NCT06643195Not yet recruiting
Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients With High-Risk Acute Myeloid Leukemia
Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients With High-Risk Acute Myeloid Leukemia: a Randomised, Open-label, Phase 2 Clinical Trial.
Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to investigate whether immediate HSCT for patients with high-risk AML and intermediate-risk AML who have not achieved complete remission (CR) after their first induction therapy is non-inferior to re-treatment with chemotherapy.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 358 (estimated)
- First submitted
- 22 Sept 2024
- Start date
- Jan 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06643195
What you commit to
- Study type: Interventional
- Planned participants: 358
- From Jan 2025 to the primary completion date, Sept 2027
- 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
- Patient has received more than 440 mg/m2 daunorubicin equivalents. The cumulative dose is calculated by summing up isotoxic daunorubicin-equivalents for daunorubicin, doxorubicin, epirubicin, idarubicin and mitoxantrone. The conversion factors are derived from the comparison of the respective maximum doses. The conversion factor is 1 for daunorubicin, 1 for doxorubicin, 0.6 for epirubicin, 4.6 for idarubicin, and 2.7 for mitoxantrone (see worksheet for calculation).
Lab values
- Severe organ dysfunction, defined as:
- 1\) Left ventricular ejection fraction \<50%. 2) Patients who receive supplementary continuous oxygen. 3) Serum bilirubin \>1.5 x ULN (if not considered Gilbert-Syndrome) or ASAT/ALAT \>5 x ULN.
- 4\) Estimated Glomerular Filtration Rate (GFR) \< 50 ml/min, where: Estimated GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black) 4. History of allogeneic transplantation. 5. Manifestation of AML in the Central Nervous System. 6. Pregnant or breastfeeding women.
Other
- Acute promyelocytic leukemia.
Who the study is looking for
- AML patients aged ≥ 18 years.
- High-risk AML patients according to the 2022 ELN standards who received one cycle of induction therapy.
- Requires allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic HSCT and unrelated donor transplant).
- KPS score greater than 60.
- Informed consent must be signed before the start of the study procedures; if it is detrimental to the patient's condition for them to sign, the consent may be signed by a legal guardian or immediate family member.
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 |
|---|---|---|---|
| People's Liberation Army The General Hospital of Western Theater Command Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Hebei Medical University Second Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Zhengzhou University - First Affiliated Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.