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

NCT04463615 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 19606NCI-2020-02973P30CA033572
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Lymphoproliferative Disorder; Refractory Lymphoproliferative Disorder

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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.

  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.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Treatment (leflunomide)

EXPERIMENTAL

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.

Drug: Leflunomide

Interventions

Leflunomide DRUG

Given PO

Also known as: Arava, SU101

Treatment (leflunomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Aspartate aminotransferase (AST) =\< 2.0 x ULN (within 21 days prior to Day 1 of protocol therapy)
• Alanine aminotransferase (ALT) =\< 2.0 x ULN (within 21 days prior to day 1 of protocol therapy)
• Creatinine clearance of \>= 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 21 days prior to day 1 of protocol therapy)
• Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 21 days prior to day 1 of protocol therapy)
• If positive, hepatitis C RNA quantitation must be performed

You may not qualify if:

• 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
• Prostate cancer \< Gleason grade 6 with a stable prostate specific antigen (PSA)
• Successfully treated in situ carcinoma of the breast
• Clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or the patient's ability to give informed consent
• Pregnant women and women who are lactating. Leflunomide has potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is enrolled on this study
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Lymphoproliferative Disorders

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Christiane Querfeld
• Organization: City of Hope Medical Center

cquerfeld@coh.org

6263598111

Study Officials

• Christiane Querfeld

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: May 5, 2021
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-11

Locations

US (1)