Clinical trial NCT00722930: 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
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Follicular Lymphoma
Keywords: Follicular Lymphoma
High-risk FLIPI
R-CHOP
GOTEL
Partial
Complete
Response
Induction
Chemotherapy
Lead sponsor: Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Sponsor class: OTHER
First posted: 2008-07-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
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:
measure: Objective clinical response rate (complete + partial).
timeFrame: 3 months
measure: Response conversion rate
timeFrame: 3 months
measure: Incidence of complete molecular responses
timeFrame: 3 months
measure: Response duration
timeFrame: 36 months
measure: Event-free survival.
timeFrame: 36 months
measure: Progression-free survival
timeFrame: 36 months
measure: Time to salvage therapy
timeFrame: 36 months
measure: Lymphoma-free or specific cause-free survival
timeFrame: 36 months
measure: Overall survival
timeFrame: 60 months
measure: Toxicity profile and safety of the consolidation
timeFrame: 60 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
state: Malaga
city: Donostia
country: Spain
facility: Instituto Oncológico San Sebastián
state: San Sebastián
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
city: Reus
country: Spain
facility: Hospital Sant Joan de Reus
state: Tarragona
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Madrid
country: Spain
facility: Clinia Puerta de Hierro
city: Madrid
country: Spain
facility: Clínica Ruber Internacional
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud de Toledo
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: Clínica Puerta de Hierro
name: Mariano Provencio, MD
role: PRINCIPAL_INVESTIGATOR
References: