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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225212
• Other study ID #: protocol97
• Secondary ID: 73750
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2005
• Last updated: September 4, 2014
• Start date: November 1997
• Est. completion date: March 2003

Study information

• Verified date: September 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Mantle Cell Lymphoma
• Non-Hodgkin's Lymphoma
• Other Subtypes of B-cell Lymphoma
• Transformed Lymphoma

Intervention

Drug:
• Rituximab 375 mg/m2

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Horwitz SM, Negrin RS, Blume KG, Breslin S, Stuart MJ, Stockerl-Goldstein KE, Johnston LJ, Wong RM, Shizuru JA, Horning SJ. Rituximab as adjuvant to high-dose therapy and autologous hematopoietic cell transplantation for aggressive non-Hodgkin lymphoma. B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free Survival (EFS)	"Events" for EFS were defined as the earlier of post-ASCT relapse or death.	24 months	Yes
Secondary	Overall Survival (OS)		24 months	Yes