Rituximab & Combination Chemotherapy Followed by Transplantation in Relapsed or Refractory Non-Hodgkin's Lymphoma

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT00007852
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • rituximab — BIOLOGICAL
    Rituximab at 375 mg/m2 administered approximately one week apart prior to collection of the hematopoietic stem cells. Rituxan at a dose of 375 mg/m2 IV will be given either on the days prior to initiation of the BCNU (days -10 to -7) or on the same day that the BCNU is administered for the BEAM chemotherapy regimen (Day -6). A fourth infusion of Rituxan 375 mg/m2 will be given at 30 day (+/- 20 days) post-transplant. At approximately 6 months post-transplant, if the patients have not had progressive lymphoma, they will receive four weekly doses of Rituxan 375 mg/m2 IV.
  • carmustine — DRUG
    BCNU 300 mg/M2 IV day -6
  • cytarabine — DRUG
    100 mg/m2 on days -5 through -2
  • etoposide — DRUG
    100mg/M2 BID on days -5 through -2
  • melphalan — DRUG
    140 mg/m2 IV on day -1
  • autologous hematopoietic stem cell transplantation — PROCEDURE
    Following the chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line

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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Key Dates

Start date
Sep 1, 2000
Status verified
Aug 2023
Primary completion
Jan 1, 2002
Completion
Jan 1, 2011

Study Design

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

Arms

  • Experimental: Arm I
    Rituxan and BEAM with autologous stem cell transplant

Primary Outcome Measure

100 day (complete + partial) response rate [ Time Frame: 100 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-

Find similar trials in Omaha, NE

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

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