Pilot Trial of Leflunomide in Patients With CD30+ Lymphoproliferative Disorders
Overview
- Phase
- Phase 2
- Intervention
- Leflunomide
- Conditions
- Recurrent Lymphoproliferative Disorder
- Sponsor
- City of Hope Medical Center
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Overall Response Rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Documented informed consent of the participant and/or legally authorized representative
- •Assent, when appropriate, will be obtained per institutional guidelines
- •Patients must have a life expectancy of \> 3 months
- •Eastern Cooperative Oncology Group (ECOG) =\< 2
- •Patients must have a diagnosis of cutaneous CD30+ LYPD
- •Patients must be relapsed or are refractory to at least 1 prior line of therapy
- •At least 2 weeks from prior therapy to time of start of treatment. Prior therapy includes steroids (except prednisone or equivalent - up to 10 mg/day is allowed)
- •Absolute neutrophil count (ANC) \>= 1000/mm\^3 (within 21 days prior to day 1 of protocol therapy). NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
- •Platelets \>= 50,000/mm\^3 (within 21 days prior to day 1 of protocol therapy). NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
- •Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (within 21 days prior to day 1 of protocol therapy)
Exclusion Criteria
- •Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period
- •Current or planned growth factor or transfusion support. If growth factor or transfusion support is provided between screening and start of treatment, the participant will no longer be eligible
- •Prior allogeneic transplant
- •Acute active infection requiring systemic therapy within 2 weeks prior to enrollment
- •Known history of hepatitis B or hepatitis C infection
- •Known HIV infection
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to leflunomide or cholestyramine
- •Non-hematologic malignancy within the past 3 years aside from the following exceptions:
- •Adequately treated basal cell or squamous cell skin cancer
- •Carcinoma in situ of the cervix
Arms & Interventions
Treatment (leflunomide)
Patients receive leflunomide PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
Intervention: Leflunomide
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression.
Defined as the proportion of patients with a documented response (complete response \[CR\] or partial \[PR\]) any time during study treatment. Response will be categorized by modified severity weighted assessment tool (mSWAT). Will be calculated along with the Clopper Pearson binomial 95% exact confidence intervals. The treatment response was assessed after each 28-day cycle treatment.
Secondary Outcomes
- Complete Response Rate(Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and was off treatment on Day 14 of the second cycle due to disease progression.)