Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT00856245
Phase
PHASE2
Status
Completed

Conditions

  • Non-Hodgkins Lymphoma

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.

Study Details

Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell transplantation will help patients get rid of their lymphoma cells from the bone marrow and stem cell collections.

Key Dates

Start date
Feb 28, 2009
Status verified
Apr 2017
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

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

Arms

  • Other: Rituximab
    Patients will be treated IV with rituximab at the rate of 50 milligrams per hour (mg/hour) for 1 hour. If patient tolerates the infusion, the rate is increased by increments of 50 mg/hour every 30 minutes to a maximum of 400 mg/hour. If patient has a severe reaction, the infusion is stopped temporarily and the infusion rate is decreased by 50%. Subsequent infusions are started at the rate of 100 mg/hour, increased by 100 mg/hour every 30 minutes to a maximum of 400 mg/hour if tolerated. Vital signs are monitored every 15 minutes for 2 hours and every 30 minutes thereafter.

Primary Outcome Measure

Rate of PCR Negativity [ Time Frame: up to 7 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160-
University of Kansas Medical Center, Westwood CampusKansas CityKansas66205-

Find similar trials in Kansas City, KS

By research site
University of Kansas Medical Center· Kansas City, KSUniversity of Kansas Medical Center, Westwood Campus· Kansas City, KS

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