Leflunomide for the Treatment of Relapsed or Refractory CD30+ Lymphoproliferative Disorders

  • STATUS
    Not Recruiting
  • End date
    Jul 16, 2023
  • participants needed
    12
  • sponsor
    City of Hope Medical Center
Updated on 13 June 2022

Summary

This trial studies how well leflunomide works for the treatment of patients with CD30+ lymphoproliferative disorders that have come back (relapsed) or do not respond to treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Description

PRIMARY OBJECTIVE:

I. To evaluate overall response rate of leflunomide treatment.

SECONDARY OBJECTIVES:

I. To assess complete response rate and duration of response of leflunomide treatment.

II. To assess toxicities of leflunomide treatment. III. To assess disease status by the CAILS (composite assessment of index lesion severity).

EXPLORATORY OBJECTIVE:

I. To generate a preliminary ribonucleic acid (RNA) signature associated with response of CD30+ lymphoproliferative disorders (LYPDs) cells to leflunomide.

OUTLINE

Patients receive leflunomide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 12 months.

Details
Condition Recurrent Lymphoproliferative Disorder, Refractory Lymphoproliferative Disorder
Treatment leflunomide
Clinical Study IdentifierNCT04463615
SponsorCity of Hope Medical Center
Last Modified on13 June 2022

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