Search / Trial NCT00002003

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

Launched by LEDERLE LABORATORIES · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Mitoxantrone Lymphoma, Large Cell Etoposide Acquired Immunodeficiency Syndrome

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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
  • 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.

About Lederle Laboratories

Lederle Laboratories, a distinguished pharmaceutical company, is recognized for its commitment to advancing healthcare through innovative research and development. With a rich history in vaccine production and biologics, Lederle Laboratories focuses on creating effective therapeutic solutions that address critical medical needs. The organization emphasizes rigorous clinical trial methodologies and adherence to regulatory standards, ensuring the safety and efficacy of its products. By fostering collaborations with healthcare professionals and research institutions, Lederle Laboratories strives to contribute significantly to the improvement of patient outcomes and public health.

Locations

New York, New York, United States

Newark, New Jersey, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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