Clinical trial · Interventional
Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma
Role of Rituximab Containing Salvage Chemotherapy and in Vivo Purging in Obtaining PCR Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma or Transplant Eligible Mantle Cell Lymphoma
NCT00856245CI-TRIAL-00027855completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkins Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Rituximab
- description
- 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.
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- Rate of PCR Negativity
- timeFrame
- up to 7 days
- description
- Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.