NCT00499018

Dose Dense Chemotherapy + Rituximab +/-Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cell in Diffuse Large B-Cell Lymphoma

A Randomised Multicentric Phase III Study for the Treatment of Young Patients With High Risk (IPI 2-3) Diffuse Large B-Cell Lymphoma. Dose Dense Chemotherapy + Rituximab +/- Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cells.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 399 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to define an improvement in patients randomized in four different arms: Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are different in dose dense chemotherapy + Rituximab with or without intensified high dose chemoimmunotherapy and support of peripheral autologous stem cells.

Conditions

• Diffuse Large B-Cell Lymphoma
• IPI≥2

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2 day 1
DRUG	Ciclofosfamide	1200 mg/m2 day 1
DRUG	Doxorubicina	70 mg/m2 day 1
DRUG	Vincristina	1,4 mg/m2 (max 2 mg) day 1
DRUG	Prednisone	100 mg day g 1-5
DRUG	Pegfilgrastim	6 mg day +1
DRUG	Mitoxantrone	8 mg/m2/days 1-3
DRUG	ARA-C	2000 mg/m2/12h day 1 - 3
DRUG	Lenograstim	5 μg/Kg/days +2
DRUG	BCNU	300 mg/m2 day -7
DRUG	ARA-C	200 mg/m2/12 days -6,-5,-4,-3
DRUG	VP-16	100 mg/m2/12h days -6,-5,-4,-3
PROCEDURE	ASCT	PBSC Reinfusion
DRUG	Ciclofosfamide	750 mg/m2 day 1
DRUG	Doxorubicina	50 mg/m2 day 1
DRUG	Vincristina	1,4 mg/m2 (max 2 mg) day 1

Timeline

• Start date: 2006-01-01
• Primary completion: 2011-06-01
• Completion: 2013-09-01
• First posted: 2007-07-11
• Last updated: 2011-02-15

Locations

75 sites across 1 country: Italy