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Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's 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: NCT00225212
Recruitment Status : Completed
First Posted : September 23, 2005
Results First Posted : September 5, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:

Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects.

This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.

Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.


Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Diffuse Large Cell Lymphoma Mantle Cell Lymphoma Transformed Lymphoma Other Subtypes of B-cell Lymphoma Lymphoma Drug: Rituximab 375 mg/m2 Phase 2

Detailed Description:

The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant.

After an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma
Study Start Date : November 1997
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003


Arm Intervention/treatment
Experimental: Rituximab after ASCT
Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT.
Drug: Rituximab 375 mg/m2
Other Names:
  • Rituxan
  • MabThera
  • Zytux
  • IDEC-C2B8
  • chimeric anti-CD20




Primary Outcome Measures :
  1. Event-free Survival (EFS) [ Time Frame: 24 months ]
    "Events" for EFS were defined as the earlier of post-ASCT relapse or death.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • B-cell, CD20+ NHL
  • Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Creatinine < 2 mg/dL
  • Bilirubin < 2.0 mg/dL
  • Liver function tests (LFTs) < 5 x upper limit of normal (ULN)

Exclusion Criteria:

  • Graft source from bone marrow
  • Non-responders [progressive disease (PD) or stable disease (SD)] to prior anti-CD20 therapy
  • PD after ASCT
  • Post-ASCT radiotherapy
  • Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab
  • Evidence of active pneumonitis
  • Evidence of active infection
  • Concurrent prednisone or other systemic steroid medication
  • Nitrosourea therapy within 6 weeks of the first treatment with rituximab
  • Presence of anti-murine antibody (HAMA) reactivity

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): NCT00225212


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Sandra J Horning, MD Stanford University

Publications of Results:
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00225212    
Other Study ID Numbers: protocol97
73750 ( Other Identifier: Stanford IRB, old system )
First Posted: September 23, 2005    Key Record Dates
Results First Posted: September 5, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by Stanford University:
non-Hodgkin's lymphoma
diffuse large cell lymphoma
mantle cell lymphoma
transformed lymphoma
other subtypes of B cell lymphoma
recurrent lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents