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

NCT00577993 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: DM97-261NCI-2010-01566
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Survival (10 Years) by Treatment

  Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years.

  10 Years

Secondary Outcomes (1)

• Number of Participants With Progression Free Survival (10 Years) by Treatment

  10 years

Study Arms (3)

1: FND + Rituximab Followed by Interferon

ACTIVE COMPARATOR

Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon

Drug: Fludarabine; Drug: Novantrone; Drug: Decadron; Drug: Rituximab; Drug: Interferon

2: FND Followed by Interferon & Rituximab

ACTIVE COMPARATOR

Fludarabine/Novantrone/Decadron Followed by Interferon \& Rituximab

Drug: Fludarabine; Drug: Novantrone; Drug: Decadron; Drug: Rituximab; Drug: Interferon

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

ACTIVE COMPARATOR

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; 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

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.

Also known as: 2-fluoro-Ara Amp

1: FND + Rituximab Followed by Interferon; 2: FND Followed by Interferon & Rituximab

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.

Also known as: Mitoxantrone

1: FND + Rituximab Followed by Interferon; 2: FND Followed by Interferon & Rituximab; 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

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.

Also known as: Dexamethasone

1: FND + Rituximab Followed by Interferon; 2: FND Followed by Interferon & Rituximab; 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

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.

Also known as: Chimeric Anti-CD20 Antibody, Anti-CD20, IDEC-C2B8

1: FND + Rituximab Followed by Interferon; 2: FND Followed by Interferon & Rituximab; 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

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.

Also known as: Interferon Alpha-2b, IFN

1: FND + Rituximab Followed by Interferon; 2: FND Followed by Interferon & Rituximab; 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Doxorubicin DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Vincristine DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Bleomycin DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Cyclophosphamide DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Etoposide DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Cisplatin DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Ara-C DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Methyl-Prednisolone DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Procarbazine DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Prednisone DRUG

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

3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon

Eligibility Criteria

• Age: Up to 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

fludarabine; Mitoxantrone; Calcium Dobesilate; Dexamethasone; Rituximab; Interferons; Introns; Doxorubicin; Vincristine; Bleomycin; Cyclophosphamide; Etoposide; Cisplatin; Cytarabine; Procarbazine; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Glycopeptides; Glycoconjugates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Pregnadienediols

Results Point of Contact

• Title: Nathan Fowler,MD, Clinical Professor, Lymphoma-Myeloma
• Organization: UT MD Anderson Cancer Center

nfowler@mdanderson.org

(832) 671-3018

Study Officials

• Nathan Fowler, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: March 16, 1998
• Primary Completion: August 24, 2017
• Study Completion: August 24, 2017
• Last Updated: November 16, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-10

Locations

US (1)