BridgeMD
A Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) plus BSC versus Placebo plus BSC in Participants with IPSS-R Low- or Intermediate-risk MDS
EU CTIS ID: 2022-500479-29-00
What this study is testing
For Part I (Phase 2) The primary objective is to evaluate the safety and efficacy (CR within 6 cycles) of 2 Oral-Aza dose regimens, and to recommend the optimal dose for the Phase 3 study (RP3D) based on the totality of safety, efficacy, PK, and PD data. For Part II (Phase 3) The primary objective is to evaluate the CR (as defined in the statistical consideration section) within 6 cycles for both study arms
- Phase II and Phase III (Integrated)
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
- Male and female participants must be ≥ 18 years of age at the time of signing the informed consent.
- Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets IPSS-R classification of low- or intermediate-risk disease (low IPSS-R score: > 1.5 and ≤ 3.0; intermediate IPSS-R score: > 3.0 and ≤ 4.5). For participants in South Korea, the IPSS-R score for inclusion in Part II (Phase 3) is > 1.5 and ≤ 3.5. MDS subtypes may include (MDS with single lineage dysplasia [MDS-SLD], MDS with multilineage dysplasia [MDS-MLD], MDS with ring sideroblasts [MDS-RS] [SLD or MLD], MDS unclassifiable [MDS-U], MDS with excess blasts-1 [MDS-EB1], MDS with deletion of 5q [MDS-del(5q)], therapy related myeloid neoplasm [t-MN]). MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results
- Participant has at least 1 cytopenia (anemia, thrombocytopenia, or neutropenia) meeting one of the protocol defined criteria.
- Have an Eastern Cooperative Oncology Group ECOG performance status of 0, 1, or 2.
You likely can't join if
- Participants with prior malignancies must have 1) an expected median life expectancy of at least 12 months at the time of inclusion and 2) no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy).
- Hypoplastic MDS with a marrow cellularity of ≤ 10%
- Participants diagnosed with MDS-EB2
- Overlap syndrome (MDS/MPN), CMML, atypical chronic myeloid leukemia (CML), unclassifiable myeloproliferative disorder (MPD), and MDS with moderate to extensive marrow fibrosis (Grade 2 or 3).
- Significant active cardiac disease within the previous 6 months.
- Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection, or evidence of active Hepatitis B Virus (HBV)
See the full eligibility criteria
- Male and female participants must be ≥ 18 years of age at the time of signing the informed consent.
- Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets IPSS-R classification of low- or intermediate-risk disease (low IPSS-R score: > 1.5 and ≤ 3.0; intermediate IPSS-R score: > 3.0 and ≤ 4.5). For participants in South Korea, the IPSS-R score for inclusion in Part II (Phase 3) is > 1.5 and ≤ 3.5. MDS subtypes may include (MDS with single lineage dysplasia [MDS-SLD], MDS with multilineage dysplasia [MDS-MLD], MDS with ring sideroblasts [MDS-RS] [SLD or MLD], MDS unclassifiable [MDS-U], MDS with excess blasts-1 [MDS-EB1], MDS with deletion of 5q [MDS-del(5q)], therapy related myeloid neoplasm [t-MN]). MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results
- Participant has at least 1 cytopenia (anemia, thrombocytopenia, or neutropenia) meeting one of the protocol defined criteria.
- Have an Eastern Cooperative Oncology Group ECOG performance status of 0, 1, or 2.
- Participants with prior malignancies must have 1) an expected median life expectancy of at least 12 months at the time of inclusion and 2) no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy).
- Hypoplastic MDS with a marrow cellularity of ≤ 10%
- Participants diagnosed with MDS-EB2
- Overlap syndrome (MDS/MPN), CMML, atypical chronic myeloid leukemia (CML), unclassifiable myeloproliferative disorder (MPD), and MDS with moderate to extensive marrow fibrosis (Grade 2 or 3).
- Significant active cardiac disease within the previous 6 months.
- Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection, or evidence of active Hepatitis B Virus (HBV)
- Participants with an absolute neutrophil count (ANC) of less than 0.5 × 109/L within a week (7 days) of randomization or other laboratory abnormalities as defined in Section 6.2.
- Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent.
- Prior treatment with lenalidomide unless the participant received the last dose ≥ 8 weeks prior to randomization.
- Use of excluded treatment within 35 days prior to randomization as defined in Section 6.2
- Use of corticosteroid for any medical condition with an average daily dose above 100mg of hydrocortisone or equivalent 1 week prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- China
- Japan
- United States
- Korea, Republic of
- Australia
- Hong Kong
- Argentina
- Switzerland
- Canada
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; China; Japan; United States; Korea, Republic of; Australia and 4 more location(s). 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 EU CTIS; the study team decides eligibility.