Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

March 31, 2018

Study Completion Date

March 31, 2018

Conditions
Diffuse Large B-cell Lymphoma
Interventions
DRUG

Valproate

Valproate is given in escalating doses to establish maximum tolerable dose when given together with standard treatment in patients with diffuse large B-cell lymphoma; this is the phase I part of the study. When maximum tolerable dose is established, this dose will be given to remaining patients in the phase II part of the study.

DRUG

Rituximab

Vill be given intravenously, 375 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.

DRUG

Cyclophosphamide

Vill be given intravenously, 750 mg/m2, every second or third week depending on cycle length (14 or 21 days) for a total of 6 cycles.

DRUG

Doxorubicin

Vill be given intravenously, 50 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.

DRUG

Vincristine

Vill be given intravenously, 1.2 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.

DRUG

Prednisone

Vill be given orally, 50 mg/m2, day 1-5 every cycle, for a total of 6 cycles.

Trial Locations (1)

221 85

Skåne University Hospital, Dept. of Oncology, Lund

All Listed Sponsors
collaborator

Valcuria

UNKNOWN

lead

Lund University Hospital

OTHER

NCT01622439 - Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma | Biotech Hunter | Biotech Hunter