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

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.
ClinicalTrials.gov Identifier: NCT00577629
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : April 15, 2013
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Duke University

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).

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Drug: cyclophosphamide Drug: etoposide Drug: rituximab Drug: cytarabine Drug: doxorubicin Drug: tositumomab Phase 2

Detailed Description:
This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma
Actual Study Start Date : June 18, 2005
Primary Completion Date : April 8, 2012
Study Completion Date : November 3, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Induction + Consolidation + Bexxar
Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)
Drug: cyclophosphamide
1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2
Other Name: Cytoxan®
Drug: etoposide
300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.
Other Name: VP-16
Drug: rituximab
375mg/m2 each week x 4 weeks of induction, beginning on day 1
Other Name: Rituxan
Drug: cytarabine
3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
Other Name: Ara-C
Drug: doxorubicin
45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
Other Name: Adriamycin
Drug: tositumomab
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.
Other Name: Bexxar

Primary Outcome Measures :
  1. 1 Year Progression-free Survival Rate [ Time Frame: 1 year ]
    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.

Secondary Outcome Measures :
  1. Disease-free Survival [ Time Frame: 10 years ]
    Disease-free survival is measured from the date of CR or CRu to date of relapse or death

  2. Overall Survival [ Time Frame: 10 years ]
    Overall Survival is measured from the first day of chemotherapy until death from any cause.

  3. Overall Response [ Time Frame: up to 1 year ]

    Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.

    CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.

    PR =

    1. >/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
    2. No increase should be observed in the size of other nodes, liver, or spleen.
    3. Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.
    4. Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
    5. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.
    6. No new sites of disease should be observed.

  4. Secondary Malignancies [ Time Frame: 10 years ]
    The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT00577629

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: David Rizzieri, MD Duke Unversity Medical Center

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00577629     History of Changes
Other Study ID Numbers: Pro00007096
GSK-103421 ( Other Grant/Funding Number: GSK )
5762 ( Other Identifier: DUMC old IRB # )
First Posted: December 20, 2007    Key Record Dates
Results First Posted: April 15, 2013
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Duke University:
high risk non-hodgkins lymphoma
high dose chemotherapy

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Etoposide phosphate
Iodine-131 anti-B1 antibody
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors