Clinical trial NCT00225212: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Event-free Survival (EFS)
timeFrame: 24 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Sandra J Horning, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.