Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma (R-MEGACHOP)
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.
Diffuse Large B-cell Lymphoma
Follicular Grade 3B Lymphoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 [ Time Frame: 5 years follow-up ] [ Designated as safety issue: Yes ]
- To evaluate the overall survival after three years. Further secondary outcomes as described in study summary. [ Time Frame: 5 years follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
- If PET + after third cycle: 2 cycles of R-IFE followed by PBSCT
- If PET - after third cycle: 3 additional cycles of R-MegaCHOP - R-MegaCHOP: cycles every 21 days RITUXIMAB Dosage: 375mg/m2, IV, day 1 CICLOPHOSPHAMIDE Dosage: 1500 mg/m2, IV, day 1 DOXORUBICIN Dosage: 65 mg/m2, IV, day 1 VINCRISTIN: Dosage 1.4 mg/m2 (max. 2.0 mg/m2, IV, day 1 PREDNISONE Dosage: 60 mg/m2, IV, day 1-5
R-IFE: 2 cycles every 21 days:
IFOSFAMIDE Dosage: continuous perfusion of 10 gr/m2/iv during 72 hours. Therefore, 3.33 gr/m2/corporal weight 24 hours day +1, +2 and +3.
ETOPOSIDE Dosage: total 900 mg/m2, IV, which is 150 mg/m2 during 12 hours (days +1, +2 and +3).
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).
|ICO- Hospital Duran i Reynals|
|Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Hospital de Jerez|
|Jerez de la Frontera, Cádiz, Spain, 11407|
|Hospital Clínico Univ. de Santiago|
|Santiago de Compostela, Galicia, Spain, 15706|
|Hospital Son Llàtzer|
|Palma de Mallorca, Mallorca, Spain, 07198|
|Hospital Univ. Son Dureta|
|Palma de Mallorca, Mallorca, Spain, 07014|
|Hospital Universitario de Canarias|
|La Laguna, Santa Cruz de Tenerife, Spain, 38320|
|Complejo Hospitalario de Jaén|
|Jaén, Spain, 23006|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital Universitario Gregorio Marañon|
|Madrid, Spain, 28007|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Hospital Universitario La Princesa|
|Madrid, Spain, 28006|
|Hospital Univ. Morales Meseguer|
|Murcia, Spain, 30008|
|Clínica Universitaria de Navarra|
|Pamplona, Spain, 31008|
|Hospital Universitario de Salamanca|
|Salamanca, Spain, 37007|
|Hospital Universitario Marques de Valdecilla|
|Santander, Spain, 39008|
|Hospital General de Segovia|
|Segovia, Spain, 40002|
|Hospital Universitario Río Hortega|
|Valladolid, Spain, 47010|
|Hospital Universitario Virgen de la Concha|
|Zamora, Spain, 49022|
|Hospital Clínico Lozano Blesa|
|Zaragoza, Spain, 50009|
|Principal Investigator:||José Fuster, MD||Son Dureta Hospital|
|Principal Investigator:||Carlos Grande, MD||12 Octubre Hospital|
|Principal Investigator:||José Luís Bello, MD||Santiago Hospital|
|Principal Investigator:||Maria José Ramirez, MD||Jerez Hospital|
|Principal Investigator:||Carlos Panizo, MD||Navarra Clinic|
|Principal Investigator:||Elena Pérez, MD||Morales i Meseguer Hospital|
|Principal Investigator:||Jorge Gayoso, MD||Gregorio Marañon Hospital|
|Principal Investigator:||Reyes Arranz, MD||Princesa Hospital|
|Principal Investigator:||Eulogio Conde, MD||Marques de Valdecilla Hospital|
|Principal Investigator:||Eva González, MD||Duran i Reynals Hospital|
|Principal Investigator:||Miguel Canales, MD||La Paz Hospital|
|Principal Investigator:||Joan Bargay, MD||Son Llatzer Hospital|
|Principal Investigator:||Miguel T. Hernández, MD||Canarias University Hospital|
|Principal Investigator:||Antonio Alcala, MD||Jaen Hospital|
|Principal Investigator:||Luis Palomera, MD||Lozano Blesa Clinic|
|Principal Investigator:||José Queizán, MD||Segovia Hospital|
|Principal Investigator:||María José Peñarrubia, MD||Río Hortega Hospital|
|Principal Investigator:||Alejandro Martín, MD||Virgen de la Concha Hospital|
|Principal Investigator:||Sílvia Fernández, MD||León Hospital|