Chronic Lymphocytic LeukemiaPhase 1AnakinraNCT04691765
Anakinra in Previously Untreated Chronic Lymphocytic Leukemia Patients
A Phase 1 study testing Kineret in people with Chronic Lymphocytic Leukemia, run by Dr. David Spaner.
Trial summary
This is a phase I trial of the IL-1 receptor antagonist anakinra in chronic lymphocytic leukemia patients who are predicted to eventually require first-line therapy based on conventional clinical criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Kineret
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Diagnosis of CLL meeting published diagnostic criteria: monoclonal B cells (either kappa or lambda light chain restricted) that are clonally co-expressing at least 1 B-cell marker (CD19 or CD20) and CD5 with prolymphocytes comprising no more than 55% of blood lymphocytes.
- Unmutated IGHV status or Rai stage 2-4 or Rai stage 0-1 with blood lymphocytes greater than 30 x 106 cells/ml or IgG less than 8 g/L.
- Not currently treated with other agents for CLL.
- Serum bilirubin, and alanine transferase less than or equal to twice the upper limit of normal.
- Platelets > or equal to 75x109/L. ANC > or equal to.75x109/L. Hemoglobin > or equal to 65 g/L
- Age>18 years old
- ECOG<2
Who cannot join
- Patients with inadequate bone marrow reserve at baseline visit as demonstrated by at least one of the following: a. ANC<.75x109/L b. platelets <75x109/L without the assistance of growth factors, thrombopoietic factors, or platelet transfusions. C. hemoglobin <65 g/L despite transfusions.
- Patients who have or have had progressive multifocal leukoencephalopathy (PML).
- Patients with clinically significant bacterial, fungal, parasitic or viral infection, which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
- Patients with known active hepatitis A, B, C or who are HIV-positive or who are at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.
- Primary immunodeficiency such as X-linked agammaglobulinemia or common variable immunodeficiency.
- Patients with active and inactive ('latent') tuberculosis infection or suspicion of active tuberculosis. If no suspicion of active tuberculosis, testing is not required.
Show all 19Show fewer
- Involvement of the central nervous system by lymphoma or leukemia.
- Richter's transformation or prolymphocytic leukemia.
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
- Use of glucocorticoids above the equivalent of 10 mg of prednisone daily within 4 weeks prior to treatment with anakinra. Patients cannot previously have taken drugs or antibodies normally used to treat CLL (eg. chlorambucil, fludarabine, cyclophosphamide, bendamustine, rituximab, ofatumumab, ibrutinib, venetoclax).
- Major surgery within 4 weeks prior to treatment.
- Patients with a history of malignancy in the past 3 years except for treated, early-stage squamous or basal cell carcinoma, carcinoma-in-situ of the cervix, or low-risk prostate cancer after curative therapy.
- History or current diagnosis of uncontrolled or significant cardiac disease, including any of the following: a. myocardial infarction within last 6 months. b. uncontrolled congestive heart failure. c. unstable angina within last 6 months. d. exertional angina. e. clinically significant (symptomatic) cardiac arrhythmias (eg. bradyarrhythmias, sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemarker).
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- Presence of severe renal function impairment (estimated creatinine clearance <30 mL/min/1.73m2).
- Patients with mild, moderate, or severe hepatic impairment or inadequate liver function defined by any of direct bilirubin, alanine amino transferase (ALT), or aspartate aminotransferase (AST)>2.5 x upper limit of normal (ULN). Patients with Child-Pugh score >5 are also excluded.
- Patients under ongoing treatment with another investigational medication or having been treated with an investigational medication within 30 days of screening or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
- Significant concurrent, uncontrolled medical condition which, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
- Subjects who are unable to comprehend or are unwilling to sign an informed consent form (ICF).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1 Trial of Anakinra in Previously Untreated Chronic Lymphocytic Leukemia Patients at Risk for Progression
This is a phase I trial of the IL-1 receptor antagonist anakinra in chronic lymphocytic leukemia patients who are predicted to eventually require first-line therapy based on conventional clinical criteria. Three groups of 4 patients will be injected subcutaneously with either 100 mg daily or 100 mg twice daily or 200 mg twice daily for 7 cycles of 4 weeks each to determine the dose-limiting toxicity of anakinra in this population. Clinical responses will be determined by conventional IWCLL criteria. It is hoped anakinra will prevent disease progression with little toxicity. The study is anticipated to be completed within a year.
