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

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.

Conditions

• Diffuse Large B-cell Lymphoma
• Follicular 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).

Sponsors & Collaborators

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

  lead OTHER

Principal Investigators

• José Fuster, MD · Son Dureta Hospital

• Carlos Grande, MD · 12 Octubre Hospital

• José Luís Bello, MD · Santiago Hospital

• Maria José Ramirez, MD · Jerez Hospital

• Carlos Panizo, MD · Navarra Clinic

• Elena Pérez, MD · Morales i Meseguer Hospital

• Jorge Gayoso, MD · Gregorio Marañon Hospital

• Reyes Arranz, MD · Princesa Hospital

• Eulogio Conde, MD · Marques de Valdecilla Hospital

• Eva González, MD · Duran i Reynals Hospital

• Miguel Canales, MD · La Paz Hospital

• Joan Bargay, MD · Son Llatzer Hospital

• Miguel T. Hernández, MD · Canarias University Hospital

• Antonio Alcala, MD · Jaen Hospital

• Luis Palomera, MD · Lozano Blesa Clinic

• José Queizán, MD · Segovia Hospital

• María José Peñarrubia, MD · Río Hortega Hospital

• Alejandro Martín, MD · Virgen de la Concha Hospital

• Sílvia Fernández, MD · León Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2012-09-30

Completion

2012-09-30

Countries

• Spain

Study Locations