Evidence map›Paper›PMID 25204639›Full record

Trial reportCancer2015

Phase 2 trial of high-dose rituximab with high-dose cytarabine mobilization therapy and high-dose thiotepa, busulfan, and cyclophosphamide autologous stem cell transplantation in patients with central nervous system involvement by non-Hodgkin lymphoma.

Yi-Bin Chen, Tracy Batchelor, Shuli Li, Ephraim Hochberg, Mark Brezina, Sooae Jones, Candice Del Rio, Morgan Curtis, Karen K Ballen, Jeffrey Barnes and 10 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01182415 (Phase II Trial of Hihg-Dose Thiotepa, Busulfan, Cyclophosphamide, and Rituximab With Autologous Stem Cell Transplantation for Patients With CNS Involvement by Non-Hodgkin's Lymphoma or Primary CNS Lymphoma), which is not on this map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
5.8field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01182415 phase2completednot on this map

Phase II Trial of Hihg-Dose Thiotepa, Busulfan, Cyclophosphamide, and Rituximab With Autologous Stem Cell Transplantation for Patients With CNS Involvement by Non-Hodgkin's Lymphoma or Primary CNS Lymphoma

TypeinterventionalSponsorMassachusetts General HospitalRan2010 to 2016Enrolled30ConditionsNon-Hodgkin's Lymphoma, CNS LymphomaArmsAutologous stem cell transplant, High-dose chemotherapy
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  6. Article
  7. Article
  8. Economic Evaluation of Ready-to-Dilute Thiotepa (TepyluteClinicoEconomics and outcomes research : CEOR · 2026
    Article
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  14. Review
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  20. Consolidation Therapy in Primary Central Nervous System Lymphoma.Current treatment options in oncology · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 2 institutions in 1 country.

Yi-Bin ChenBone Marrow Transplant Unit, Massachusetts General Hospital, Boston, Massachusetts.
Tracy Batchelor
Shuli Li
Ephraim Hochberg
Mark Brezina
Sooae Jones
Candice Del Rio
Morgan Curtis
Karen K Ballen
Jeffrey Barnes
Andrew S Chi
Jorg Dietrich
Jessica Driscoll
Elizabeth R Gertsner
Fred Hochberg
Ann S LaCasce
Steven L McAfee
Thomas R Spitzer
Lakshmi Nayak
Philippe Armand
Massachusetts General Hospital · USDana-Farber Cancer Institute · US

Funding

VectorP30CA006516 · NCI · DANA-FARBER CANCER INSTITUTE · PI A. Heather Eliassen · 1985 to 2026
$330.6M
Clinical and Molecular Studies of Novel Therapeutics in Malignant Brain TumorsK24CA125440 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI BATCHELOR, TRACY T · 2007 to 2016
$1.9M
NCI NIH HHS CA 006516NCI NIH HHS K24 CA125440NCI NIH HHS P30 CA006516
6 · The paper itself

Abstract

backgroundHigh-dose thiotepa, busulfan, and cyclophosphamide (TBC) with autologous stem cell transplantation (ASCT) has been used in patients with central nervous system (CNS) involvement by non-Hodgkin lymphoma (NHL). Despite limited penetration into the CNS, rituximab is active in primary CNS NHL. Therefore, high-dose rituximab was combined with TBC for ASCT in patients with CNS NHL.

methodsA single-arm phase 2 trial using high-dose rituximab with cytarabine for stem cell mobilization followed by high-dose rituximab combined with thiotepa, busulfan, and cyclophosphamide (R-TBC) for ASCT was conducted. Doses of rituximab at 1000 mg/m(2) were given on days 1 and 8 of mobilization and on days -9 and -2 of TBC. The primary endpoint was efficacy.

resultsThirty patients were enrolled. Eighteen patients had primary CNS NHL (12 with complete remission (CR)/first partial remission (PR1) and 6 with CR/PR2), and 12 patients had secondary CNS lymphoma (5 with CR/PR1 and 7 with CR/PR2 or beyond). All patients were in partial or complete remission. Twenty-nine patients proceeded to R-TBC ASCT. Two patients developed significant neurotoxicity. The 100-day nonrelapse mortality rate was 0%, and 1 patient died because of nonrelapse causes 5 months after ASCT. For all patients, at a median follow-up of 24 months (range, 12-40 months), the estimated 2-year progression-free survival rate was 81% (95% confidence interval, 59%-92%), and the 2-year overall survival rate was 93% (95% confidence interval, 76%-98%). There were no relapses or deaths among the 18 patients with primary CNS lymphoma.

conclusionsFor patients with CNS involvement by B-cell NHL and especially for patients with primary CNS NHL, R-TBC ASCT shows encouraging activity and merits further study.

Indexed as

AdultAgedAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsBusulfanCentral Nervous System NeoplasmsCyclophosphamideCytarabineDisease-Free SurvivalDrug Administration ScheduleFemaleHematopoietic Stem Cell TransplantationHumansInduction ChemotherapyInfusions, IntravenousLymphoma, Non-HodgkinAntibodies, Monoclonal, Murine-DerivedBusulfanCyclophosphamideCytarabineRituximabThiotepaautologous transplantbusulfancentral nervous system (CNS) lymphomacyclophosphamide (TBC)rituximabthiotepa

Identifiers

PMID25204639
PMCPMC4293259
OpenAlexW1582073907

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.