Read the detailed description
To avoid unnecessary toxicity from treatments that do not cure, patients with chronic lymphocytic leukemia (CLL) patients are traditionally observed until they develop symptoms that justify first-line therapy. This period of observation is called "watch and wait". Treatment of symptomatic CLL has improved significantly with new drugs such as ibrutinib that provide disease control previously impossible with standard chemotherapy. Unfortunately, these drugs rarely cure and outcomes are poor once they stop working. There is a need for strategies to prevent disease progression during "watch and wait" in order to extend survival and improve the lives of CLL patients.
It has been found that CLL cells from many patients spontaneously make the cytokine interleukin-1 (IL-1). When IL-1 is blocked by the IL-1 receptor antagonist anakinra, CLL cells release high amounts of type 1 interferon (IFN). Since IFN produced at sufficient levels for appropriate times activates immune responses that may prevent progression of cancer and anakinra has a favorable toxicity profile, the hypothesis of this trial is that anakinra administered in the "watch and wait" period may clear CLL cells before they can cause symptoms.
The hypothesis will be addressed in a phase 1 clinical trial. The primary objective is to determine the dose-limiting toxicity (DLT) of anakinra, which has not been established previously in this patient population. The secondary objectives are to determine the effect on disease burden. Anakinra will be provided by Sobi and clinical trial costs supported by the Sunnybrook hematology site group. The trial will involve 3 cohorts of 4 patients in a standard phase 1 design. Eligible patients will be on "watch and wait" but expected to inevitably require treatment as predicted by unmutated IGHV status, presence of lymphadenopathy or splenomegaly, circulating CLL counts greater than 30x106 cells/ml, or IgG levels less than 8 g/L. Cohorts will be treated with 100 mg subcutaneously (SC BID) daily, the dose approved for rheumatoid arthritis, 100 mg SC BID, or 200 mg BID, to approximate doses for genetic inflammopathies. Anakinra will be given daily for seven 4-week cycles based on experience with other immunomodulatory drugs that suggest an average time to best response is ~7 months. Responses will be determined by conventional criteria based on decreases in circulating CLL cell numbers and radiologic measurements of lymphadenopathy. Anakinra will be considered ineffective if no clinical responses are observed after 7 cycles. Based on Gehan criteria, a new drug must show activity in at least 1/13 patients to justify further testing.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Kineret
- Keywords
- CLL, Chronic Lymphocytic Leukemia, Anakinra, type 1 interferon, IFN, dose-limiting toxicity, Kineret
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KineretDrug
Also called Anakinra
escalating doses of drug will be administered to 3 groups of 4 patients for 7 months
| Study group | Role | What they receive |
|---|---|---|
| 100 mg SC | Experimental | 100 mg of Kineret (anakinra) will be administered sub-subcutaneously once a day for 28 days (1 cycle) with a maximum of 7 cycles (28 weeks of treatment) Receives: Drug: Kineret |
| 100 mg SC BID | Experimental | 100 mg of Kineret (anakinra) will be administered sub-subcutaneously twice a day for 28 days (1 cycle) with a maximum of 7 cycles (28 weeks of treatment) Receives: Drug: Kineret |
| 200 mg SC BID | Experimental | 200 mg of Kineret (anakinra) will be administered sub-subcutaneously twice a day for 28 days (1 cycle) with a maximum of 7 cycles (28 weeks of treatment) Receives: Drug: Kineret |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and dose limiting toxicities of anakinra in CLL patients
The primary endpoints relate to safety and tolerability of anakinra in this patient, including numbers of patients with treatment-related adverse events (AEs) as assessed by CTCAE v4.0
Measured: 1 year
Secondary outcomes (1)
Efficacy of anakinra in CLL patients
Efficacy, defined as the proportion of patients with complete response (CR) or proportion of patients with partial response as defined by the NCI-WG guidelines on CLL.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 May 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The trial will involve 12 patients in a standard dose escalation design. The first cohort of 4 patients will start at 100 mg SC daily, the dose approved for rheumatoid arthritis. If no dose limiting toxicities are experienced by these patients during the first cycle of treatment, then the next cohort of up to 4 patients will be treated at 100 mg SC twice daily (BID). The third cohort of up to 4 patients will be treated at 200 mg BID SC daily, to approximate doses used to treat inflammopathies such as Cryopyrin-Associated Periodic Syndromes.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. David Spaner
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Responsible party
- Sponsor-investigator, Dr. David Spaner, Sunnybrook Health Sciences Centre
- Investigators
- David Spaner, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691765
- Sponsor's protocol ID
- Anakinra
- Acronym
- Anakinra
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo Y, Su B, Hung V, Luo Y, Shi Y, Wang G, de Graaf D, Dinarello CA, Spaner DE. IL-1 receptor antagonism reveals a yin-yang relationship between NFkappaB and interferon signaling in chronic lymphocytic leukemia. Proc Natl Acad Sci U S A. 2024 Aug 13;121(33):e2405644121. doi: 10.1073/pnas.2405644121. Epub 2024 Aug 9.
