Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

epoetin alfa

filgrastim

recombinant flt3 ligand

recombinant interleukin-3

sargramostim

in vitro-treated peripheral blood stem cell transplantation

About this trial

This is an interventional supportive care trial for Lymphoma focused on measuring 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

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00005787

First Posted

June 2, 2000

Last Updated

May 31, 2012

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00005787

Brief Title

Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Terminated

Why Stopped

Per PI due to poor/inadequate accrual.

Study Start Date

September 1999 (undefined)

Primary Completion Date

January 2002 (Actual)

Study Completion Date

January 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Neutropenia

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

epoetin alfa

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Biological

Intervention Name(s)

recombinant flt3 ligand

Intervention Type

Biological

Intervention Name(s)

recombinant interleukin-3

Intervention Type

Biological

Intervention Name(s)

sargramostim

Intervention Type

Procedure

Intervention Name(s)

in vitro-treated peripheral blood stem cell transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane N. Winter, MD

Organizational Affiliation

Robert H. Lurie Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611-3013

Country

United States

Lymphoma, Neutropenia

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial