Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Diffuse Large B-cell LymphomaFollicular Grade 3B Lymphoma
Interventions
DRUG

R-MEGACHOP

"* 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)."

Trial Locations (19)

11407

Hospital de Jerez, Jerez de la Frontera

15706

Hospital Clínico Univ. de Santiago, Santiago de Compostela

23006

Complejo Hospitalario de Jaén, Jaén

28006

Hospital Universitario La Princesa, Madrid

28007

Hospital Universitario Gregorio Marañon, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

30008

Hospital Univ. Morales Meseguer, Murcia

31008

Clínica Universitaria de Navarra, Pamplona

37007

Hospital Universitario de Salamanca, Salamanca

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

39008

Hospital Universitario Marques de Valdecilla, Santander

40002

Hospital General de Segovia, Segovia

47010

Hospital Universitario Río Hortega, Valladolid

49022

Hospital Universitario Virgen de la Concha, Zamora

50009

Hospital Clínico Lozano Blesa, Zaragoza

08907

ICO- Hospital Duran i Reynals, L'Hospitalet de Llobregat

07014

Hospital Univ. Son Dureta, Palma de Mallorca

07198

Hospital Son Llàtzer, Palma de Mallorca

All Listed Sponsors
lead

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

NCT01361191 - Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma | Biotech Hunter | Biotech Hunter