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Randomized, Double-Blind Study Of Peripheral Blood Progenitor Cell (PBPC) Mobilization By Pegfilgrastim Or Filgrastim For Autologous Transplantation In Subjects With Hodgkin's Or Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Randomized, Double-Blind Study Of Peripheral Blood Progenitor Cell (PBPC) Mobilization By Pegfilgrastim Or Filgrastim For Autologous Transplantation In Subjects With Hodgkin's Or Non-Hodgkin's Lymphoma


OBJECTIVES:

- Compare the CD34+ cells/kg yield from patients receiving single-dose pegfilgrastim (2
different doses) or daily filgrastim (G-CSF) for peripheral blood progenitor cell
(PBPC) mobilization and collection for autologous transplantation in patients with
Hodgkin's or non-Hodgkin's lymphoma.

- Compare the safety of these regimens in these patients.

- Determine the CD34+ cell dynamics and pharmacokinetics of pegfilgrastim in peripheral
blood during the collection phase in these patients.

- Evaluate engraftment of PBPC mobilized by pegfilgrastim in these patients.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to amount of prior chemotherapy or radiotherapy (heavily pretreated vs non-heavily
pretreated). Patients are randomized to 1 of 3 treatment arms.

- Peripheral blood progenitor cell (PBPC) mobilization:

- Arm I: Patients receive lower dose pegfilgrastim subcutaneously (SC) on day 1 and
placebo SC on days 1-9.

- Arm II: Patients receive higher dose pegfilgrastim SC on day 1 and placebo SC on
days 2-9.

- Arm III: Patients receive filgrastim (G-CSF) SC on days 1-9.

- Leukapheresis: Patients undergo leukapheresis daily, beginning on day 5 until the
desired yield of CD34+ cells is obtained or a maximum of 5 leukaphereses is reached.

- Conditioning: Patients receive a myeloablative chemotherapy regimen as per
institutional practice.

- Transplantation of PBPC: Approximately 1-3 days after completion of the conditioning
regimen, patients undergo reinfusion of autologous PBPC. Patients receive G-CSF SC
beginning on day of reinfusion and continuing until blood counts recover.

Patients are followed at 60 and 100 days.

PROJECTED ACCRUAL: A total of 90 patients (30 patients per treatment arm) will be accrued
for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed Hodgkin's or non-Hodgkin's lymphoma of any cellular type

- Suitable for peripheral blood progenitor cell (PBPC) mobilization and transplantation

- No CNS primary or metastatic malignancy

- No evidence of myelodysplastic syndromes or sickle cell disease

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 80,000/mm^3

- No hemolytic anemia or hemoglobinopathy

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- No hepatic cirrhosis

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- More than 6 months since prior coronary angioplasty

- No uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mm Hg)

- No unstable angina

- No New York Heart Association class III or IV congestive heart failure

- No uncontrolled atrial or ventricular cardiac arrhythmias

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No other prior malignancy except curatively treated basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix or a surgically cured malignancy

- No significant nonmalignant disease

- No acute or chronic infections (e.g., malaria)

- No inflammatory disease (e.g., Felty's syndrome, systemic lupus erythematosus, or
sarcoidosis)

- No storage diseases (e.g., Gaucher's disease)

- No other concurrent diagnosis that could cause splenomegaly or hypersplenism

- No poorly controlled diabetes

- No known sensitivity to any study products

- No known hypersensitivity to E. coli-derived pharmaceutical products (e.g., G-CSF,
pegfilgrastim, Humulin® insulin, or asparaginase)

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior bone marrow or PBPC transplantation

- More than 1 week since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

- WBC must be less than 15,000/mm^3 if growth factor support was administered
concurrently with prior chemotherapy

- No other concurrent G-CSF or GM-CSF

- No other concurrent myeloid stimulating factors

- No concurrent radioimmunotherapy

Chemotherapy

- More than 3 weeks since prior myelosuppressive chemotherapy

Endocrine therapy

- More than 14 days since prior corticosteroids

- No concurrent corticosteroids

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 7 days since prior lithium

- More than 30 days since prior investigational device or drug study

- No concurrent participation in another investigational device or drug study

- No concurrent lithium

- No other concurrent investigational agent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000301567

NCT ID:

NCT00060229

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV mantle cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent mantle cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III 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
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781