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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577993
First Posted: December 20, 2007
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention Phase
Lymphoma Drug: Fludarabine Drug: Novantrone Drug: Decadron Drug: Rituximab Drug: Interferon Drug: Doxorubicin Drug: Vincristine Drug: Bleomycin Drug: Cyclophosphamide Drug: Etoposide Drug: Cisplatin Drug: Ara-C Drug: Methyl-Prednisolone Drug: Procarbazine Drug: Prednisone Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To study and compare molecular response rates with the FND regimen followed by rituximab (chimeric anti-CD20 antibody) and interferon versus FND plus rituximab concurrently, followed by interferon [ Time Frame: 10 Years ]
  • To study the toxicity of these two regimens, including their effects on B- and T- cell subsets, immunoglobulins, and patterns of infections. [ Time Frame: 10 Years ]

Secondary Outcome Measures:
  • Compare failure-free and overall survival rates [ Time Frame: 10 Years ]
  • To identify and treat with a separate strategy those follicular lymphoma patients without bcl-2 mbr or mcr gene rearrangement ("germline" patients) [ Time Frame: 10 Years ]

Enrollment: 210
Actual Study Start Date: March 16, 1998
Study Completion Date: August 24, 2017
Primary Completion Date: August 24, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1: FND + Rituximab Followed by Interferon
Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon
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.
Other Name: 2-fluoro-Ara Amp
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.
Other Name: Mitoxantrone
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.
Other Name: Dexamethasone
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.
Other Names:
  • Chimeric Anti-CD20 Antibody
  • Anti-CD20
  • IDEC-C2B8
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.
Other Names:
  • Interferon Alpha-2b
  • IFN
Active Comparator: 2: FND Followed by Interferon & Rituximab
Fludarabine/Novantrone/Decadron Followed by Interferon & Rituximab
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.
Other Name: 2-fluoro-Ara Amp
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.
Other Name: Mitoxantrone
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.
Other Name: Dexamethasone
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.
Other Names:
  • Chimeric Anti-CD20 Antibody
  • Anti-CD20
  • IDEC-C2B8
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.
Other Names:
  • Interferon Alpha-2b
  • IFN
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
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.
Other Name: Mitoxantrone
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.
Other Name: Dexamethasone
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.
Other Names:
  • Chimeric Anti-CD20 Antibody
  • Anti-CD20
  • IDEC-C2B8
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.
Other Names:
  • Interferon Alpha-2b
  • IFN
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 76 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously untreated stage IV indolent B-cell lymphoma [Amendment May 2001: eligibility restricted to follicular lymphoma]
  2. Age <76

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577993


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech, Inc.
Investigators
Principal Investigator: Nathan Fowler, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00577993     History of Changes
Other Study ID Numbers: DM97-261
NCI-2010-01566 ( Registry Identifier: NCI CTRP )
First Submitted: December 18, 2007
First Posted: December 20, 2007
Last Update Posted: August 28, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
Follicular Lymphoma
Indolent Lymphoma
Fludarabine
Novantrone
Mitoxantrone
Decadron
Dexamethasone
Rituximab
Anti-CD20
IDEC-C2B8
Chimeric Anti-CD20 Antibody
Interferon
Interferon Alpha-2b
IFN
Doxorubicin
Vincristine
Bleomycin
Cyclophosphamide
Etoposide
Cisplatin
Ara-C
Methyl-Prednisolone
Procarbazine
Prednisone
FND

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Fludarabine
Fludarabine phosphate
Etoposide phosphate
Cisplatin
Dexamethasone
Cyclophosphamide
Rituximab
Doxorubicin
Interferons
Prednisone
Etoposide
Vincristine
Prednisolone
Methylprednisolone Hemisuccinate
Cytarabine
Mitoxantrone
Bleomycin
Procarbazine
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone