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New treatment option for Myeloid Leukemia
Official title Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
ClinicalTrials.gov ID: NCT06130579
What this study is testing
What is IFN-Α?
IFN-Α is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myeloid leukemia.
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
- To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML/MDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- 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 12 to 65
You may be able to join if
- Myelodysplastic syndrome (MDS) diagnosed according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemia...
- Male or female, aged 12-65 years
- Karnofsky score \>60, estimated survival time \>3 months
- No history of severe graft-versus-host disease (GVHD), uncontrolled GVHD, or severe systemic organ dysfunction:
- Absolute neutrophil count (ANC) greater than 0.5×109/L
You likely can't join if
- severe cardiac, renal, or liver dysfunction
- combined with other malignant tumors requiring treatment
- inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness
- patients who are unable to complete the necessary treatment plan and follow-up observation
- patients with severe acute anaphylaxis
- clinically uncontrolled severe life-threatening infections
See the full eligibility criteria
- Myelodysplastic syndrome (MDS) diagnosed according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemia (2022ICC) criteria, acute myeloid leukemia (AML) with TP53 mutation...
- Male or female, aged 12-65 years
- Karnofsky score \>60, estimated survival time \>3 months
- No history of severe graft-versus-host disease (GVHD), uncontrolled GVHD, or severe systemic organ dysfunction:
- Absolute neutrophil count (ANC) greater than 0.5×109/L
- Creatinine \< 1.5mg/dL
- Cardiac ejection index \>55%
- Signed informed consent.
- severe cardiac, renal, or liver dysfunction
- combined with other malignant tumors requiring treatment
- inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness
- patients who are unable to complete the necessary treatment plan and follow-up observation
- patients with severe acute anaphylaxis
- clinically uncontrolled severe life-threatening infections
- patients enrolled in other clinical trials
- other reasons considered by the investigator to be inappropriate for clinical trial participants.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.