Clinical trial · Interventional
Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma
Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy
NCT00722930CI-TRIAL-00001623GOTEL-FL1LCunknownPhase 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)
To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy
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 |
|---|---|---|---|
| Y90 Ibritumomab Tiuxetan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1. Consolidation with Y90 Ibritumomab Tiuxetan
- description
- 1\. Consolidation with Y90 Ibritumomab Tiuxetan
- interventionNames
- Drug: Y90 Ibritumomab Tiuxetan
Primary outcomes (1)
- measure
- CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease
- timeFrame
- 12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter
Secondary outcomes (10)
- measure
- Objective clinical response rate (complete + partial).
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Signature of the written informed consent by the subject or his/her legal representative before initiation of any trial specific procedure.
* Patients older than 18.
* Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO classification.
* High-risk patients according to FLIPI before initiation of induction chemotherapy.
* Stage II-IV prior to initiation of induction treatment, or any stage in patients with grade 3 follicular lymphoma.
* Complete or partial response to the induction scheme.
* ECOG scale performance status 0 - 2.
* Life expectancy greater than 3 months.
* In women of childbearing age, use of a reliable contraceptive method.
* A suitable bone marrow reserve:
* Lower than 25% Bone marrow infiltration by lymphoma.
* Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3
* Suitable hepatic, renal and cardiac function:
* creatinine \<2,5 x UNL (upper normality limit).
* bilirubin or ALT/AST \< 2,5 x UNL
Exclusion Criteria:
* Patients with no objective clinical response to induction chemotherapy.
* \> 25% bone marrow infiltration following induction chemotherapy.
* Platelets \< 100,000 before radioimmunotherapy.
* Severe and/or uncontrolled concomitant disease:
* Hepatic, renal, cardiovascular, neurological or metabolic disease.
* Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of myocardial infarction or angor, or major ventricular arrhythmia.
* Positive regarding HBV, HCV, HIV.
* Active acute or chronic infection.
* Social, psychic or geographic disability to satisfy any of the treatment schemes.
* Pregnant and/or breastfeeding women, or adult patients of childbearing age who are not using a safe birth control device throughout the study treatment and at least 12 months thereafter.
* Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other anthracyclines, cytarabine).References
Publications (0)
Data not yet available
No reference posted for this study.