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A Phase II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Lymphoma

Phase 2
19 Years
Not Enrolling

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Trial Information

A Phase II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Lymphoma

OBJECTIVES: I. Determine the complete and partial response rate of patients with relapsed or
refractory B-cell non-Hodgkin's lymphoma treated with rituximab and high-dose carmustine,
etoposide, cytarabine and melphalan followed by autologous bone marrow or peripheral blood
stem cell transplantation. II. Determine the toxicity profile of this regimen in these
patients. III. Compare the levels of soluble CD20 antigen and rituximab blood levels with
patient outcomes in this patient population.

OUTLINE: Patients receive two doses of rituximab IV over 3-4 hours 1 week apart. Stem cells
from the peripheral blood or bone marrow are collected at least 1 week after the second dose
of rituximab. Following stem cell collection, patients receive a third dose of rituximab IV
as above between days -10 and -6. Patients then receive high-dose chemotherapy consisting of
carmustine IV on day -6, etoposide IV twice daily and cytarabine IV on days -5 to -2, and
melphalan IV on day -1. On day 0 patients undergo autologous bone marrow or peripheral blood
stem cell transplantation. After transplantation, patients receive a fourth dose of
rituximab as above at approximately day 30, and then weekly over 4 weeks at approximately 6
months in the absence of disease progression or unacceptable toxicity. Patients are followed
at 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 23-40 patients will be accrued for this study within 3 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma
Transplantation candidate Primary induction failure Chemotherapy refractory disease
Received at least 3 prior chemotherapy regimens OR Diagnosis of mantle cell lymphoma No
history of T-cell lymphoma No relapse or progression after rituximab therapy within 3
months before transplantation

PATIENT CHARACTERISTICS: Age: 19 and over Performance status: WHO 0-2 Life expectancy: At
least 6 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3* Platelet count
more than 50,000/mm3* Hemoglobin more than 9.0 g/dL* *Unless due to lymphomatous
involvement of the marrow Hepatic: Not specified Renal: Not specified Other: No serious
disease or condition that would preclude study Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent
corticosteroids except for transient control or prevention of nausea or vomiting
Concurrent non-steroidal hormones for non-lymphoma-related conditions (e.g., insulin for
diabetes) allowed Radiotherapy: No concurrent external beam radiotherapy during
transplantation therapy Surgery: Not specified Other: No other concurrent antitumoral or
investigational agents

Type of Study:


Study Design:

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

Outcome Measure:

The primary endpoint for this study is 100 day (complete + partial) response rate

Outcome Time Frame:

100 days

Safety Issue:


Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

January 2011

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of Nebraska Medical Center Omaha, Nebraska  68198-3330