completion date2020-04→2026-10
2015-08-03
Study Status v12
Primary completion date2016-04→2020-04
2015-07-30
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v11
Primary completion date2014-04→2016-04
Study sites14→59
Lead sponsorCancer and Leukemia Group B→Alliance for Clinical Trials in Oncology
Interventionsautologous hematopoietic stem cell transplantation (Procedure), carmustine (Drug), cytarabine (Drug), etoposide (Drug), peripheral blood…→carmustine (Drug), cytarabine (Drug), etoposide (Drug), filgrastim (Procedure), thiotepa (Drug), transplant (Procedure)
Eligibility criteria+165 characters
[...] in lymphoma (NHL) outside of CNS No isolated ocular lymphoma No prior chemotherapy or isolatedradiation leptomeningealtherapy for lymphoma At least one measurable, contrast-enhancing brain lesion (≥ 1 cm in length) PATIENT CHARACTERISTICS: Karnofsky performance status ≥ 30% (≥ 50% for patients ages 60-70 years) AdequatePatients cardiacmust functionbe (left ventricular ejection fraction [LVEF] ≥ 50%)non-pregnant and pulmonary function (corrected diffusion capacity of carbon monoxide [DLCO] ≥ 60% predicted) Pregnant or non-nursing patients may not be enrolled; women of childbearing potential mus [...] [...]
Secondary endpoints2 to 3 entries
EFS and OS estimated for each arm by Kaplan-Meier method, and compared between the two arms using the log-rank test Toxicity rate compared between the arms using Fisher's exact method OS
2013-02-02
Study Status, Contacts/Locations v10
Study sites11→14
2013-01-17
Study Status, Study Description v9
Study description+1 characters
[...] lly (PO) on days 7-11 (courses 1-4); and cytarabine IV over 12 hourhours twice daily (BID) on days 1 and 2 (course 5 only). Treatmen [...]
2012-12-18
Study Status, Contacts/Locations v8
Study sites8→11
2012-11-14
Study Status, Contacts/Locations v7
Study sites7→8
2012-11-11
Study Status, Contacts/Locations v6
Study sites6→7
2012-11-08
Study Status, Contacts/Locations v5
Study sites5→6
2012-10-24
Study Status, Contacts/Locations v4
Study sites2→5
2012-09-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2012-01→2012-09
Study sites0→2
2012-09-19
Study Status v2
Re-verified, no change to tracked fields
2012-05-30
Study Status, Study Description, Arms and Interventions, Eligibility v1
Eligibility criteria+62 characters
[...] minotransferase (ALT) ≤ 2 times upper limit of normal (ULN) BilirubinTotal bilirubin ≤ 3 mg/dL Creatinine clearance ≥ 50 mL/min Platelet count ≥ 100,000/mcL PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiation therapy for lymphoma No history of organ transplantation or ongoing immunosuppressant therapy No concurrent palliative radiotherapy
Study description+23 characters
[...] 105 Companion Study). OUTLINE: This is a multicenter study. ⇅ moved Patients are stratified according to age and Karnofsky performance status (KPS) (age < 51 years vs age ≥ 51 years and KPS ≥ 70% vs age ≥ 51 years and KPS < 70%). Induction Chemotherapy: Patients receive methotrexate IV ove [...] ransplantation on day 0. Arm II: Beginning at least 8 weeks and no later than 16 weeks after completionday 1 of induction therapycourse 5, patients receive cytarabine IV over 2 hours on days 1-4, a [...]
2012-01-13
Original filing
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.
Trial Details
NCT Number NCT01511562
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Lymphoma
Enrollment 113 participants
Start Date 2012-09
Primary Completion 2021-01-14 (estimated)
Study Completion 2022-02-24 (estimated)
Updated on ClinicalTrials.gov 2026-09-24