Clinical trial NCT01361191: Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
Official title: Early Treatment Stratification Based on PET Scan Response to R-MEGACHOP Followed by R-MEGACHOP or R-IFE Plus Peripheral Autologous Stem Cell Transplant (PBSCT) in Patients With Poor Prognosis DLBCL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Follicular Grade 3B Lymphoma
Keywords: DLBCL
PET
IPI
R-MegaCHOP
Autologous stem cell transplantation
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the event free survival at three years in patients with diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP without transplant.

Detailed description: In addition to the above:

* To evaluate the overall survival after three years.
* To determine the rate of global responses and complete remissions, uncertain and partial.
* To determine the duration of the complete response after the treatment termination.
* To carry out an exploratory follow up of the event free survival and the overall survival at 5 years.
* To evaluate the treatment toxicity according CTC criteria (version 3.0) of the National Cancer Institute (NCI).
* To asses the role of PET in the disease stage and response evaluation compared to CAT.
* To identify the predictable response factors after 6 cycles of treatment with R-MegaCHOP administrated every 21 days; or 3 cycles of R-MegaCHOP, followed by IFE+TAPH in patients with DLBCL of severe prognosis.
* To evaluate the therapeutic fulfillment of the R-MegaCHOP and R+IFE cycles of treatment and/or R-IFE in reference with delays with the cycles administration and reductions of the chemotherapy dose (planned dose administrated in the planned term).

Eligibility criteria: Inclusion Criteria:

1. follicular lymphoma grade III diagnosed patients, diffuse large B-cell lymphoma, histologically confirmed with CD20+
2. aged between 18 and 65 years. Patients aged from 65 to 70 years can be included according to the investigator's criteria regarding the patients' global health status and the absence of excluding comorbidity.
3. IPI adjusted to the age over 1 or a-IPI and beta2-microglobulin equal or higher than 3 mg/dl 3. Punctuation in the ECOG grade from 0 to 4
4. Life expectancy over 12 weeks
5. Written informed consent form 6. New diagnosed patient without any previous treatment

Exclusion Criteria:

1. Existence of severe cardiac, pulmonary, neurologic, psychiatric and metabolic diseases not caused by the lymphoma.
2. uncontrolled high blood pressure (diastolic pressure in rest \> 115 mmHg)
3. Altered hepatic function (bilirubin or AST/ALT superior or equal at 2 times the superior limit of normality) or renal (creatinine equal or superior at 1.5 times the superior limit of normality) not caused by the lymphoma.
4. other malignant neoplasias along the past 5 years, except skin tumors, excluded melanoma or carcinoma in situ of cervix
5. patients positive for HIV
6. patients with transformed follicular lymphoma
7. pregnant women or in nursing; women of childbearing age who do not use an adequate contraceptive method before being included in the study
8. ventricular ejection fraction inferior to 50%
9. patients with severe psychiatric diseases which can interfere with their ability for understanding the study (including alcoholism or drug addiction)

Primary outcomes:
measure: Event free survival at 3y in pat with DLBCL with a-IPI>1 or a-IPI=1 and ß2 µglobulin>=3mg/dl in pat PET+ after 3cycles of R-MegaCHOP and early rescue with R-IFE+TAPH or in pat PET- after 3cycles R-MegaCHOP followed by 3cycles of R-MegaCHOP without TAPH
timeFrame: 5 years follow-up
Secondary outcomes:
measure: To evaluate the overall survival after three years. Further secondary outcomes as described in study summary.
timeFrame: 5 years follow-up
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: ICO- Hospital Duran i Reynals
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
state: Cádiz
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Univ. de Santiago
state: Galicia
city: Palma de Mallorca
country: Spain
facility: Hospital Univ. Son Dureta
state: Mallorca
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Mallorca
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital Univ. Morales Meseguer
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Zamora
country: Spain
facility: Hospital Universitario Virgen de la Concha
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Son Dureta Hospital
name: José Fuster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 12 Octubre Hospital
name: Carlos Grande, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santiago Hospital
name: José Luís Bello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jerez Hospital
name: Maria José Ramirez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Navarra Clinic
name: Carlos Panizo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Morales i Meseguer Hospital
name: Elena Pérez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gregorio Marañon Hospital
name: Jorge Gayoso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princesa Hospital
name: Reyes Arranz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marques de Valdecilla Hospital
name: Eulogio Conde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duran i Reynals Hospital
name: Eva González, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Paz Hospital
name: Miguel Canales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Son Llatzer Hospital
name: Joan Bargay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canarias University Hospital
name: Miguel T. Hernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jaen Hospital
name: Antonio Alcala, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lozano Blesa Clinic
name: Luis Palomera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Segovia Hospital
name: José Queizán, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Río Hortega Hospital
name: María José Peñarrubia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virgen de la Concha Hospital
name: Alejandro Martín, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: León Hospital
name: Sílvia Fernández, MD
role: PRINCIPAL_INVESTIGATOR
References: