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Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy


Phase 1
17 Years
65 Years
Not Enrolling
Both
Lymphoma, Neutropenia

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Trial Information

Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy


OBJECTIVES:

- Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells (EVE
PBMNC) as a supplement to high-dose chemotherapy and conventional autograft in patients
with relapsed or refractory non-Hodgkin's lymphoma.

- Compare the effect of EVE PBMNC on white blood cell, red blood cell, and platelet
recovery in patients on this study vs historical controls, matched by protocol, disease
status, and prior therapy.

- Determine the optimal duration of culture and time of harvest for the production of
neutrophils in vivo.

- Determine the relationships between length of culture, immunophenotype, and clinical
outcome.

- Determine the required numbers of white blood cell precursors for clinical efficacy.

- Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation
period.

OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected
PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF),
sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0.

Patients are followed monthly for 1 year.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven relapsed or refractory non-Hodgkin's lymphoma

- Scheduled to undergo high-dose chemotherapy (carmustine, etoposide, cytarabine, and
melphalan) with autologous peripheral blood mononuclear cell transplantation

- No metastatic disease involving the bone marrow

PATIENT CHARACTERISTICS:

Age:

- 17 to 65

Performance status:

- ECOG 0 or 1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- No active hepatitis B or C

- Bilirubin less than 2.5 times normal*

- SGOT or SGPT less than 2.5 times normal*

- Alkaline phosphatase less than 2.5 times normal NOTE: * Unless Gilbert's syndrome
present

Renal:

- Creatinine clearance greater than 50 mL/min

Cardiovascular:

- Cardiac ejection fraction normal

Pulmonary:

- DLCO at least 50% predicted

- FEV_1 and FVC at least 75% predicted

Other:

- HIV negative

- Not pregnant

- Negative pregnancy test

- No non-neoplastic disease that would preclude intensive chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior external beam radiotherapy to more than 25% of the active bone marrow

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Jane N. Winter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 99Z1

NCT ID:

NCT00005787

Start Date:

September 1999

Completion Date:

January 2002

Related Keywords:

  • Lymphoma
  • Neutropenia
  • neutropenia
  • 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 lymphoblastic 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
  • Neutropenia

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611