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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00577993
First received: December 18, 2007
Last updated: September 5, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare failure-free and overall survival rates [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: March 1998
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   up to 76 Years
Genders Eligible for Study:   Both
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:

N/A

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577993

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00577993     History of Changes
Other Study ID Numbers: DM97-261
Study First Received: December 18, 2007
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

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
Interferon-alpha
Cytarabine
Interferons
Vidarabine
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Cyclophosphamide
Fludarabine phosphate
Rituximab
Bleomycin
Doxorubicin
Liposomal doxorubicin
Etoposide phosphate
Fludarabine
Cisplatin
Dexamethasone
Etoposide
Methylprednisolone Hemisuccinate
Prednisolone
Mitoxantrone
Prednisone
Procarbazine

ClinicalTrials.gov processed this record on August 01, 2014