BridgeMD
New treatment option for Chronic Myelomonocytic Leukemia
Official title A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
ClinicalTrials.gov ID: NCT04239157
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 chronic myelomonocytic leukemia.
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 studies how well canakinumab works for the treatment of low- or intermediate-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. Canakinumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 18 years as MDS and CCUS are very rare conditions in the pediatric setting.
- Cohorts 1-3: Diagnosis of MDS according to WHO 2016 classification and low or intermediate-1 risk by IPSS or IPSS-R with a score of ≤ 3.5.
- Cohort 4: Diagnosis of CCUS defined as:
- Presence of a somatic pathogenic variant associated with hematological malignancy without morphological evidence of myelodysplasia
- Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant
You likely can't join if
- Active infection not adequately responding to appropriate antibiotics.
- Prior treatment with IL-1/IL-1r inhibitors
- Absolute neutrophil count (ANC) \<0.5x109 k/ul; colony-stimulating factors can be administered prior to study drug initiation.
- Female participants who are pregnant or lactating.
- Participants with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual...
- Female participants with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test...
See the full eligibility criteria
- Age ≥ 18 years as MDS and CCUS are very rare conditions in the pediatric setting.
- Cohorts 1-3: Diagnosis of MDS according to WHO 2016 classification and low or intermediate-1 risk by IPSS or IPSS-R with a score of ≤ 3.5.
- Cohort 4: Diagnosis of CCUS defined as:
- Presence of a somatic pathogenic variant associated with hematological malignancy without morphological evidence of myelodysplasia
- Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant
- Bone marrow aspirate excluding hematological malignancy and MDS
- Presence of a cytopenia for \>30 days. Cytopenia will be defined using accepted CHRS (Clonal Hematopoiesis Risk Score) criteria (Weeks et al, NEJM Evidence in press): ANC \<1.8 or hgb \<12 in females and \<13 in males...
- Cohort 1: Participants need to have not responded to prior therapy with ESAs or hypomethylating agents (HMAs). These could include azacitidine, decitabine, SGI-110, ASTX727, or CC-486. Patients will need to have...
- Cohort 1: Hemoglobin \<10g/dL with symptomatic anemia or transfusion dependency defined as the need for prior transfusion in the past 8 weeks for a hemoglobin level less than 8g/dl.
- Cohort 2: Transfusion dependency defined as the need for prior transfusion in the past 8 weeks of (1) at least 2 units of PRBC for a hemoglobin level less than 8g/dl or symptomatic anemia (hemoglobin \<10g/dL), or (2)...
- Participants (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to...
- Adequate hepatic function with total bilirubin \</=3 x ULN, AST or ALT \</= 3xULN.
- Serum creatinine clearance \>30mL/min and no end/stage renal disease (using Cockcroft-Gault).
- ECOG performance status \</=2.
- Active infection not adequately responding to appropriate antibiotics.
- Prior treatment with IL-1/IL-1r inhibitors
- Absolute neutrophil count (ANC) \<0.5x109 k/ul; colony-stimulating factors can be administered prior to study drug initiation.
- Female participants who are pregnant or lactating.
- Participants with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control...
- Female participants with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.
- History of an active malignancy within the past 2 years prior to study entry, with the exception of: a. Adequately treated in situ carcinoma of the cervix uteri b. Adequately treated basal cell carcinoma or localized...
- Participants receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment).
- Known history of testing positive for Human Immunodeficiency Virus (HIV) infections. Participants requiring systemic steroids, methotrexate or other immunosuppressive drugs will not be included in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, 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 Houston, 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.