NCT05870995RecruitingPhase 2
Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
A Phase II Single Arm Study of Cladribine, Cytarabine, Etoposide and Venetoclax Sequential With Reduced Dose Conditioning of Fludarabine, Busulfan and Melphalan or Total Marrow Radiation for Refractory Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 18 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The investigators developed a protocol combining chemotherapy of cladribine, cytarabine and etoposide (CLAGE) as debulking treatment sequential with reduced intensity conditioning regimen Flu-Bu to treat patients with refractory acute myeloid leukemia (AML). In this study, the aim is to further evaluate the efficacy and feasibility of the protocol with modifications: 1) reduced dose of CLAGE; 2) Reduced intensity conditioning (RIC) regimen as fludarabine, busulfan and melphalan (MBF) or total marrow irradiation (TMI); 3) Venetoclax was added to the chemotherapy and conditioning regimen.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 13 May 2023
- Start date
- 1 Feb 2023
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT05870995
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 1 Feb 2023 to the primary completion date, 1 Feb 2026
- 3 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.
Other illness
- patients with poor cardiac function （EF\<45%）
Lab values
- patients with abnormal liver function (enzyme \>2N or bilirubin \>2N)
Other
- patients with abnormal renal function (Scr \>1.5N)
Who the study is looking for
- patients with refractory AML: no remission after 2 induction therapy, relapsed AML within 6 months of 1st CR, relapse AML fail to having CR after reinduction therapy, multiple relapse and refractory relapse AML
- patients with \>5% bone marrow blast by morphology or by LAIP flowcytometry at enrollment
- patients with HLA-matched sibling donor, 9-10/10 matched unrelated donor or haplo-identical family donor
- patients without active infection
- informed consent provided
Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blood & Marrow Transplantation Center, RuiJin Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai ZhaXin Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Department of Hematology, Shanghai No 6 Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.