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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Follicular Lymphoma

Keywords

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Follicular Lymphoma High-risk FLIPI R-CHOP GOTEL Partial Complete Response Induction Chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Consolidation with Y90 Ibritumomab Tiuxetan

1\. Consolidation with Y90 Ibritumomab Tiuxetan

Group Type EXPERIMENTAL

Y90 Ibritumomab Tiuxetan

Intervention Type DRUG

Consolidation with Y90 Ibritumomab Tiuxetan

Interventions

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Y90 Ibritumomab Tiuxetan

Consolidation with Y90 Ibritumomab Tiuxetan

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Clínica Puerta de Hierro, Servicio de Oncología Médica

Principal Investigators

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Mariano Provencio, MD

Role: PRINCIPAL_INVESTIGATOR

Clínica Puerta de Hierro

Locations

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