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A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Mantle Cell Lymphoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Mantle Cell Lymphoma



- Determine the specific anti-tumor immune response in patients with relapsed or de novo
stage II, III, or IV mantle cell lymphoma treated with vaccine therapy comprising
autologous tumor cells and a sargramostim (GM-CSF)-producing and CD40L-expressing cell
line (GM.CD40L) combined with low-dose interleukin-2 after conventional chemotherapy.

- Determine the toxicity of this regimen in these patients.


- Determine the tumor response rate, time to progression, disease-free survival, and
overall survival of patients treated with this regimen.

OUTLINE: Patients undergo surgical resection of a malignant lymph node to collect autologous
tumor cells for vaccine production. Vaccine is formulated by combining equal volumes of
irradiated autologous tumor cells and irradiated cells from a cell line that produces
sargramostim (GM-CSF) and expresses CD40L (GM.CD40L).

- Conventional chemotherapy: Patients receive conventional chemotherapy comprising 6
courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3
courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and
dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for
patients who have relapsed after CHOP. Patients who achieve a partial or complete
response after completion of chemotherapy proceed to vaccine therapy.

- Vaccine therapy: Patients receive vaccine comprising autologous tumor cells and
GM.CD40L intradermally on day 1 and low-dose interleukin-2 (IL-2) subcutaneously twice
daily on days 1-14. Treatment repeats every 28 days for 4 courses. Patients who have
stable or responding disease at 12 months receive 4 additional courses of booster
vaccine and low-dose IL-2 as above. Treatment continues in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then annually thereafter.

PROJECTED ACCRUAL: A total of 40-60 patients will be accrued for this study within 15

Inclusion Criteria


- Histologically confirmed mantle cell lymphoma

- Stage II, III, or IV disease

- Relapsed or de novo disease

- No symptomatic brain metastasis



- 18 and over

Performance status

- Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

- Not specified


- White blood count (WBC) > 3,000/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hematocrit > 25%

- Hemoglobin > 8 g/dL


- Bilirubin < 2.0 mg/dL


- Creatinine < 2.0 mg/dL OR

- Creatinine clearance > 60 mL/min


- No serious ongoing infection

- No known HIV infection

- No other pre-existing immunodeficiency condition


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for 1 month before, during, and for
3 months after study treatment


Biologic therapy

- No other concurrent immunotherapy


- More than 4 weeks since prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- More than 4 weeks since prior steroids

- No concurrent corticosteroids except as replacement doses in patients who are


- More than 2 weeks since prior radiotherapy

- No concurrent radiotherapy


- Not specified


- No other concurrent immunosuppressive therapy

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Anti-Tumor Response

Outcome Description:

To evaluate patients for the development of specific anti-tumor immune responses after immunization with the autologous tumor cell / GM.CD40L bystander cell vaccine. Immunogenicity will be measured by in vitro testing of peripheral blood lymphocytes (PBLs) for cytokine-secreting T cells in enzyme-linked immunospot (ELISPOT) assays, delayed-type hypersensitivity (DTH) skin testing with irradiated autologous tumor cells, and biopsy of the DTH site for immunohistochemical analysis of infiltrating lymphocytes 48 hours after intradermal injection of autologous tumor cells. Vaccine injection sites will be biopsied to evaluate local response to vaccination.

Outcome Time Frame:

6 years

Safety Issue:


Principal Investigator

Sophie Dessureault, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

August 2013

Related Keywords:

  • Lymphoma
  • recurrent mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612