Study of Rituximab Plus High-Dose Chemotherapy Non-Hodgkin's Lymphoma

Lymphoma, Non-Hodgkin's Clinical Trial

Official title:

Rituximab Plus High-dose Chemotherapy With Autologous Stem Cell Support for Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143871
• Other study ID #: UMCC 0074
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2005
• Last updated: January 30, 2012
• Start date: April 2001
• Est. completion date: January 2007

Study information

• Verified date: January 2012
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, plus the addition of Rituximab (which is a form of immunotherapy).

Description:

Combination chemotherapy is the standard treatment as initial therapy for advanced stage aggressive Non-Hodgkin's lymphoma (NHL). Standard chemotherapy cures less than 40% of patients. When patients relapse, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. Multiple studies have shown the value of high-dose chemotherapy, with increased disease-free survival and overall survival, when compared with second-line conventional chemotherapy. Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it, and other treatment strategies are needed to improve the cure rate.

Another treatment option called immunotherapy is being tested in lymphoma patients. Immunotherapy involves attempts to use the immune system or products of the immune system to fight lymphoma. For example, NHL cells have a protein called CD20 on their surface. Rituximab is an antibody directed against the CD20 protein, which may result in the death of the lymphoma cell. Patients in this study will receive Rituximab to see if it is a safe treatment option for NHL patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Histologically documented, aggressive and/ or intermediate grade and high-grade B cell NHL, CD20 positive.

• In relapse after primary conventional chemotherapy

• Tumor sensitive (at least a partial response) to induction chemotherapy and/ or radiation therapy after treatment for relapse

• Treatment of CNS or meningeal disease (cytology-negative CSF) if present

• Treatment of CNS or meningeal disease (cytology-negative CSF) if present.

• Cumulative total doxorubicin dosage <500 mg/m2

• Performance score: 0-2

• Prior malignancies eligible if treated for cure and without active disease

• Patients must not be pregnant or nursing.

• Prior Immunotherapy is allowed

• Signed Informed Consent

• Absolute neutrophil count > 1500/ µl, platelet count >100,000/ µl

• Bilirubin <1.5 x normal, SGOT <2.5 x normal

• Serum creatinine <1.5 mg/dl

• Ejection fraction > 45% or > 40% with normal wall motion

• HIV negative

• FEV1, DLCO > 50% predicted

Exclusion Criteria:

• Pregnant or nursing

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Lymphoma, Non-Hodgkin's

Intervention

Drug:
• Rituximab

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess safety and toxicity after rituximab and high-dose chemotherapy
Secondary	Assess CD20 depletion in leukapheresis products after rituximab and high-dose chemotherapy, and monitor CD20 recovery post-transplant
Secondary	Assess the response rate after rituximab and high-dose chemotherapy with autologous peripheral blood progenitor cell (PBPC) support, for patients with relapsed CD20+ Non-Hodgkin's lymphoma (NHL)
Secondary	Assess progression-free and overall survival after rituximab and high-dose chemotherapy with PBPC support