PubMed 39121163
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of Anakinra in Previously Untreated Chronic Lymphocytic Leukemia Patients at Risk for Progression
- ClinicalTrials.gov ID
- NCT04691765
- Acronym / sponsor ID
- Anakinra / Anakinra
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL, Chronic Lymphocytic Leukemia, Anakinra, type 1 interferon, IFN, dose-limiting toxicity, Kineret
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Dr. David SpanerUniversity, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Study start
- 1 May 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I trial of the IL-1 receptor antagonist anakinra in chronic lymphocytic leukemia patients who are predicted to eventually require first-line therapy based on conventional clinical criteria. Three groups of 4 patients will be injected subcutaneously with either 100 mg daily or 100 mg twice daily or 200 mg twice daily for 7 cycles of 4 weeks each to determine the dose-limiting toxicity of anakinra in this population. Clinical responses will be determined by conventional IWCLL criteria. It is hoped anakinra will prevent disease progression with little toxicity. The study is anticipated to be completed within a year.
Detailed description
To avoid unnecessary toxicity from treatments that do not cure, patients with chronic lymphocytic leukemia (CLL) patients are traditionally observed until they develop symptoms that justify first-line therapy. This period of observation is called "watch and wait". Treatment of symptomatic CLL has improved significantly with new drugs such as ibrutinib that provide disease control previously impossible with standard chemotherapy. Unfortunately, these drugs rarely cure and outcomes are poor once they stop working. There is a need for strategies to prevent disease progression during "watch and wait" in order to extend survival and improve the lives of CLL patients.
It has been found that CLL cells from many patients spontaneously make the cytokine interleukin-1 (IL-1). When IL-1 is blocked by the IL-1 receptor antagonist anakinra, CLL cells release high amounts of type 1 interferon (IFN). Since IFN produced at sufficient levels for appropriate times activates immune responses that may prevent progression of cancer and anakinra has a favorable toxicity profile, the hypothesis of this trial is that anakinra administered in the "watch and wait" period may clear CLL cells before they can cause symptoms.
The hypothesis will be addressed in a phase 1 clinical trial. The primary objective is to determine the dose-limiting toxicity (DLT) of anakinra, which has not been established previously in this patient population. The secondary objectives are to determine the effect on disease burden. Anakinra will be provided by Sobi and clinical trial costs supported by the Sunnybrook hematology site group. The trial will involve 3 cohorts of 4 patients in a standard phase 1 design. Eligible patients will be on "watch and wait" but expected to inevitably require treatment as predicted by unmutated IGHV status, presence of lymphadenopathy or splenomegaly, circulating CLL counts greater than 30x106 cells/ml, or IgG levels less than 8 g/L. Cohorts will be treated with 100 mg subcutaneously (SC BID) daily, the dose approved for rheumatoid arthritis, 100 mg SC BID, or 200 mg BID, to approximate doses for genetic inflammopathies. Anakinra will be given daily for seven 4-week cycles based on experience with other immunomodulatory drugs that suggest an average time to best response is ~7 months. Responses will be determined by conventional criteria based on decreases in circulating CLL cell numbers and radiologic measurements of lymphadenopathy. Anakinra will be considered ineffective if no clinical responses are observed after 7 cycles. Based on Gehan criteria, a new drug must show activity in at least 1/13 patients to justify further testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The trial will involve 12 patients in a standard dose escalation design. The first cohort of 4 patients will start at 100 mg SC daily, the dose approved for rheumatoid arthritis. If no dose limiting toxicities are experienced by these patients during the first cycle of treatment, then the next cohort of up to 4 patients will be treated at 100 mg SC twice daily (BID). The third cohort of up to 4 patients will be treated at 200 mg BID SC daily, to approximate doses used to treat inflammopathies such as Cryopyrin-Associated Periodic Syndromes.
