NCT00225212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
9 years until next milestone

Results Posted

Study results publicly available

September 5, 2014

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

5.3 years

First QC Date

September 21, 2005

Results QC Date

August 26, 2014

Last Update Submit

September 4, 2014

Conditions

Non-Hodgkin's LymphomaDiffuse Large Cell LymphomaMantle Cell LymphomaTransformed LymphomaOther Subtypes of B-cell LymphomaLymphoma

Keywords

non-Hodgkin's lymphomadiffuse large cell lymphomamantle cell lymphomatransformed lymphomaother subtypes of B cell lymphomarecurrent lymphoma

Outcome Measures

Primary Outcomes (1)

  • Event-free Survival (EFS)

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

    24 months

Secondary Outcomes (1)

  • Overall Survival (OS)

    24 months

Study Arms (1)

Rituximab after ASCT

EXPERIMENTAL

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

Interventions

Rituximab 375 mg/m2DRUG
Also known as: Rituxan, MabThera, Zytux, IDEC-C2B8, chimeric anti-CD20
Rituximab after ASCT

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

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

    PMID: 12907446RESULT

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Neal Birkett, MS, RAC
Organization
Stanford University Medical Center
nbirkett@stanford.edu
650-723-6456

Study Officials

  • Sandra J Horning, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

November 1, 1997

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

September 15, 2014

Results First Posted

September 5, 2014

Record last verified: 2014-09

Locations

US(1)