Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
NCIC Clinical Trials Group
Study ID
NCT00078949
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • rituximab — BIOLOGICAL
    Given IV
  • cisplatin — DRUG
    Given IV
  • cytarabine — DRUG
    Given IV
  • dexamethasone — DRUG
    Given IV
  • gemcitabine hydrochloride — DRUG
    Given IV

Study Details

RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving rituximab as maintenance therapy after stem cell transplantation may kill any remaining cancer cells. It is not yet known which salvage chemotherapy regimen is more effective before autologous stem cell transplantation in treating relapsed or refractory non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying salvage chemotherapy using dexamethasone, cisplatin, and gemcitabine to see how well it works compared to dexamethasone, cisplatin, and cytarabine given before autologous stem cell transplantation in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. This trial also is studying giving rituximab as maintenance therapy to see how well it works compared to no further therapy after stem cell transplantation. Rituximab was added to both salvage treatment arms for CD20+ patients in a protocol amendment in 2005.

Key Dates

Start date
Aug 27, 2003
Status verified
Mar 2020
Primary completion
Jul 29, 2013
Completion
Dec 31, 2018

Study Design

Enrollment
849 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Salvage arm I
    Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.
  • Experimental: Salvage arm II
    Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.
  • Experimental: Maintenance arm I
    Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.
  • No Intervention: Maintenance arm II
    Patients undergo observation only.

Primary Outcome Measure

Response Rate of Patients After 2 Courses of Chemotherapy [ Time Frame: After 2 cycle of treatment ]

Locations (5)

FacilityCityStateZIPSite coordinators
Rush-Presbyterian-St. Luke's Medical CentreChicagoIllinois60612-
Indiana University Medical CenterIndianapolisIndiana46202-
Hackensack University Medical CenterHackensackNew Jersey07601-
University of Cincinnati, Barrett Cancer CentreCincinnatiOhio45219-
University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-

Find similar trials in Chicago, IL

By research site
Rush-Presbyterian-St. Luke's Medical Centre· Chicago, ILIndiana University Medical Center· Indianapolis, INHackensack University Medical Center· Hackensack, NJUniversity of Cincinnati, Barrett Cancer Centre· Cincinnati, OHUniversity of Pittsburgh Cancer Institute· Pittsburgh, PA

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