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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00577629
First received: December 18, 2007
Last updated: May 20, 2014
Last verified: March 2014

December 18, 2007
May 20, 2014
June 2005
February 2012   (final data collection date for primary outcome measure)
1 Year Progression-free Survival Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00577629 on ClinicalTrials.gov Archive Site
  • Disease-free Survival in Patients With a Complete Response (CR or CRu) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Disease-free survival is measured from the date of CR or CRu to date of relapse or death
  • Overall Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Overall Survival is measured from the first day of chemotherapy until death from any cause.
  • Overall Response [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

    Number 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 ] [ Designated as safety issue: Yes ]
    The number of patients who develop a secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.
toxicity [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]
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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
Interventions:
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
39
February 2021
February 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577629
Pro00007096, GSK-103421, 5762
No
Duke University
Duke University
GlaxoSmithKline
Principal Investigator: David Rizzieri, MD Duke Unversity Medical Center
Duke University
March 2014

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