Clinical trial · Interventional
Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma
A Pilot Phase II Study Of Sequential Treatment With Chemotherapy, Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation in Patients With Follicular Lymphoma
NCT01130194CI-TRIAL-00014484MasterPlancompletedPhase 2ClinicalTrials.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)
Follicular lymphoma has historically been considered an incurable lymphoma. By combining multiple effective treatments, the investigators believe that prolonged disease-free survival is achievable in this disease. The investigators goal is to have at least 60-70% of our patients in first continuous complete remission 15 years from initiation of treatment.
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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of treatment modalities | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- C-MOPP-R chemotherapy, 6 cycles Peripheral blood stem cell mobilization Radioimmunotherapy Autologous Hematopoietic Stem Cell Transplantation
- interventionNames
- Other: Combination of treatment modalities
Primary outcomes (1)
- measure
- Disease-free survival percentage(intention to treat)
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Incidence of second malignancies
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years of age * Follicular lymphoma, newly diagnosed or previously treated but no more than 2 previous regimens * Relapse of disease must be greater than 6 months after last chemotherapy * Stages II, III or IV * Eastern Cooperative Group (ECOG) performance status of 0 or 1. If ECOG 2-4, poor performance must by due to lymphoma as judged by study investigator. * Patient signed written informed consent * Adequate renal function defined as a glomerular filtration rate (GFR) \> 60 ml/min * Adequate blood counts (absolute neutrophil count ≥ 1,500, platelets ≥100,000), unless low due to lymphomatous involvement of the bone marrow. * No known allergies to the chemotherapeutic agents * No other major disabling co morbidities * Adequate pulmonary function, defined as corrected DLCO greater than 70% of predicted and FEV1 (forced expiratory volume in one second, a test of respiratory function) greater than 50% of predicted. * Adequate hepatic function as assessed by study investigator * Adequate cardiac function, defined as baseline MUGA (Multiple gated acquisition, a test of heart function) \>50% Exclusion Criteria: * Stage I follicular lymphoma * ECOG performance status ≥ 2, unless due to lymphoma * Patient refuses to sign written informed consent * Poor renal function defined as GFR \<60ml/min * Abnormal liver function as assessed by study investigator * Poor bone marrow reserve (absolute neutrophil count \<1,500 and/or platelets \< 100,000) not attributable to lymphomatous involvement of the bone marrow. * Hypersensitivity to the chemotherapeutic agents * Major disabling co morbidities like uncontrolled severe HTN (hypertension), active coronary artery disease, liver cirrhosis. * Previously diagnosed malignancy other than basal or squamous cell carcinoma of the skin diagnosed \<5 years prior. * Central nervous system disease * History of advanced cardiac disease (Active angina, Congestive heart failure with a LVEF (left ventricular ejection fraction) \<50%).
References
Publications (1)
- RESULTFesler MJ, Osman M, Glauber J, Petruska PJ. C-MOPP: Results of a Forgotten Regimen in the Era of Rituximab and PET. Blood (ASH Annual Meeting Abstracts 2009) #4577.