Hematopoietic and Lymphoid Cell NeoplasmPhase 1/2NCT04532372
Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy
A Phase 1/2 study testing Best Practice and Leflunomide in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed
- What is being tested?
- Best Practice and Leflunomide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to 27 Oct 2021
- Phase
- Phase 1/2
- 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. Cognitively impaired subjects may enroll in the phase 2 portion if adequate psychosocial support is provided
- SARS-CoV-2 infection confirmed by a PCR-based test within 4 days prior to enrollment
- COVID-19 disease baseline severity of Severe according to FDA guidance, as defined by:
- Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress
- Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate >= 30 per minute, heart rate >= 125 per minute, SpO2 =< 93% on room air at sea level or partial pressure of oxygen (PaO2)/the fraction of inspired oxygen (FiO2) < 300
- Active cancer requiring systemic treatment within the last 2 years. Subjects should not have received the following therapies for their malignancy within the indicated time frames:
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- Local radiation therapy within 2 weeks prior to enrollment. If the involved field is small (single nodal area), 7 days prior to enrollment is allowed
- Chemotherapy within 2 weeks prior to enrollment
- Major surgery within 2 weeks prior to treatment
- Autologous hematopoietic stem cell infusion within 12 weeks prior to enrollment
- Antibody therapy, chimeric antigen receptor (CAR) T cells, or other biologic therapies within 12 weeks prior to enrollment
- Allogeneic hematopoietic stem cell infusion within 16 weeks prior to enrollment These time frames should be considered the minimum allowed interval and may be longer per the judgment of the investigator
- Adverse events related to prior cancer therapy must have recovered to =< grade 1 or to baseline
- Subjects must be able to forgo systemic cancer therapy for ~39 days (14 days treatment/placebo + 14 days monitoring + ~ 11 days cholestyramine)
- Absolute neutrophil cunt (ANC) >= 500/mm^3 (to be performed within 4 days prior to day 1 of protocol therapy unless otherwise stated)
- Platelets >= 25,000/mm^3 (to be performed within 4 days prior to day 1 of protocol therapy unless otherwise stated)
- Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 4 days prior to day 1 of protocol therapy unless otherwise stated)
- Aspartate aminotransferase (AST) =< 2 x ULN (to be performed within 4 days prior to day 1 of protocol therapy unless otherwise stated)
- Alanine aminotransferase (ALT) =< 2 x ULN (to be performed within 4 days prior to day 1 of protocol therapy unless otherwise stated)
- Creatinine clearance of >= 60 mL/min per 24-hour urine test or the Cockcroft-Gault formula (to be performed within 4 days prior to day 1 of protocol therapy unless otherwise stated)
- Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study until teriflunomide levels are verified to be less than 0.02 mg/L (0.02 ug/mL) for patients given leflunomide, or until unblinding occurs for those given placebo. Contraception should also be used for the duration of administration of SOC drugs during this study for the duration recommended in the prescribing information.
- Childbearing potential is defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Who cannot join
- Evidence of acute respiratory distress syndrome (ARDS), defined by at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen >= 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
- Shock (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors)
- Evidence of multi-organ dysfunction/failure
- Pre-existing acute or chronic liver disease
- Patients with indolent local malignancies or pre-malignant conditions including but not limited to:
- Smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS)
Show all 21Show fewer
- Basal or squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix or breast
- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor node metastasis [TNM] clinical staging system) or prostate cancer that is curative
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- Secondary bacterial, fungal, or viral infections that are not adequately controlled
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- If human immunodeficiency virus (HIV)-positive: CD4+ T cell count < 200
- Positive for tuberculosis antigen (e.g., T-spot test)
- Presence of liver metastasis
- Gastrointestinal (GI) malignancies associated with malabsorption and inability to take cholestyramine
- Steroids, except for low-dose replacement or high-dose for management of acute symptoms such as ARDS
- Any new immunosuppressive medication in the 4 weeks prior to enrollment, excepting agents used for treatment of COVID-19 that may also have immunosuppressive properties
- Medications that are CYP1A2 inducers, CYP2C8 inhibitors, and vitamin K antagonists, if these medications are not approved by the investigator. CYP1A2 inducers, CYP2C8 inhibitors, and vitamin K antagonists that are approved by the investigator are allowed
- Concurrent administration of live vaccines
- 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: A Phase 1/2 Trial of Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy
This phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating patients with COVID-19, and whether it is potentially effective against the disease.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the safety and tolerability of leflunomide when combined with coronavirus disease 2019 (COVID-19) standard of care (SOC) by evaluation of toxicities including: type, frequency, severity, attribution and duration. (Phase 1) II. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of leflunomide when given in combination with SOC. (Phase 1) III. Evaluate the clinical activity of leflunomide plus SOC (Arm 1) and placebo plus SOC (Arm 2) on the basis of clinical improvement (response) rate in each treatment arm, as assessed by a 7-point ordinal scale. (Phase 2/Pilot) IV. Evaluate the safety and tolerability of leflunomide plus SOC (Arm 1) and placebo plus SOC (Arm2). (Phase 2/Pilot)
SECONDARY OBJECTIVES I. Evaluate the clinical activity of leflunomide when combined with SOC on the basis of clinical improvement (response) rate. (Phase 1)
II. Estimate the following (Phase 1 and Phase 2):
IIa.Time to clinical improvement (days). IIb. Time to peripheral capillary oxygen saturation (SpO2) > 93% on room air (days).