| Arm | Type | Receives |
|---|---|---|
| 100 mg SC | Experimental | Drug: Kineret100 mg of Kineret (anakinra) will be administered sub-subcutaneously once a day for 28 days (1 cycle) with a maximum of 7 cycles (28 weeks of treatment) |
| 100 mg SC BID | Experimental | Drug: Kineret100 mg of Kineret (anakinra) will be administered sub-subcutaneously twice a day for 28 days (1 cycle) with a maximum of 7 cycles (28 weeks of treatment) |
| 200 mg SC BID | Experimental | Drug: Kineret200 mg of Kineret (anakinra) will be administered sub-subcutaneously twice a day for 28 days (1 cycle) with a maximum of 7 cycles (28 weeks of treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of CLL meeting published diagnostic criteria: monoclonal B cells (either kappa or lambda light chain restricted) that are clonally co-expressing at least 1 B-cell marker (CD19 or CD20) and CD5 with prolymphocytes comprising no more than 55% of blood lymphocytes.
- Unmutated IGHV status or Rai stage 2-4 or Rai stage 0-1 with blood lymphocytes greater than 30 x 106 cells/ml or IgG less than 8 g/L.
- Not currently treated with other agents for CLL.
- Serum bilirubin, and alanine transferase less than or equal to twice the upper limit of normal.
- Platelets > or equal to 75x109/L. ANC > or equal to.75x109/L. Hemoglobin > or equal to 65 g/L
Key exclusion criteria (19 listed)
- Patients with inadequate bone marrow reserve at baseline visit as demonstrated by at least one of the following: a. ANC<.75x109/L b. platelets <75x109/L without the assistance of growth factors, thrombopoietic factors, or platelet transfusions. C. hemoglobin <65 g/L despite transfusions.
- Patients who have or have had progressive multifocal leukoencephalopathy (PML).
- Patients with clinically significant bacterial, fungal, parasitic or viral infection, which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
- Patients with known active hepatitis A, B, C or who are HIV-positive or who are at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.
- Primary immunodeficiency such as X-linked agammaglobulinemia or common variable immunodeficiency.
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 |
|---|---|---|
| KineretAlso: Anakinraescalating doses of drug will be administered to 3 groups of 4 patients for 7 months | Drug | 100 mg SC, 100 mg SC BID, 200 mg SC BID |
Primary outcome
Safety and dose limiting toxicities of anakinra in CLL patients
Time frame: 1 year
The primary endpoints relate to safety and tolerability of anakinra in this patient, including numbers of patients with treatment-related adverse events (AEs) as assessed by CTCAE v4.0
1 secondary outcome
Efficacy of anakinra in CLL patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Derived from this study: PubMed 39121163Luo Y, Su B, Hung V, Luo Y, Shi Y, Wang G, de Graaf D, Dinarello CA, Spaner DE. IL-1 receptor antagonism reveals a yin-yang relationship between NFkappaB and interferon signaling in chronic lymphocytic leukemia. Proc Natl Acad Sci U S A. 2024 Aug 13;121(33):e2405644121. doi: 10.1073/pnas.2405644121. Epub 2024 Aug 9.
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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.
David Spaner, MD principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kineret in people with Chronic Lymphocytic Leukemia, run by Dr. David Spaner.
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 7 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Gallagher, BSc (416-480-6100 ext. 7382, jennifer.gallagher@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and dose limiting toxicities of anakinra in CLL patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691765, which also lists 1 linked publication.
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 19 Mar 2021.