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 - Full Text View

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 (GOTEL-FL1LC)

This study is currently recruiting participants.

Verified by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas, July 2008

First Received: July 25, 2008 No Changes Posted

Sponsor:	Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Information provided by:	Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
ClinicalTrials.gov Identifier:	NCT00722930

Purpose

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	Intervention	Phase
Follicular Lymphoma	Drug: Y90 Ibritumomab Tiuxetan	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Ibritumomab tiuxetan

U.S. FDA Resources

Further study details as provided by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas:

Primary Outcome Measures:

CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease [ Time Frame: 12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective clinical response rate (complete + partial). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Response conversion rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Incidence of complete molecular responses [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Response duration [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Event-free survival. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Time to salvage therapy [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Lymphoma-free or specific cause-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Toxicity profile and safety of the consolidation [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Consolidation with Y90 Ibritumomab Tiuxetan: Experimental 1. Consolidation with Y90 Ibritumomab Tiuxetan	Drug: Y90 Ibritumomab Tiuxetan Consolidation with Y90 Ibritumomab Tiuxetan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722930

Contacts

Contact: Mariano Provencio, MD	+34-91-344-57-60	mprovenciop@yahoo.es
Contact: Sandra Cerdeira, Secretary	34 91 3445131	secretariatecnica@grupolinfomas.es

Locations

Spain
Hospital Virgen de las Nieves	Active, not recruiting
Granada, Spain
Clínica Ruber Internacional	Active, not recruiting
Madrid, Spain
Clinia Puerta de Hierro	Recruiting
Madrid, Spain
Principal Investigator: Mariano Provencio, MD
Complejo Hospitalario de Pontevedra	Active, not recruiting
Pontevedra, Spain
Hospital Universitario Virgen Macarena	Active, not recruiting
Sevilla, Spain
Hospital Virgen de la Salud de Toledo	Active, not recruiting
Toledo, Spain
Hospital Universitario La Fe	Active, not recruiting
Valencia, Spain
Spain, Malaga
Hospital Virgen de la Victoria	Active, not recruiting
Málaga, Malaga, Spain
Spain, San Sebastián
Instituto Oncológico San Sebastián	Active, not recruiting
Donostia, San Sebastián, Spain
Spain, Santa Cruz de Tenerife
Hospital Universitario de Canarias	Active, not recruiting
La Laguna, Santa Cruz de Tenerife, Spain
Spain, Tarragona
Hospital Sant Joan de Reus	Active, not recruiting
Reus, Tarragona, Spain

Sponsors and Collaborators

Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

Investigators

Principal Investigator:

Mariano Provencio, MD

Clínica Puerta de Hierro

More Information

No publications provided

Responsible Party:	Clínica Puerta de Hierro, Servicio de Oncología Médica ( Dr. Mariano Provencio )
Study ID Numbers:	GOTEL-FL1LC-0701, Eudra-CT 2007-003091-19
Study First Received:	July 25, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00722930 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas:

Follicular Lymphoma
High-risk FLIPI
R-CHOP
GOTEL
Partial

Complete
Response
R-CHOP
Induction
Chemotherapy

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Lymphoma, Follicular
Pharmacologic Actions

Antibodies, Monoclonal
Lymphatic Diseases
Neoplasms
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010