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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361191
|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 Princesa|
|Madrid, Spain, 28006|
|Hospital Universitario Gregorio Marañon|
|Madrid, Spain, 28007|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|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|