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Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma

NCT02059239 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-02-21

Study results available
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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.

Conditions

  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Bendamustine

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

DRUG

Carmustine

300 mg/m2 on Day -6

DRUG

Etoposide

100 mg/m2 on days -5 to -2

DRUG

Melphalan

140mg/m2 on Day -1

DRUG

Cytarabine

200 mg/m2 on days -5 to -2

DRUG

Alemtuzumab

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

BIOLOGICAL

Autologous Stem Cell Transplantation

BIOLOGICAL

Allogeneic Stem Cell Transplantation

DRUG

Rituximab

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

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Tsiporah Shore, MD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-04
Primary Completion
2019-12-16
Completion
2020-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059239 on ClinicalTrials.gov