IIc. Time to first negative SARS-CoV-2 polymerase chain reaction (PCR) (days). IId. Duration of oxygen therapy (days). IIe. Duration of hospitalization (days). IIf. Duration of mechanical ventilation. IIg. All cause mortality at day 28. III. Measure trough plasma concentrations of the active metabolite teriflunomide on days 1 through 14, day 21, and day 28, and evaluate relationships between teriflunomide levels and pharmacodynamic biomarkers (e.g., viral load, cytokines), response, safety, and concomitant medications. (Phase 1 and Phase 2)
EXPLORATORY OBJECTIVES
- Investigate inflammatory response by measuring changes before and after leflunomide treatment in:
Ia. Circulating cytokines (e.g., IL-6, IL-8, TNF-alpha, IL-12, interferons [IFNs] and granulocyte-macrophage colony-stimulating factor ([GM-CSF]).
Ib. Immune effector cell phenotype associated with monocyte, T cell, and natural killer (NK) cell activation.
II. Assess the kinetics of viral replication through serial measurements of viral load by nasopharyngeal swab and tracheal aspirates (if on ventilator and can be safely obtained).
OUTLINE: This is a phase I dose-escalation study, followed by a phase II study.
PHASE I: Patients receive leflunomide orally (PO) once daily (QD) on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I (LEFLUNOMIDE + SOC): Patients receive leflunomide PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
ARM II (PLACEBO + SOC): Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
After completion of study treatment, patients are followed up for 90 days.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed
- Being tested
- Best Practice, Leflunomide, Placebo Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care drugs
LeflunomideDrug
Also called Arava, SU101
Given PO
Placebo AdministrationDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Phase I (leflunomide, SOC) | Experimental | Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide. Receives: Other: Best Practice; Drug: Leflunomide |
| Phase II Arm I (leflunomide, SOC) | Experimental | Patients receive leflunomide PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC. Receives: Other: Best Practice; Drug: Leflunomide; Drug: Placebo Administration |
| Phase II Arm II (placebo, SOC) | Placebo comparator | Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC. Receives: Other: Best Practice; Drug: Placebo Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) (Phase 1)
MTD were based on the assessment of DLT (Dose Limiting Toxicity) during the 28-day treatment period.
Measured: From the initial study treatment (Day 0) to Day 28.
Clinical Activity (Response)(Phase 2)
Defined as a >= 2-point change in clinical status from day 1 on a 7-point ordinal scale. The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst (i.e., lowest ordinal) score from the previous day was recorded.
Measured: At day 28
Secondary outcomes (5)
Time to Clinical Activity (Response)
Defined as time from start of treatment to >= 2-point change in clinical status on a 7-point ordinal scale. The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst (i.e., lowest ordinal) score from the previous day was recorded.
Measured: Up to 28 days
Overall Survival (Phase 2)
Defined as time from start of treatment to death from any cause
Measured: Up to 90 days
Oxygen Saturation Improvement
Time from start of treatment to peripheral capillary oxygen saturation (SpO2) > 93% on room air.
Measured: Up to 90 days
Number of Participants Who Were Hospitalized
Indicate the participants who were hospitalized within first 90 days following start of treatment assessed.
Measured: Up to 90 days
Number of Participants Who Were Mechanical Ventilation Required
Indication the participants who were required mechanical ventilation at any time from start of treatment through 90 days post.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start7 Jan 2021
- Primary completion26 Aug 2021
- Study completion27 Oct 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 Hematopoietic and Lymphoid Cell NeoplasmStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase I single-arm dose-escalation design followed by a phase II randomized two-arm design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 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
- Sanjeet S Dadwal, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532372
- Sponsor's protocol ID
- 20291
- Other IDs
- NCI-2020-05746, 20291, P30CA033572
- Status last verified
- Jul 2024
- First submitted
- 25 Aug 2020
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Trial of Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy
- ClinicalTrials.gov ID
- NCT04532372
- Acronym / sponsor ID
- 20291
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating patients with COVID-19, and whether it is potentially effective against the disease.
Detailed description
PRIMARY OBJECTIVES:
- Assess the safety and tolerability of leflunomide when combined with coronavirus disease 2019 (COVID-19) standard of care (SOC) by evaluation of toxicities including: type, frequency, severity, attribution and duration. (Phase 1) II. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of leflunomide when given in combination with SOC. (Phase 1) III. Evaluate the clinical activity of leflunomide plus SOC (Arm 1) and placebo plus SOC (Arm 2) on the basis of clinical improvement (response) rate in each treatment arm, as assessed by a 7-point ordinal scale. (Phase 2/Pilot) IV. Evaluate the safety and tolerability of leflunomide plus SOC (Arm 1) and placebo plus SOC (Arm2). (Phase 2/Pilot)
SECONDARY OBJECTIVES I. Evaluate the clinical activity of leflunomide when combined with SOC on the basis of clinical improvement (response) rate. (Phase 1)
II. Estimate the following (Phase 1 and Phase 2):
IIa.Time to clinical improvement (days). IIb. Time to peripheral capillary oxygen saturation (SpO2) > 93% on room air (days).
