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A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8+ T Cell Clones For Patients With Relapsed Cd20+ Indolent Lymphomas

Phase 1
Not Enrolling
Leukemia, Lymphoma

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Trial Information

A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8+ T Cell Clones For Patients With Relapsed Cd20+ Indolent Lymphomas



- Determine the safety and toxicity of cellular immunotherapy with autologous CD8+
cytotoxic T-lymphocyte clones after chemotherapy comprising cyclophosphamide,
vincristine, and prednisone in patients with relapsed or refractory CD20+ indolent
lymphomas or mantle cell lymphoma.


- Determine the duration of in vivo persistence of adoptively transferred CD20-specific
CD8+ cytotoxic T-lymphocyte clones in the absence and presence of subcutaneous
interleukin-2 in these patients.

- Assess the trafficking of CD8+ cytotoxic T-lymphocyte clones to lymph nodes in these
patients treated with this regimen.

- Determine immune response and tumor response in patients treated with this regimen.

OUTLINE: This is an open-label, pilot study.

- Leukapheresis: Patients undergo leukapheresis. Selected CD20-specific CD8+ cells are
cultured to expand the cytotoxic T lymphocytes (CTL), which are then cloned.

- Chemotherapy:

Patients receive oral cyclophosphamide and oral prednisone on days 1-5 and vincristine IV on
day 1. Courses repeat every 3-4 weeks for a total of 6 courses.

- Immune cell infusion:

Beginning 4 weeks after the last course of chemotherapy (and lymph nodes ≤ 5 cm diameter or
≤ 5,000 circulating CD20+ lymphocytes/mm^3), patients receive autologous CD8+ CTL clones IV
over 30 minutes. Courses repeat every 2-5 days for a total of 3 courses in the absence of
disease progression or unacceptable toxicity. The last 6 patients receive interleukin-2
subcutaneously every 12 hours for 14 days, beginning 2 hours after the last infusion of CD8+
CTL clones.

After course 2 or 3 of immune cells, all patients undergo surgical lymph node biopsy to
determine if immune cells are moving to the lymph nodes.

Patients are followed monthly for 1 year and then annually for 2 years.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 4 years.

Inclusion Criteria


- Immunohistopathologically documented relapsed or refractory CD20+ indolent lymphomas
or mantle cell lymphoma

- Indolent B-cell lymphomas including any of the following subtypes:

- Follicular lymphoma (grade I, II, or III)

- Small lymphocytic lymphoma or chronic lymphocytic leukemia

- Marginal zone lymphoma (splenic, nodal, and extra-nodal)

- Lymphoplasmacytoid lymphoma

- Ineligible for or unwilling to participate in other FHCRC/UWMC protocols

- Serological evidence of prior exposure to Epstein-Barr virus

- Must agree to undergo peripheral blood drawing, bone marrow biopsy, lymph node
biopsy, and nuclear medicine imaging

- Must agree to cytoreductive chemotherapy if necessary to reduce lymph nodes to < 5 cm
in diameter or circulating B lymphocyte counts to < 5,000/mm^3

- No pulmonary involvement

- No CNS involvement



- Any age

Performance status:

- Not specified

Life expectancy:

- At least 90 days


- Not specified


- No active hepatitis B infection


- Not specified


- No HIV positivity

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of hypersensitivity reactions to murine proteins


Biologic therapy:

- At least 4 months since prior rituximab, tositumomab, or ibritumomab

- No prior allogeneic stem cell transplantation

- No other concurrent immunotherapy (e.g., interferons, vaccines, or other cellular


- At least 2 years since prior fludarabine or cladribine

- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- No concurrent systemic corticosteroids except to treat toxicity from chemotherapy or
cellular immunotherapy


- Not specified


- Not specified


- At least 4 weeks since prior immunosuppressive therapy and recovered

- No concurrent pentoxifylline

- No other concurrent investigational agents

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and toxicity by NCI CTC toxicity scale in patients w/ recurr. or refract. CD20+ follicular lymphoma who are not candidates for high dose chemoradiotx and stem cell transplant during each infusion, weekly for 4 wks and then monthly for a yr

Safety Issue:


Principal Investigator

Oliver W. Press, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

July 2010

Related Keywords:

  • Leukemia
  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • refractory chronic lymphocytic leukemia
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
City of Hope Comprehensive Cancer Center Duarte, California  91010
University of Washington School of Medicine Seattle, Washington  98195