Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

March 16, 1998

Primary Completion Date

August 24, 2017

Study Completion Date

August 24, 2017

Conditions
Lymphoma
Interventions
DRUG

Fludarabine

Group 1= 25 mg/m\^2 IV over 15 min. Days 2 through 4 for 8 Cycles; Group 2 = 25 mg/m\^2 IV over 15 min. Days 1 through 3 for 8 Cycles.

DRUG

Novantrone

Group 1 = 10 mg/m\^2 IV over 15 min. Day 2 for 8 Cycles; Group 2 = 10 mg/m\^2 IV over 15 min. Day 1 for 8 Cycles; Group 3 = 10 mg/m\^2 IV over 15 min. Day 2 of 3rd Sequence.

DRUG

Decadron

Group 1 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 2 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 3 = 40 mg PO Days 1 through 4 of 1st Sequence; After Completion of 3 Sequences, Days 1 through 3 Every Month for 1 Year.

DRUG

Rituximab

Group 1 = 375 mg/m\^2 IV Days 1 through 8 of Course 1, then Day 1 Only of Cycles 2 through 5; Group 2 = 4 Months after IFN Starts, 375 mg/m\^2 IV Once Per Month for 6 Months; Group 3 = 375 mg/m\^2 IV Days 1 through 8 of 1st Sequence; 375 mg/m\^2 IV Days 1 through 8 of 3rd Sequence.

DRUG

Interferon

Group 1 = After Completion of Fludarabine, Novantrone, \& Rituximab, IFN 3 mcg/ml/m\^2 SQ Days 1 through 14 Each Month for 1 year; Group 2 = After Completion of Fludarabine \& Novantrone, IFN 3 mcg/ml/m\^2 SQ Days 1 through 14 Each Month for 1 year; Group 3 = After Completion of 3 Sequences, IFN 3 mcg/ml/m\^2 SQ Days 1 through 14 Each Month for 1 year.

DRUG

Doxorubicin

25 mg/m\^2 IV Days 2 \& 3 of 1st Sequence.

DRUG

Vincristine

.7 mg/m\^2 IV Days 2 \& 3 of 1st Sequence; 1.4 mg/m\^2 IV Day 2 of 3rd Sequence.

DRUG

Bleomycin

5 unit/m\^2 IV Days 2 \& 3 of 1st Sequence.

DRUG

Cyclophosphamide

750 mg/m\^2 IV Day 2 of 1st Sequence.

DRUG

Etoposide

40 mg/m\^2 IV Days 1 through 4 of 2nd Sequence.

DRUG

Cisplatin

25 mg/m\^2 IV Days 1 through 4 of 2nd Sequence

DRUG

Ara-C

1.5 gm/m\^2 IV Day 5 of 2nd Sequence.

DRUG

Methyl-Prednisolone

500 mg IV Days 1 through 5 of 2nd Sequence.

DRUG

Procarbazine

100 mg/m\^2 PO Days 2 through 11 of 3rd Sequence.

DRUG

Prednisone

100 mg PO Days 1 through 5 of 3rd Sequence.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER