NCT05736978RecruitingPhase 2
Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results
Clinical Efficacy and Safety of Adaptive Treatment of Acute Myeloid Leukemia (AML) Based on D14 MRD results-a Multicenter, Single-arm, Prospective Clinical Study
Source: ClinicalTrials.gov · Last updated 15 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia based on MRD results on day 14 of the first cycle.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 12 Feb 2023
- Start date
- 31 Mar 2023
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Shanghai Tong Ren Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05736978
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 58
- From 31 Mar 2023 to the primary completion date, 1 Mar 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of any malignancies prior to study entry with exception noted in the protocol.
- Must not have received prior anti-AML treatment except for hydroxyurea
Other illness
- Participant has known HIV infection, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) .
Other
- Participant has known active central nervous system (CNS) involvement with AML.
Who the study is looking for
- Known and written informed consent voluntarily
- Age ≥ 18 years
- Newly diagnosed AML patients (per WHO 2022 classification criteria for AML diagnosis), who are not suitable for intensive chemotherapy:
- 75 years or Aged 18 to 74 years with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3 or 4; Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction \<= 50% or chronic stable angina; Diffusing capacity of the Lung for Carbon Monoxide (DLCO) \<= 65% or Forced Expiratory Volume in 1 second (FEV1) \<= 65%; Creatinine clearance \>= 30 mL/min to \< 45 ml/min; Moderate hepatic impairment with total bilirubin \> 1.5 to \<= 3.0 × Upper Limit of Normal (ULN); Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy .
- Liver function meets the following criteria: aspartate aminotransferase (AST) ≤ 3.0×ULN\*; alanine aminotransferase (ALT) ≤3.0×ULN\*; Bilirubin≤1.5×ULN\*; For subjects \<75 years old, the bilirubin level can be ≤3.0×ULN; Unless due to leukemic organ involvement.
- Renal function meets the following criteria: creatinine clearance ≥ 30 mL/min (Cockroft-Gault formula)
- Life expectancy ≥ 4 weeks
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tong Ren hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Pla Navy Feature Medical Center Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Beizhan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai Ruijin Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.