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


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin's

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess safety and toxicity after rituximab and high-dose chemotherapy

Principal Investigator

Raymond J. Hutchinson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

UMCC 0074

NCT ID:

NCT00143871

Start Date:

April 2001

Completion Date:

January 2007

Related Keywords:

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

Name

Location
The University of Michigan Ann Arbor, Michigan  48109