IIc. Time to first negative SARS-CoV-2 polymerase chain reaction (PCR) (days). IId. Duration of oxygen therapy (days). IIe. Duration of hospitalization (days). IIf. Duration of mechanical ventilation. IIg. All cause mortality at day 28. III. Measure trough plasma concentrations of the active metabolite teriflunomide on days 1 through 14, day 21, and day 28, and evaluate relationships between teriflunomide levels and pharmacodynamic biomarkers (e.g., viral load, cytokines), response, safety, and concomitant medications. (Phase 1 and Phase 2)
EXPLORATORY OBJECTIVES
- Investigate inflammatory response by measuring changes before and after leflunomide treatment in:
Ia. Circulating cytokines (e.g., IL-6, IL-8, TNF-alpha, IL-12, interferons [IFNs] and granulocyte-macrophage colony-stimulating factor ([GM-CSF]).
Ib. Immune effector cell phenotype associated with monocyte, T cell, and natural killer (NK) cell activation.
II. Assess the kinetics of viral replication through serial measurements of viral load by nasopharyngeal swab and tracheal aspirates (if on ventilator and can be safely obtained).
OUTLINE: This is a phase I dose-escalation study, followed by a phase II study.
PHASE I: Patients receive leflunomide orally (PO) once daily (QD) on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I (LEFLUNOMIDE + SOC): Patients receive leflunomide PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
ARM II (PLACEBO + SOC): Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
After completion of study treatment, patients are followed up for 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Phase I single-arm dose-escalation design followed by a phase II randomized two-arm design
| Arm | Type | Receives |
|---|---|---|
| Phase I (leflunomide, SOC) | Experimental | Other: Best Practice, Drug: LeflunomidePatients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide. |
| Phase II Arm I (leflunomide, SOC) | Experimental | Other: Best Practice, Drug: Leflunomide, Drug: Placebo AdministrationPatients receive leflunomide PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC. |
| Phase II Arm II (placebo, SOC) | Placebo comparator | Other: Best Practice, Drug: Placebo AdministrationPatients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines. Cognitively impaired subjects may enroll in the phase 2 portion if adequate psychosocial support is provided
- SARS-CoV-2 infection confirmed by a PCR-based test within 4 days prior to enrollment
- COVID-19 disease baseline severity of Severe according to FDA guidance, as defined by:
- Active cancer requiring systemic treatment within the last 2 years. Subjects should not have received the following therapies for their malignancy within the indicated time frames:
- Adverse events related to prior cancer therapy must have recovered to =< grade 1 or to baseline
Key exclusion criteria (21 listed)
- Evidence of acute respiratory distress syndrome (ARDS), defined by at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen >= 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
- Shock (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors)
- Evidence of multi-organ dysfunction/failure
- Pre-existing acute or chronic liver disease
- Patients with indolent local malignancies or pre-malignant conditions including but not limited to:
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care drugs | Other | Phase I (leflunomide, SOC), Phase II Arm I (leflunomide, SOC), Phase II Arm II (placebo, SOC) |
| LeflunomideAlso: Arava, SU101Given PO | Drug | Phase I (leflunomide, SOC), Phase II Arm I (leflunomide, SOC) |
| Placebo AdministrationGiven PO | Drug | Phase II Arm I (leflunomide, SOC), Phase II Arm II (placebo, SOC) |
Primary outcome
Maximum Tolerated Dose (MTD) (Phase 1)
Time frame: From the initial study treatment (Day 0) to Day 28.
MTD were based on the assessment of DLT (Dose Limiting Toxicity) during the 28-day treatment period.
Clinical Activity (Response)(Phase 2)
Time frame: At day 28
Defined as a >= 2-point change in clinical status from day 1 on a 7-point ordinal scale. The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst (i.e., lowest ordinal) score from the previous day was recorded.
5 secondary outcomes
Time to Clinical Activity (Response)
Time frame: Up to 28 days
Overall Survival (Phase 2)
Time frame: Up to 90 days
Oxygen Saturation Improvement
Time frame: Up to 90 days
Number of Participants Who Were Hospitalized
Time frame: Up to 90 days
Number of Participants Who Were Mechanical Ventilation Required
Time frame: Up to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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.
Sanjeet S Dadwal 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 1/2 study testing Best Practice and Leflunomide in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, 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 22 inclusion and 21 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 3 Jul 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 3 Jul 2024). 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?
Maximum Tolerated Dose (MTD) (Phase 1) (time frame: From the initial study treatment (Day 0) to Day 28.). The study lists 2 primary outcomes in all. 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 3 Jul 2024.