Know Cancer

forgot password

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

Phase 2
Not Enrolling
Lymphoma, Non-Hodgkin's

Thank you

Trial Information

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

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Assess progression-free survival after rituximab and high-dose chemotherapy with autologous PBPC support;

Principal Investigator

Raymond J. Hutchinson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2-51



Start Date:

March 2003

Completion Date:

December 2005

Related Keywords:

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



The University of Michigan Ann Arbor, Michigan  48109