CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Bendamustine +8 moredrug
Likely dose
Carmustine 300 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02059239
NCT02059239Phase 2Completed

A Pilot Study of a Sequential Regimen of Intensive Chemotherapy Followed by Autologous or Allogeneic Transplantation for Refractory Lymphoma (Non-Hodgkin's and Hodgkin's) and Phase 2 Expansion Cohort

Weill Medical College of Cornell University·interventional·Posted Feb 11, 2014·Updated Feb 21, 2021

In Brief

A Phase 2 clinical trial evaluating Bendamustine, Carmustine, and 7 other interventions for Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma. Completed, enrolled 34 participants across 1 site.

Detailed Summary

This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did not respond to treatment or has returned after responding to previous therapy, and who are in need of a stem cell transplant. The purpose of this study is to test the safety and effectiveness of giving the drug Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell transplant for lymphoma that has not achieved a complete response to salvage (treatment used for relapsed disease) chemotherapy.

Study Details

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

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2014
Enrollment StartJun 4, 2014
Primary CompletionDec 16, 2019
Study CompletionJun 15, 2020
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 12.4 years ago

Interventions

Bendamustinedrug

Days - 24 and Day - 23 followed by a short break of 10 - 14 days.

Carmustinedrug

300 mg/m2 on Day -6

Etoposidedrug

100 mg/m2 on days -5 to -2

Melphalandrug

140mg/m2 on Day -1

Cytarabinedrug

200 mg/m2 on days -5 to -2

Alemtuzumabdrug

20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors

Autologous Stem Cell Transplantationbiological

Allogeneic Stem Cell Transplantationbiological

Rituximabdrug

Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant