CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
High-dose chemotherapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01182415
NCT01182415Phase 2Completed

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

Massachusetts General Hospital·interventional·Posted Aug 16, 2010·Updated Apr 6, 2023

In Brief

A Phase 2 clinical trial evaluating Autologous stem cell transplant and High-dose chemotherapy for Non-Hodgkin's Lymphoma and CNS Lymphoma. Completed, enrolled 30 participants across 2 sites.

Detailed Summary

Current standard treatments for lymphoma involving the central nervous system include chemotherapy or whole brain radiation therapy (WBRT). However, many patients do not respond to this treatment, and some of the patients who do respond relapse after treatment. Previous research has shown that a stem cell transplant of a patient's own cells (autologous stem cell transplant) may be more effective for some patients with lymphoma involving the CNS. In previous research using autologous stem cell transplants for lymphoma involving the CNS, a conditioning regimen consisting of the drugs thiotepa, busulfan and cyclophosphamide (TCE) was used. These drugs have been shown to enter the nervous system. In this research study, the investigators are adding the drug rituximab (Rituxan) to the drug cytarabine for the stem cell mobilization process. Cytarabine is a standard drug for mobilization. In addition, rituximab will be added to the conditioning regimen of thiotepa, busulfan and cyclophosphamide. Rituximab is approved by the FDA for the treatment of some types of lymphomas, but is not approved for use in lymphomas that involve the CNS. Rituximab is known to be able to enter the CNS. Previous research has suggested that it may help treat lymphoma that involves the CNS. The goal of this research study is to see if adding rituximab to the stem cell mobilization and conditioning regimens helps treat lymphoma that involves the central nervous system.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2010
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2015
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.9 years ago

Interventions

Autologous stem cell transplantprocedure

Autologous stem cell transplant following high-dose chemotherapy

High-dose chemotherapydrug

High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide