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CompletedNCT00002003Updated Jun 24, 2005

Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas

A Phase 2 interventional study of Mitoxantrone hydrochloride and Etoposide in Lymphoma, Non-Hodgkin and HIV Infections, sponsored by Lederle Laboratories. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Lederle Laboratories · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.

02

Conditions studied

  • Lymphoma, Non-Hodgkin
  • HIV Infections

Keywords

  • Mitoxantrone
  • Lymphoma, Large-Cell
  • Etoposide
  • Acquired Immunodeficiency Syndrome
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

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Lead sponsor

Lederle Laboratories is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients must have the following:

  • Positive HIV antibody, positive HIV culture or antigen capture, or prior diagnosis of AIDS by the CDC criteria.
  • Diagnosis by pathological examination of large cell or immunoblastic lymphoma within measurable or evaluable disease.
  • Pneumocystis carinii pneumonia (PCP) prophylaxis during the course of the study.
  • Signed written informed consent.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
  • Stage IE Central Nervous System lymphomas.

Patients with the following are excluded:

  • More than one previous treatment for lymphoma.
  • Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
  • Conditions that preclude obtaining an informed consent.
  • Not accessible for scheduled treatment visits or follow-up.
  • Stage IE Central Nervous System (CNS) lymphomas.

Prior Medication:

Excluded within 2 weeks of study entry:

  • Zidovudine.
  • Excluded:
  • Doxorubicin dosing = or > 300 mg/m2.

Prior Treatment:

Excluded:

  • Received more than one previous treatment regimen for lymphoma.

Required:

  • Prophylactic treatment for Pneumocystis carinii pneumonia (PCP) prophylaxis.
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • DrugMitoxantrone hydrochloride
  • DrugEtoposide
06

Study locations

3 sites
  • UMDNJ - New Jersy Med School
    Newark, New Jersey 071032714, United States
  • New York Univ Med Ctr
    New York, New York 10016, United States
  • Saint Luke's - Roosevelt Hosp Ctr
    New York, New York 10019, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002003
Lead sponsor
Lederle Laboratories
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 1992. You cannot join it, but the record below documents what was studied.

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