Clinical trial for Relapsed or Refractory Acute Myeloid Leukemia
Official title Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT05726110
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, being studied as a potential treatment for relapsed or refractory acute myeloid leukemia.
Also referred to as KPT-330.
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 clinical trial studies the efficacy and safety of selinexor combined with HAD or CAG regimen in the treatment of relapsed or refractory acute myeloid leukemia
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Age:18-60 years old;
- Except for patients with AML-M3 with acute myeloid leukemia；
- Meet the diagnostic criteria for refractory AML (2011 Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (relapsed or...
- Meet the diagnostic criteria for recurrent AML (refer to the 2014 NCCN guidelines): after complete remission, (1) naive cells appear in peripheral...
- The bone marrow image indicates active hyperplasia or hypoproliferation；
You likely can't join if
- Accompanied by cerebral hemorrhage；
- Pregnancy；
- Have a mental illness or other condition that cannot proceed as planned；
- Severe arrhythmia, abnormal ECG (QT\>500ms). Early withdrawal from test criteria： Participants have the right to withdraw from the study at any time...
- The subject or the subject's legally authorized representative requests to withdraw from the study;
- Participant loss to follow-up. Doctor/Investigator required people to terminate the trial early:
See the full eligibility criteria
- Age:18-60 years old;
- Except for patients with AML-M3 with acute myeloid leukemia；
- Meet the diagnostic criteria for refractory AML (2011 Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (relapsed or refractory)):(1) The standard regimen did not achieve complete remission...
- Meet the diagnostic criteria for recurrent AML (refer to the 2014 NCCN guidelines): after complete remission, (1) naive cells appear in peripheral blood; (2) \>5% of bone marrow naive cells; (3) Extramedullary...
- The bone marrow image indicates active hyperplasia or hypoproliferation；
- Eastern Oncology Collaborative Group Physical Status Assessment (ECOG-PS) with a score of 0-2.
- Accompanied by cerebral hemorrhage；
- Pregnancy；
- Have a mental illness or other condition that cannot proceed as planned；
- Severe arrhythmia, abnormal ECG (QT\>500ms). Early withdrawal from test criteria： Participants have the right to withdraw from the study at any time from the trial. Exit Criteria:
- The subject or the subject's legally authorized representative requests to withdraw from the study;
- Participant loss to follow-up. Doctor/Investigator required people to terminate the trial early:
- people who are unable to carry out follow-up treatment due to adverse events (serious irreversible organ function damage during treatment) who are judged by the investigator to be unsuitable for continuing the research;
- The subject does not adhere to the protocol, such as the use of chemotherapy drugs, etc., which affects the how well it works and safety judgment. For participants who withdrew early from the study (except people who...
The study team makes the final eligibility decision.
Where it's taking place
- Taiyuan, Shanxi, 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, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiyuan, Shanxi, 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.