Rituximab, Carmustine; Cytarabine, Etoposide, & Melphalan; Stem Cell Transplantation for Non-Hodgkin's Lymphoma

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT00080886
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
  • carmustine — DRUG
  • cytarabine — DRUG
  • etoposide — DRUG
  • melphalan — DRUG
  • autologous bone marrow transplantation — PROCEDURE
  • peripheral blood stem cell transplantation — PROCEDURE

Study Details

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkin's lymphoma.

Key Dates

Start date
May 8, 2002
Status verified
Oct 2023
Primary completion
Nov 1, 2005
Completion
Mar 12, 2015

Study Design

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

Arms

  • Other: Arm 1
    Participants receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest. Participants then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Participants undergo autologous hematopoietic stem cell transplantation on day 0. Participants who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks. Participants are followed at day 100, at 1 year, and then annually thereafter.

Primary Outcome Measure

evaluation of the relationship between levels of sCD20 in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous peripheral blood progenitor cell transplantation (PBPCT) as they relate to clinical outcomes. [ Time Frame: pre and post transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical Center, Eppley Cancer CenterOmahaNebraska68198-7680-

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center, Eppley Cancer Center· Omaha, NE

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