- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005787
Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma
Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant.
PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with high-dose chemotherapy.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- neutropenia
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular 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
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Agranulocytosis
- Leukopenia
- Leukocyte Disorders
- Lymphoma
- Neutropenia
- Physiological Effects of Drugs
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Hematinics
- Radiation-Protective Agents
- Epoetin Alfa
- Sargramostim
- Flt3 ligand protein
Other Study ID Numbers
- NU 99Z1
- NU-99Z1
- NCI-G00-1734
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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