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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT02059239
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bendamustine — DRUG
    Days - 24 and Day - 23 followed by a short break of 10 - 14 days.
  • Carmustine — DRUG
    300 mg/m2 on Day -6
  • Etoposide — DRUG
    100 mg/m2 on days -5 to -2
  • Melphalan — DRUG
    140mg/m2 on Day -1
  • Cytarabine — DRUG
    200 mg/m2 on days -5 to -2
  • Alemtuzumab — DRUG
    20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors
  • Autologous Stem Cell Transplantation — BIOLOGICAL
  • Allogeneic Stem Cell Transplantation — BIOLOGICAL
  • Rituximab — DRUG
    Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant

Study Details

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.

Key Dates

Start date
Jun 4, 2014
Status verified
Feb 2021
Primary completion
Dec 16, 2019
Completion
Jun 15, 2020

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemo plus Autologous Transplantation
    Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant
  • Experimental: Chemo plus Allogeneic Transplantation
    Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant

Primary Outcome Measure

Number of Patients Able to Proceed to Transplant [ Time Frame: 14 days after bendamustine treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical CollegeNew YorkNew York10065-

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By research site
Weill Cornell Medical College· New York, NY

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