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Phase II Trial of Rituximab and Autologous Stem Cell Transplantation for Refractory B Cell Large Cell Lymphoma

Phase 2
18 Years
70 Years
Not Enrolling

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Trial Information

Phase II Trial of Rituximab and Autologous Stem Cell Transplantation for Refractory B Cell Large Cell Lymphoma


- Determine the disease-free and overall survival of patients with refractory diffuse
large B-cell lymphoma treated with stem cell mobilization comprising rituximab,
cyclophosphamide, and filgrastim (G-CSF) followed by high-dose chemotherapy comprising
carmustine, etoposide, and cyclophosphamide and autologous peripheral blood stem cell
transplantation, rituximab, and sargramostim (GM-CSF).

- Determine any potential infectious complications in patients treated with this regimen.

- Determine the effect of GM-CSF on antibody-dependent cellular cytotoxicity in patients
treated with this regimen.

OUTLINE: Stem cell mobilization: Patients receive rituximab IV over 4-8 hours on days 1, 5,
8, and 13. Patients also receive cyclophosphamide IV over 1-2 hours on day 9 and filgrastim
(G-CSF) subcutaneously (SC) once daily beginning on day 10 and continuing until an adequate
number of peripheral blood stem cells (PBSC) are collected.

High-dose preparative regimen: Patients receive carmustine IV over 2 hours on day -6,
etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2.

Autologous PBSC transplantation: Patients undergo autologous PBSC transplantation on day 0.
Patients receive sargramostim (GM-CSF) SC once daily beginning on day 6 and continuing until
blood counts recover.

Post-transplant regimen: Patients receive GM-CSF SC once daily on days 42-73, 177-208,
362-393, 543-574, and 727-758. Patients also receive rituximab IV over 4-8 hours on days 45,
52, 59, 66, 180,187, 194, 201, 365, 372, 379, 386, 546, 553, 560, 567, 730, 737, 744, and

After completion of study treatment, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of diffuse large B-cell lymphoma, meeting 1 of the following criteria:

- Failed to achieve at least partial remission

- Failed to respond to prior primary therapy or salvage chemotherapy

- Disease progression within 6 weeks after achieving remission

- CD20 expression at diagnosis or relapse

- No more than 4 prior regimens using chemotherapy, radiotherapy, or immunotherapy

- The addition of radiotherapy or a monoclonal antibody to chemotherapy is
considered 1 treatment regimen provided the addition was part of the initial
treatment plan

- The addition of these therapies due to lack of response or poor response is
considered an additional treatment regimen whether given in the front line
or salvage setting


Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3


- Direct bilirubin ≤ 2 mg/dL

- AST or ALT < 3 times upper limit of normal


- Creatinine ≤ 2.0 mg/dL


- Ejection fraction ≥ 40%


- DLCO ≥ 60% of predicted


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 2 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No active infection requiring oral or IV antibiotics

- HIV negative


Biologic therapy

- See Disease Characteristics

- See Radiotherapy


- See Disease Characteristics


- See Disease Characteristics

- No prior radioimmunotherapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year event free survival

Safety Issue:


Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:

CDR0000447158 J0376



Start Date:

March 2004

Completion Date:

January 2010

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410