Spots Global Cancer Trial Database for Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: 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 ID: NCT01361191
Interventions
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ICO- Hospital Duran i Reynals, Hospitalet de Llobregat, Barcelona, Spain
Hospital de Jerez, Jerez de la Frontera, Cádiz, Spain
Hospital Clínico Univ. de Santiago, Santiago de Compostela, Galicia, Spain
Hospital Univ. Son Dureta, Palma de Mallorca, Mallorca, Spain
Hospital Son Llàtzer, Palma de Mallorca, Mallorca, Spain
Hospital Universitario de Canarias, La Laguna, Santa Cruz de Tenerife, Spain
Complejo Hospitalario de Jaén, Jaén, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Univ. Morales Meseguer, Murcia, , Spain
Clínica Universitaria de Navarra, Pamplona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital General de Segovia, Segovia, , Spain
Hospital Universitario Río Hortega, Valladolid, , Spain
Hospital Universitario Virgen de la Concha, Zamora, , Spain
Hospital Clínico Lozano Blesa, Zaragoza, , Spain
Contact Details
Name: José Fuster, MD
Affiliation: Son Dureta Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos Grande, MD
Affiliation: 12 Octubre Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: José Luís Bello, MD
Affiliation: Santiago Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Maria José Ramirez, MD
Affiliation: Jerez Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos Panizo, MD
Affiliation: Navarra Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Elena Pérez, MD
Affiliation: Morales i Meseguer Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jorge Gayoso, MD
Affiliation: Gregorio Marañon Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Reyes Arranz, MD
Affiliation: Princesa Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Eulogio Conde, MD
Affiliation: Marques de Valdecilla Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Eva González, MD
Affiliation: Duran i Reynals Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Miguel Canales, MD
Affiliation: La Paz Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Joan Bargay, MD
Affiliation: Son Llatzer Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Miguel T. Hernández, MD
Affiliation: Canarias University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Alcala, MD
Affiliation: Jaen Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Luis Palomera, MD
Affiliation: Lozano Blesa Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: José Queizán, MD
Affiliation: Segovia Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: María José Peñarrubia, MD
Affiliation: Río Hortega Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Alejandro Martín, MD
Affiliation: Virgen de la Concha Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Sílvia Fernández, MD
Affiliation: León Hospital
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
