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Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma


OBJECTIVES:

- Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's
lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.

- Determine the toxicity of this regimen in these patients.

- Determine the time to progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral
prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6
courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve
complete response (CR) receive 2 additional courses of chemotherapy after CR.

Patients are followed every 1-2 months.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL)

- Previously untreated

- More than 1 of the following criteria:

- Prior diagnosis of AIDS

- ECOG performance status 3-4

- CD4 count less than 100/mm3

- No primary cerebral lymphoma

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- See Disease Characteristics

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for HIV-NHL

- At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS)

Endocrine therapy:

- Not specified

Radiotherapy:

- Prior radiotherapy for HIV-NHL allowed

- At least 1 year since prior radiotherapy for KS

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ruth Pettengell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. George's Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000069238

NCT ID:

NCT00031902

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related diffuse large cell lymphoma
  • AIDS-related immunoblastic large cell lymphoma
  • AIDS-related small noncleaved cell lymphoma
  • AIDS-related diffuse mixed cell lymphoma
  • AIDS-related diffuse small cleaved cell lymphoma
  • AIDS-related lymphoblastic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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