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Prevention study for Clonal Cytopenia of Undetermined Significance
Official title Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study
ClinicalTrials.gov ID: NCT05641831
What this study is testing
What is Canakinumab?
Canakinumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for clonal cytopenia of undetermined significance.
Also referred to as ACZ885, Ilaris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests how well canakinumab works to prevent progression to cancer in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a blood condition defined by a decrease in blood cells.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with age \>= 18 with high-risk CCUS
- Must meet ALL the following criteria:
- Unexplained, clinically meaningful cytopenias (greater than 4 months) in one or more of the following lineages: erythroid cells, neutrophils...
- Erythroid Cells:
- Hemoglobin \< 11 g/dL
You likely can't join if
- Concurrent malignancy requiring active systemic therapy
- Diagnosis of MDS or any other myeloid malignancy in the patient's lifetime
- History of Hypersensitivity to canakinumab or drug of a similar class
- Active infection requiring prompt evaluation and treatment or history of recurrent infections
- Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (via positive or indeterminate central laboratory [lab] results)
- people with active tuberculosis. In people with a history of tuberculosis but without active tuberculosis, if the results of the evaluation require...
See the full eligibility criteria
- Patients with age \>= 18 with high-risk CCUS
- Must meet ALL the following criteria:
- Unexplained, clinically meaningful cytopenias (greater than 4 months) in one or more of the following lineages: erythroid cells, neutrophils, platelets. Clinically meaningful cytopenia is institution specific and...
- Erythroid Cells:
- Hemoglobin \< 11 g/dL
- White Blood Cells:
- Absolute Neutrophil Count \ 500/microL
- Platelets:
- Platelet Count \ 50,000/microL
- MDS criteria not fulfilled
- No other evidence of hematological malignancy
- No or only mild (\< 10%) bone marrow dysplasia
- Blast cells \< 5% detected via morphologic examination of blood and/or bone marrow smears which can also be supported by flow cytometry and/or immunohistochemical studies
- Any of the following:
- Isolated somatic spliceosome mutation at any VAF (SRSF2, SF3B1, U2AF1, or ZRSR2)
- Isolated TP53 mutation greater than 5% VAF
- At least 1 mutation in TET2, DMNT3A, or ASXL1 at any VAF coupled with at least 1 other known myeloid pathogenic somatic mutation or known pathogenic germline mutation that predisposes to myeloid malignancy as determined...
- A TET2, DMNT3A, or ASXL1 greater than 10% VAF coupled with another TET2, DMNT3A, or ASXL1 greater than 10% VAF
- The presence of two or more known myeloid pathogenic somatic or germline mutations (other than TET2, ASXL1, DMNT3A, TP53, or spliceosome mutations) greater than 10% VAF
- Ability to understand and willingness to sign the written informed consent document
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Patients with a history of hypertension or active hypertension are strongly encouraged to optimize blood pressure control
- Creatinine clearance greater than 45 ml/min using Cockcroft-Gault
- Total bilirubin =\< 1.5 x ULN
- Aspartate transaminase (AST) \< 3 x ULN
- Alanine transaminase (ALT) \< 3 x ULN
- Concurrent malignancy requiring active systemic therapy
- Diagnosis of MDS or any other myeloid malignancy in the patient's lifetime
- History of Hypersensitivity to canakinumab or drug of a similar class
- Active infection requiring prompt evaluation and treatment or history of recurrent infections
- Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (via positive or indeterminate central laboratory [lab] results)
- people with active tuberculosis. In people with a history of tuberculosis but without active tuberculosis, if the results of the evaluation require treatment per local guidelines, then the treatment should be initiated...
- people with suspected or proven immunocompromised state or infections. If the results of this screening per local treatment guidelines or clinical practice require treatment for said infection then the patient is not...
- Those with any other medical condition such as active infection, treated or untreated, which in the opinion of the investigator places the subject at an unacceptable risk for participation in immunomodulatory therapy...
- Known history of testing positive for human immunodeficiency virus (HIV) infections. For countries where HIV status is mandatory: testing positive for HIV during screening using a local test.
- Allogeneic bone marrow or solid organ transplant (history of any or within a certain period of time?)
- Those requiring systemic or local treatment in doses with systemic effects e.g.:
- Prednisone \> 20 mg (or equivalent) oral or intravenous daily for \> 14 days
- Prednisone \> 5 mg and =\ 30 days
- Equivalent dose of methotrexate \> 15 mg weekly
- Note: Azathioprine is allowed. Daily glucocorticoid-replacement for conditions such as adrenal or pituitary insufficiency is allowed. Topical, inhaled or local steroid use in doses that are not considered to cause...
- Live or attenuated vaccination within 3 months prior to first dose of study drug (e.g. Measles/Mumps/Rubella [MMR], Yellow Fever, Rotavirus, Smallpox, etc.) and after initiation of canakinumab treatment
- Use of erythropoietin stimulating agents (ESA) or growth factors within four weeks prior to the start of the study
- Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. Women...
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable...
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone...
- Male sterilization (at least 6 months prior to screening). For female people on the study, the vasectomized male partner should be the sole partner for that subject
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For UK: with spermicidal foam/gel/film/cream/ vaginal suppository
- Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable how well it works (failure rate \< 1%), for example hormone vaginal ring or transdermal...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; New York, New York, United States; Columbus, Ohio, United States; Nashville, Tennessee, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.