Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
- Conditions
- Follicular Grade 3B LymphomaDiffuse Large B-cell Lymphoma
- Registration Number
- NCT01361191
- Lead Sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- follicular lymphoma grade III diagnosed patients, diffuse large B-cell lymphoma, histologically confirmed with CD20+
- 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.
- 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
- Life expectancy over 12 weeks
- Written informed consent form 6. New diagnosed patient without any previous treatment
- Existence of severe cardiac, pulmonary, neurologic, psychiatric and metabolic diseases not caused by the lymphoma.
- uncontrolled high blood pressure (diastolic pressure in rest > 115 mmHg)
- 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.
- other malignant neoplasias along the past 5 years, except skin tumors, excluded melanoma or carcinoma in situ of cervix
- patients positive for HIV
- patients with transformed follicular lymphoma
- pregnant women or in nursing; women of childbearing age who do not use an adequate contraceptive method before being included in the study
- ventricular ejection fraction inferior to 50%
- patients with severe psychiatric diseases which can interfere with their ability for understanding the study (including alcoholism or drug addiction)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 5 years follow-up
- Secondary Outcome Measures
Name Time Method To evaluate the overall survival after three years. Further secondary outcomes as described in study summary. 5 years follow-up
Trial Locations
- Locations (19)
ICO- Hospital Duran i Reynals
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Clínico Univ. de Santiago
🇪🇸Santiago de Compostela, Galicia, Spain
Hospital Clínico Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Univ. Son Dureta
🇪🇸Palma de Mallorca, Mallorca, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Son Llàtzer
🇪🇸Palma de Mallorca, Mallorca, Spain
Hospital de Jerez
🇪🇸Jerez de la Frontera, Cádiz, Spain
Hospital Univ. Morales Meseguer
🇪🇸Murcia, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital General de Segovia
🇪🇸Segovia, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Santa Cruz de Tenerife, Spain
Hospital Universitario Río Hortega
🇪🇸Valladolid, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario Virgen de la Concha
🇪🇸Zamora, Spain