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

Follicular Lymphoma Clinical Trial

— GOTEL-FL1LC  

Official title:

Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00722930
• Other study ID #: GOTEL-FL1LC-0701
• Secondary ID: Eudra-CT 2007-00
• Status: Recruiting
• Phase: Phase 2
• First received: July 25, 2008
• Last updated: July 25, 2008
• Start date: April 2008
• Est. completion date: April 2013

Study information

• Verified date: July 2008
• Source: Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
• Contact: Mariano Provencio, MD
• Phone: +34-91-344-57-60
• Email: mprovenciop[@]yahoo.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: April 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Y90 Ibritumomab Tiuxetan
Consolidation with Y90 Ibritumomab Tiuxetan

Locations

Country	Name	City	State
Spain	Instituto Oncológico San Sebastián	Donostia	San Sebastián
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife
Spain	Clinia Puerta de Hierro	Madrid
Spain	Clínica Ruber Internacional	Madrid
Spain	Hospital Virgen de la Victoria	Málaga	Malaga
Spain	Complejo Hospitalario de Pontevedra	Pontevedra
Spain	Hospital Sant Joan de Reus	Reus	Tarragona
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Virgen de la Salud de Toledo	Toledo
Spain	Hospital Universitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease		12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter	No
Secondary	Objective clinical response rate (complete + partial).		3 months	No
Secondary	Response conversion rate		3 months	No
Secondary	Incidence of complete molecular responses		3 months	No
Secondary	Response duration		36 months	No
Secondary	Event-free survival.		36 months	No
Secondary	Progression-free survival		36 months	No
Secondary	Time to salvage therapy		36 months	No
Secondary	Lymphoma-free or specific cause-free survival		36 months	No
Secondary	Overall survival		60 months	No
Secondary	Toxicity profile and safety of the consolidation		60 months	No