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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00577993
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 76 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    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.
  • Novantrone — DRUG
    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.
  • Decadron — DRUG
    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.
  • Rituximab — DRUG
    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.
  • Interferon — DRUG
    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.
  • Doxorubicin — DRUG
    25 mg/m\^2 IV Days 2 \& 3 of 1st Sequence.
  • Vincristine — DRUG
    .7 mg/m\^2 IV Days 2 \& 3 of 1st Sequence; 1.4 mg/m\^2 IV Day 2 of 3rd Sequence.
  • Bleomycin — DRUG
    5 unit/m\^2 IV Days 2 \& 3 of 1st Sequence.
  • Cyclophosphamide — DRUG
    750 mg/m\^2 IV Day 2 of 1st Sequence.
  • Etoposide — DRUG
    40 mg/m\^2 IV Days 1 through 4 of 2nd Sequence.
  • Cisplatin — DRUG
    25 mg/m\^2 IV Days 1 through 4 of 2nd Sequence
  • Ara-C — DRUG
    1.5 gm/m\^2 IV Day 5 of 2nd Sequence.
  • Methyl-Prednisolone — DRUG
    500 mg IV Days 1 through 5 of 2nd Sequence.
  • Procarbazine — DRUG
    100 mg/m\^2 PO Days 2 through 11 of 3rd Sequence.
  • Prednisone — DRUG
    100 mg PO Days 1 through 5 of 3rd Sequence.

Study Details

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.

Key Dates

Start date
Mar 16, 1998
Status verified
Oct 2020
Primary completion
Aug 24, 2017
Completion
Aug 24, 2017

Study Design

Enrollment
210 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1: FND + Rituximab Followed by Interferon
    Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon
  • Active Comparator: 2: FND Followed by Interferon & Rituximab
    Fludarabine/Novantrone/Decadron Followed by Interferon \& Rituximab
  • Active Comparator: 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
    Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon

Primary Outcome Measure

Number of Participants With Overall Survival (10 Years) by Treatment [ Time Frame: 10 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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