Recurrent Lymphoproliferative DisorderPhase 2NCT04463615
Leflunomide for the Treatment of Relapsed or Refractory CD30+ Lymphoproliferative Disorders
A Phase 2 study testing Leflunomide in people with Recurrent Lymphoproliferative Disorder and Refractory Lymphoproliferative Disorder, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Lymphoproliferative Disorder, Refractory Lymphoproliferative Disorder
- What is being tested?
- Leflunomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 28 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Meets other institutional and federal requirements for infectious disease titer requirements. Note infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
- Negative for tuberculosis antigen (e.g. T-Spot test)
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 21 days prior to day 1 of protocol therapy). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential* to use an effective method of birth control (hormonal or barrier method of birth control or abstinence) or abstain from heterosexual activity for the course of the study through at least three months after the last dose of protocol therapy. The effects of study treatment on a developing fetus have the potential for teratogenic or abortifacient effects. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 2 years (women only)
Who cannot join
- 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
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- 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
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Pilot Trial of Leflunomide in Patients With CD30+ Lymphoproliferative Disorders
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate overall response rate of leflunomide treatment.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Leflunomide
- Medical subject headings
- Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeflunomideDrug
Also called Arava, SU101
Given PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Leflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Defined as the proportion of patients with a documented CR any time during study treatment. Response will be assessed by 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start5 May 2021
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Lymphoproliferative DisorderStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christiane Querfeld, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463615
- Sponsor's protocol ID
- 19606
- Other IDs
- NCI-2020-02973, 19606, P30CA033572
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2020
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Leflunomide in Patients With CD30+ Lymphoproliferative Disorders
- ClinicalTrials.gov ID
- NCT04463615
- Acronym / sponsor ID
- 19606
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 May 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate overall response rate of leflunomide treatment.
SECONDARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (leflunomide) | Experimental | Drug: LeflunomidePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Documented informed consent of the participant and/or legally authorized representative
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeflunomideAlso: Arava, SU101Given PO | Drug | Treatment (leflunomide) |
Primary outcome
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.
1 secondary outcome
Complete 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 was off treatment on Day 14 of the second cycle due to disease progression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Querfeld principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leflunomide in people with Recurrent Lymphoproliferative Disorder and Refractory Lymphoproliferative Disorder, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.