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

Primary Purpose

Non-Hodgkin's Lymphoma, Diffuse Large Cell Lymphoma, Mantle Cell Lymphoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rituximab 375 mg/m2

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring non-Hodgkin's lymphoma, diffuse large cell lymphoma, mantle cell lymphoma, transformed lymphoma, other subtypes of B cell lymphoma, recurrent lymphoma

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab after ASCT

Arm Description

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.

Outcomes

Primary Outcome Measures

Event-free Survival (EFS)

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

Secondary Outcome Measures

Overall Survival (OS)

Full Information

NCT ID

NCT00225212

First Posted

September 21, 2005

Last Updated

September 4, 2014

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT00225212

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

November 1997 (undefined)

Primary Completion Date

March 2003 (Actual)

Study Completion Date

March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

non-Hodgkin's lymphoma, diffuse large cell lymphoma, mantle cell lymphoma, transformed lymphoma, other subtypes of B cell lymphoma, recurrent lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rituximab after ASCT

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Rituximab 375 mg/m2

Other Intervention Name(s)

Rituxan, MabThera, Zytux, IDEC-C2B8, chimeric anti-CD20

Primary Outcome Measure Information:

Title

Event-free Survival (EFS)

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra J Horning, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University Medical Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12907446

Citation

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. Blood. 2004 Feb 1;103(3):777-83. doi: 10.1182/blood-2003-04-1257. Epub 2003 Aug 7.

Results Reference

result

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

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