Phase 2 N=19 Treatment

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

Non-Hodgkins Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00856245 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Rate of PCR Negativity — 14 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rituximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Kansas Medical Center
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of PCR Negativity	14	—
SECONDARY Progression Free Survival (PFS) and Overall Survival (OS)	24; 36; 36; 48	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Patients with biopsy-proven refractory CD20+ (cluster of differentiation antigen 20) Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 (complete remission 1) or later.
Patients must be transplant eligible per KUCC BMT SOP (Kansas University Cancer Center Bone Marrow Transplant Standard Operation Procedures) with chemo-sensitive/marrow negative disease.
Patients planning to harvest and hold may also be included as long as above criteria are met.

Exclusion Criteria

Pregnancy
Zubrod performance status greater than 2
Life expectancy is severely limited by concomitant illness.
Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation
Symptomatic pulmonary disease precluding transplantation
Serum creatinine greater than 1.8 mg/dL
Serum bilirubin greater than 2 X upper limit of normal, SGPT (serum glutamate pyruvate transaminase) greater than 3 times upper limit of normal
Evidence of chronic active hepatitis or cirrhosis
Unable to sign informed consent.
Allergy to Rituximab

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00856245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.