Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

NCT00577629 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: Pro00007096GSK-1034215762
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

Conditions

Lymphoma, B-Cell

Keywords

high risk non-hodgkins lymphoma; NHL; Bexxar; high dose chemotherapy

Outcome Measures

Primary Outcomes (1)

• 1 Year Progression-free Survival Rate

  Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: \>50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.

  1 year

Secondary Outcomes (4)

• Disease-free Survival

  10 years

• Overall Survival

  10 years

• Overall Response

  up to 1 year

• Secondary Malignancies

  10 years

Study Arms (1)

Induction + Consolidation + Bexxar

EXPERIMENTAL

Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)

Drug: cyclophosphamide; Drug: etoposide; Drug: rituximab; Drug: cytarabine; Drug: doxorubicin; Drug: tositumomab

Interventions

cyclophosphamide DRUG

1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2

Also known as: Cytoxan®

Induction + Consolidation + Bexxar

etoposide DRUG

300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.

Also known as: VP-16

Induction + Consolidation + Bexxar

rituximab DRUG

375mg/m2 each week x 4 weeks of induction, beginning on day 1

Also known as: Rituxan

Induction + Consolidation + Bexxar

cytarabine DRUG

3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses

Also known as: Ara-C

Induction + Consolidation + Bexxar

doxorubicin DRUG

45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation

Also known as: Adriamycin

Induction + Consolidation + Bexxar

tositumomab DRUG

450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Also known as: Bexxar

Induction + Consolidation + Bexxar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated, biopsy proven B-cell non-Hodgkin's lymphoma
• Age \>/= 18 years
• No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year. The patient cannot have been exposed to chemotherapy to treat any of these diseases for at least 3 years prior to study entry.
• Meet staging studies and laboratory tests prior to induction, consolidation and radioimmunotherapy.

You may not qualify if:

• Significant medical and/or psychiatric illness which may compromise planned treatment;
• Pregnant or lactating;
• HIV-infection.
• Patients with follicular lymphoma grade 1, 2 or 3A are not eligible for this trial.

Sponsors & Collaborators

• Duke University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Cyclophosphamide; Etoposide; Rituximab; Cytarabine; Doxorubicin; tositumomab I-131

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides

Results Point of Contact

• Title: Anne Beaven, MD
• Organization: Duke University Medical Center

anne.beaven@duke.edu

919-684-8964

Study Officials

• David Rizzieri, MD

  Duke Unversity Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: June 18, 2005
• Primary Completion: April 8, 2012
• Study Completion: November 3, 2016
• Last Updated: May 30, 2017
• Results First Posted: April 15, 2013

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)