BridgeMD
A Phase II, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Canakinumab for the Treatment of Anemia in Patients with IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes or MDS/MPN
EU CTIS ID: 2024-515886-33-00
What this study is testing
To study the erythroid response rate (HI-E) of canakinumab in patients with IPSS-R very low, low, or intermediate risk MDS or MDS/MPN.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cytomorphology based confirmed diagnosis of lower-risk MDS or MDS/MPN including MDS/MPN-RS-T, MDS/MPNu, aCML or CMML (as per the World Health Organization [WHO] 2016 classification)
- IPSS-R up to 3.5: very low/low/intermediate risk disease (MDS); MDS/MPN < 10% bone marrow blasts; CPSS-Score low/intermediate for CMML
- Symptomatic anemia (based on complete Hb time course and transfusion history)
- Relapsed / refractory / intolerant / ineligible (sEPO ≥ 200 U/L) to ESA treatment
- Age ≥ 18 years
- Written informed consent
You likely can't join if
- Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
- Active second malignancy
- Prior or concomitant treatment with anticancer medications or disease modifying agents
- Previously treated with canakinumab
- Prior allogeneic or autologous stem cell transplant
- Known history of diagnosis of AML
See the full eligibility criteria
- Cytomorphology based confirmed diagnosis of lower-risk MDS or MDS/MPN including MDS/MPN-RS-T, MDS/MPNu, aCML or CMML (as per the World Health Organization [WHO] 2016 classification)
- IPSS-R up to 3.5: very low/low/intermediate risk disease (MDS); MDS/MPN < 10% bone marrow blasts; CPSS-Score low/intermediate for CMML
- Symptomatic anemia (based on complete Hb time course and transfusion history)
- Relapsed / refractory / intolerant / ineligible (sEPO ≥ 200 U/L) to ESA treatment
- Age ≥ 18 years
- Written informed consent
- Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
- Active second malignancy
- Prior or concomitant treatment with anticancer medications or disease modifying agents
- Previously treated with canakinumab
- Prior allogeneic or autologous stem cell transplant
- Known history of diagnosis of AML
- Severe neutropenia (ANC 0.5 Gpt/L)
- Severe thrombocytopenia (PLT <30 Gpt/L)
- Serum creatinine > 1.5x ULN OR measured or calculated creatinine clearance < 40 ml/min
- AST or ALT ≥ 3.0 x ULN
- ECOG > 2
- Total bilirubin ≥ 2.0 x ULN
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.