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A phase 2/3, multi-center, study of L-Annamycin in combination with cytarabine vs. placebo in combination with cytarabine as second line therapy in adult subjects with refractory/relapsed AML
EU CTIS ID: 2024-518359-47-00
What this study is testing
Part A: To identify the optimal dosage regimen of L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed acute myeloid leukemia (AML) as measured by rate of complete remission (CR) after one treatment cycle. Part B: To confirm the superior efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by rate of CR after one treatment cycle.
- 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
- 1. Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) (Arber et al. 2022) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML (Döhner et al. 2022). The tests and procedures used to establish the diagnosis of AML should be consistent with the ELN’s 2022 recommendations (i.e., Döhner et al. 2022 Table 4 and crossreferenced Table 5)
- 10. For women of childbearing potential (WCBP): Must have a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test within 72 hours prior to the first randomized dose of study drug.
- 11. For WCBP: Must agree to not donate ova and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug.
- 12. For males with partners who are WCBP: Must agree to not donate sperm and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug.
- 2. Has refractory/relapsed AML after having received only one prior line of therapy, as defined by the protocol
- 3. Between 18 and 80 years of age (inclusive) at the time of signing the ICF
You likely can't join if
- 1. Has prior or current diagnosis of acute promyelocytic leukemia (APL) or MDS/AML (as defined in Döhner et al. 2022 Table 1).
- 7. Has any condition that, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study
- 8. Has received prior treatment with L-asparaginase
- 11. Has received a total cumulative prior anthracycline dose of > 300 mg/m2 (daunorubicin equivalent dose).
- 9. Pregnant or breastfeeding
- 12. Has relapsed or refractory AML with a FLT3 mutation, unless resides in a country where gilteritinib is not available
See the full eligibility criteria
- 1. Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) (Arber et al. 2022) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML (Döhner et al. 2022). The tests and procedures used to establish the diagnosis of AML should be consistent with the ELN’s 2022 recommendations (i.e., Döhner et al. 2022 Table 4 and crossreferenced Table 5)
- 10. For women of childbearing potential (WCBP): Must have a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test within 72 hours prior to the first randomized dose of study drug.
- 11. For WCBP: Must agree to not donate ova and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug.
- 12. For males with partners who are WCBP: Must agree to not donate sperm and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug.
- 2. Has refractory/relapsed AML after having received only one prior line of therapy, as defined by the protocol
- 3. Between 18 and 80 years of age (inclusive) at the time of signing the ICF
- 4. Has received no chemotherapy, radiation, or major surgery within 2 weeks prior to the first randomized dose of study drug or has recovered from the toxic side effects of that therapy. Hydroxyurea to control white blood cell (WBC) count, supportive measures, and prophylaxes as required under the protocol will be allowed. Treatment of opportunistic or other infections with antibiotics, antifungals, and/or antiviral agents, including therapy for meningeal disease (i.e., intrathecal chemotherapy), per institutional standards of care will be allowed during this period, as long as the symptoms of infection have resolved by 1 week prior to the first dose of randomized study drug
- 5. Has received no investigational therapy within 4 weeks prior to the first randomized dose of study drug
- 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening.
- 7. Has a life expectancy of greater than six weeks at screening
- 8. Has adequate laboratory results at screening, as per protocol
- 9. Can understand and sign the ICF, can communicate with the PI, and can understand and comply with the requirements of the protocol.
- 1. Has prior or current diagnosis of acute promyelocytic leukemia (APL) or MDS/AML (as defined in Döhner et al. 2022 Table 1).
- 7. Has any condition that, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study
- 8. Has received prior treatment with L-asparaginase
- 11. Has received a total cumulative prior anthracycline dose of > 300 mg/m2 (daunorubicin equivalent dose).
- 9. Pregnant or breastfeeding
- 12. Has relapsed or refractory AML with a FLT3 mutation, unless resides in a country where gilteritinib is not available
- 10. Known hypersensitivity to anthracyclines, cytarabine, the excipients of L-Annamycin for Injection or Cytarabine Injection, or contrast media that may be used for the protocol specified GLS assessments
- 2. Received prior mediastinal radiotherapy
- 3. Has central nervous system involvement
- 4. Has impaired cardiac function, as per protocol
- 5. Has clinically relevant serious comorbid medical conditions including, but not limited to, active infection, chronic obstructive or chronic restrictive pulmonary disease, history of positive status for human immunodeficiency virus (virus detected in serum), hepatitis B, or hepatitis C with current serious symptoms or signs of underlying chronic infection, or psychiatric illness/social situations that would limit compliance with study requirements
- 6. Has evidence of mucositis/stomatitis at screening or baseline, or has history of severe (≥Grade 3) mucositis/stomatitis from prior therapy
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- South Africa
- United States
- Georgia
- Egypt
- Jordan
- Saudi Arabia
- Australia
- United Arab Emirates
- United Kingdom
- Korea, Republic of
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.
Where is this trial taking place?
Study sites include Ukraine; South Africa; United States; Georgia; Egypt; Jordan and 5 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.