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. 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

December 18, 2007
December 20, 2007
March 4, 2013
April 15, 2013
May 30, 2017
June 18, 2005
April 8, 2012   (Final data collection date for primary outcome measure)
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.
progression free survival [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00577629 on Archive Site
  • 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
  • Overall Survival [ Time Frame: 10 years ]
    Overall Survival is measured from the first day of chemotherapy until death from any cause.
  • 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.
  • 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.
toxicity [ Time Frame: 30 days post-treatment ]
Not Provided
Not Provided
Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma
Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma
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).
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
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma, B-Cell
  • 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
Experimental: Induction + Consolidation + Bexxar
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 3, 2016
April 8, 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
GSK-103421 ( Other Grant/Funding Number: GSK )
5762 ( Other Identifier: DUMC old IRB # )
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
Plan to Share IPD: No
Duke University
Duke University
Principal Investigator: David Rizzieri, MD Duke Unversity Medical Center
Duke University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP