Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT02728531
Phase
PHASE1
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bendamustine — DRUG
  • Rituximab — DRUG
  • Cytarabine — DRUG
  • Pegfilgrastim — DRUG
  • Leukapheresis — PROCEDURE
  • Filgrastim — DRUG
  • Autologous stem cell transplant — PROCEDURE

Study Details

Given the established role of high dose cytarabine (HiDAC) combined with rituximab, along with recent data showing the encouraging efficacy of bendamustine, the investigators seek to integrate the synergistic effects of these medicines in alternating cycles as induction therapy prior to autologous stem cell transplant (ASCT). Based on prior experience with bendamustine and rituximab (BR) based induction therapy, the investigators seek to evaluate the efficacy and safety of stem cell mobilization in this pilot study

Key Dates

Start date
Apr 18, 2016
Status verified
Oct 2023
Primary completion
Jan 16, 2019
Completion
Aug 16, 2023

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bendamustine, Rituximab, Cytarabine
    * Bendamustine on Days 1 and 2 of Cycles 1, 3, and 5. * In Cycle 1, rituximab on Day 1 or 2 at the investigator's discretion. Given on Day 1 of Cycles 2 through 6. * On Days 1 and 2 of Cycles 2, 4, and 6, cytarabine will be administered every 12 hours for a total of 4 doses. * Growth factor will be administered subcutaneously within 72 hours of completion of each even-numbered cycles of chemotherapy. * Leukapheresis will begin when the total WBC ≥ 5000/ μL and continue daily until collection of ≥ 2x106 CD34+ cells/kg (with a maximum of 5 courses of apheresis). * Standard of care peripheral blood autologous stem cell harvest will proceed per institutional guidelines and begin during Cycle 6 following rituximab and cytarabine therapy, when the total WBC ≥ 5000/ μL. Collection will continue on a daily basis until collection of ≥ 2x106 CD34+ cells/kg.

Primary Outcome Measure

Stem cell mobilization success rate [ Time Frame: Completion of stem cell mobilization (approximately 25 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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