GOTEL-FL1LC: 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

Sponsor

Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas (Other)

Overall Status

Unknown status

CT.gov ID

NCT00722930

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma	Drug: Y90 Ibritumomab Tiuxetan	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2008

Anticipated Primary Completion Date :

Apr 1, 2011

Anticipated Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. Consolidation with Y90 Ibritumomab Tiuxetan 1. Consolidation with Y90 Ibritumomab Tiuxetan	Drug: Y90 Ibritumomab Tiuxetan Consolidation with Y90 Ibritumomab Tiuxetan

Arm

Intervention/Treatment

Experimental: 1. Consolidation with Y90 Ibritumomab Tiuxetan

1. Consolidation with Y90 Ibritumomab Tiuxetan

Drug: Y90 Ibritumomab Tiuxetan

Consolidation with Y90 Ibritumomab Tiuxetan

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Objective clinical response rate (complete + partial). [3 months]
Response conversion rate [3 months]
Incidence of complete molecular responses [3 months]
Response duration [36 months]
Event-free survival. [36 months]
Progression-free survival [36 months]
Time to salvage therapy [36 months]
Lymphoma-free or specific cause-free survival [36 months]
Overall survival [60 months]
Toxicity profile and safety of the consolidation [60 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Virgen de la Victoria	Málaga	Malaga	Spain
2	Instituto Oncológico San Sebastián	Donostia	San Sebastián	Spain
3	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife	Spain
4	Hospital Sant Joan de Reus	Reus	Tarragona	Spain
5	Hospital Virgen de las Nieves	Granada		Spain
6	Clinia Puerta de Hierro	Madrid		Spain
7	Clínica Ruber Internacional	Madrid		Spain
8	Complejo Hospitalario de Pontevedra	Pontevedra		Spain
9	Hospital Universitario Virgen Macarena	Sevilla		Spain
10	Hospital Virgen de la Salud de Toledo	Toledo		Spain
11	Hospital Universitario La Fe	Valencia		Spain