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

Alternate Title

Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	Other	BNLI-GOODRISKHIV EU-20144, NCT00032149

Objectives

1. Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) HIV-related non-Hodgkin's lymphoma.
2. Determine the effects of this regimen on response rate, time to disease progression, and survival in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed previously untreated HIV-related non-Hodgkin's lymphoma with 1 of the following:
  • Prior diagnosis of acquired immune deficiency syndrome (AIDS)
  • CD4 count < 100,000/mm3
  • ECOG performance status > 2

Prior/Concurrent Therapy:

Biologic:

• Not specified

Chemotherapy:

• Not specified

Endocrine:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 and over

Performance status:

• See Disease Characteristics

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Not specified

Renal:

• Not specified

Expected Enrollment

A total of 15-30 patients will be accrued for this study.

Outcomes

Toxicity
Effects of treatment on response rate, time to disease progression, and survival

Outline

This is a multicenter study.

Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; and vincristine IV and bleomycin IV on day 8. Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) receive 4 courses beyond CR or PR.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Lymphoma Trials Office

Ruth Pettengell, MD, Protocol chair		Ph: 44-208-725-5454 Email: r.pettengell@sgul.ac.uk

Registry Information
Official Title		Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma
Trial Start Date		2001-10-01
Registered in ClinicalTrials.gov		NCT00032149
Date Submitted to PDQ		2002-01-23
Information Last Verified		2007-03-27

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