Skip to main content
OpenTrials
Completed

NCT Number: NCT00225212

Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Hodgkin's Lymphoma Diffuse Large Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Neoplasms Neoplasms by Histologic Type Other Subtypes of B-cell Lymphoma Transformed Lymphoma

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University Medical Center

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab 375 mg/m2

Drug

Other names: Rituxan, MabThera, Zytux, IDEC-C2B8, chimeric anti-CD20

Primary outcomes

  1. Event-free Survival (EFS)

    Time frame: 24 months

    "Events" for EFS were defined as the earlier of post-ASCT relapse or death.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma

Important dates

Study start
1997
Primary completion
2003
Study completion
2003
First posted
Sep 23, 2005
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.