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

Summary

The goal of this clinical research study is to compare chemotherapy given with rituximab to chemotherapy followed by rituximab. The safety of both treatment schedules will be studied. Laboratory tests of genetic changes in blood and bone marrow before and during the study will also be monitored.

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.

Sponsors & Collaborators

• Genentech, Inc.

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Nathan Fowler, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

76 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1998-03-16

Primary Completion

2017-08-24

Completion

2017-08-24

FDA Drug

Yes

Countries

• United States

Study Locations