NCT04463615

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

Pilot Trial of Leflunomide in Patients With CD30+ Lymphoproliferative Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Lymphoproliferative Disorder
• Refractory Lymphoproliferative Disorder

Interventions

Type	Name	Description
DRUG	Leflunomide	Given PO

Timeline

• Start date: 2021-05-05
• Primary completion: 2021-07-28
• Completion: 2021-07-28
• First posted: 2020-07-09
• Last updated: 2023-12-05
• Results posted: 2023-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study