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

Lymphoma, Non-Hodgkin's Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00141700
• Other study ID #: UMCC 2-51
• Status: Terminated
• Phase: Phase 2
• First received: August 30, 2005
• Last updated: December 28, 2007
• Start date: March 2003
• Est. completion date: December 2005

Study information

• Verified date: December 2007
• 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, stem cell support and Rituximab (which is a form of immunotherapy).

Description:

Combination chemotherapy is the standard treatment as initial therapy for aggressive NHL. Standard chemotherapy cures less than 40% of patients. High-dose chemotherapy with stem cell support (or transplant) is showing some positive results in patients with NHL that fail standard chemotherapy. The cure rate of this treatment is only about 50%.

Another treatment option called immunotherapy is being tested in lymphoma patients to see if adding immunotherapy to NHL treatments improves results. Rituximab, a form of immunotherapy, is an antibody (a type of protein) that attacks the CD20 protein found on lymphoma cell, which may result in the death of the lymphoma cell.

The study design is as follows: Patients with poor prognosis NHL receive rituximab as part of the peripheral blood progenitor cell mobilization process and as part of the preparative regimen in combination with high-dose chemotherapy. Granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood progenitor cells (PBPC) are collected and stored. After recovery from high-dose cyclophosphamide, patients are admitted to the hospital for transplant. The preparative regimen consists of rituximab, followed by high-dose chemotherapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2005
• Est. primary completion date: March 2005
• 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.

• Histologic subtypes include follicular large cell, diffuse small cleaved cell, diffuse mixed small and large cell, diffuse large cell, anaplastic large cell, and mantle cell lymphomas.

• NHL must have high-intermediate or high International Prognostic Index (standard IPI) score at diagnosis. Mantle cell NHL is eligible regardless of IPI score.

• Complete or partial response to first-line therapy.

• Treated CNS or meningeal disease, using radiation therapy and/or intrathecal chemotherapy, is allowed. Patients with meningeal disease must have cytologically negative CSF at time of study entry.

• Cumulative total doxorubicin: <500 mg/m2

• Performance score 0-2

• Patients with a prior malignancy are eligible if they were treated with curative intent and have no evidence of active disease.

• Patients must not be pregnant or nursing.

• Informed Consent

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 progression-free survival after rituximab and high-dose chemotherapy with autologous PBPC support;
Secondary	Assess overall survival (OS) after rituximab and high-dose chemotherapy with PBPC support.
Secondary	Assess safety and toxicity after rituximab and high-dose chemotherapy.
Secondary	Assess CD20 recovery post-transplant