Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0212095 AMGEN-20020134, NCT00066833

Objectives

1. Compare the safety and efficacy, as measured by the duration of grade 4 neutropenia, of two different schedules of pegfilgrastim administered 4 hours vs 24 hours after cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP) in patients with stage III or IV or bulky stage II mantle cell or diffuse large B-cell non-Hodgkin's lymphoma .
2. Compare response rates in patients treated with these regimens.
3. Compare the number of patients who receive all planned doses of this chemotherapy regimen on time when treated with two different schedules of pegfilgrastim.
4. Compare the hematologic and nonhematologic toxic effects of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histological confirmation of 1 of the following non-Hodgkin's lymphomas:
  • Mantle cell lymphoma
    • CD5 positive and CD23 negative
  • Diffuse large B-cell lymphoma, according to the REAL classification
    • International Prognostic Index score 0-2
    • Measurable or evaluable disease



• Ann Arbor stage III or IV or bulky stage II disease



• No Burkitt's or B-lymphoblastic lymphoma



• No premalignant myeloid conditions or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes or acute or chronic myelogenous leukemia)



• No T-cell lymphoma or history of indolent lymphoma



• No CNS involvement

Prior/Concurrent Therapy:

Biologic therapy

• No prior bone marrow or stem cell transplantation
• No prior pegfilgrastim
• No other concurrent hematopoietic growth factors, except epoetin alfa for anemia
• No concurrent WBC transfusions

Chemotherapy

• Not specified

Endocrine therapy

• No other concurrent corticosteroids, except any of the following:
  • Protocol-specific prednisone
  • Topical or inhaled steroids
  • Premedication for chemotherapy
  • Treatment for an adverse event

Radiotherapy

• No concurrent radiotherapy

Surgery

• More than 2 weeks since prior major surgery

Other

• No prior therapy for malignancy
• At least 30 days since prior participation in an investigational device or drug study
• No concurrent enrollment in another investigational device or drug study
• No other concurrent investigational agents

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count greater than 1,000/mm³
• Platelet count greater than 75,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic

• AST and ALT less than 3 times upper limit of normal (ULN)
• Bilirubin no greater than 1.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

  OR

• Creatinine clearance at least 50 mL/min

Cardiovascular

• No history of impaired cardiac status
• No severe heart disease
• No cardiomyopathy
• No congestive heart failure
• LVEF at least 50% at rest by MUGA or echocardiogram

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study participation
• HIV negative
• No active infection requiring treatment with systemic (IV or oral) anti-infectives (antibiotic, antifungal, or antiviral) within 72 hours of study therapy
• No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No neurological contraindication to vincristine (e.g., peripheral neuropathy)
• No known sensitivity to E. coli-derived drug products (e.g., filgrastim [G-CSF], Humulin® insulin, asparaginase, somatotropin, or interferon alfa)
• No psychiatric, addictive, or other disorder that would preclude study compliance or giving informed consent

Expected Enrollment

A total of 16-90 patients (8-45 per treatment arm) will be accrued for this study within 6-20 months.

Outcomes

Duration of grade 4 neutropenia in course 1

Duration of grade 4 neutropenia in course 4
Absolute neutrophil count nadir in courses 1 and 4
Incidence of grade 3 or 4 neutropenia in courses 1 and 4
Proportion of patients achieving partial or complete response at the end of course 6
Incidence of febrile neutropenia in all courses
Proportion of patients receiving all planned doses of chemotherapy on time over all courses

Outline

This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to lymphoma type (mantle cell vs diffuse large B-cell). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive R-CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 (within 4 hours after completion of R-CHOP) and placebo SC on day 2 (within 24 hours after completion of R-CHOP).



• Arm II: Patients receive R-CHOP as in arm I. Patients also receive placebo SC on day 1 (within 4 hours after completion of R-CHOP) and pegfilgrastim SC on day 2 (within 24 hours after completion of R-CHOP).

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Sven De Vos, MD, Principal investigator		Ph: 310-825-6877 Email: devos@mednet.ucla.edu

Registry Information
Official Title		A Multicenter, Double-Blind, Randomized, Phase II Study Of Pegfilgrastim Administered On The Same Day Or Next Day Of R-CHOP Chemotherapy In Subjects With Non-Hodgkin's Lymphoma
Trial Start Date		2003-07-08
Registered in ClinicalTrials.gov		NCT00066833
Date Submitted to PDQ		2003-07-07
Information Last Verified		2006-04-11
NCI Grant/Contract Number		CA16042

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