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Taking people in ChinaPhase 2

Chemotherapy and conditioning treatment for refractory acute myeloid leukemia

Tests a chemotherapy plan with venetoclax before transplant in people with refractory acute myeloid leukemia.

Plain-language title generated from the registry record
Registry title: Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia

Key facts

Where
Shanghai, ChinaSee the 3 sites
Phase
Phase 2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 16 to 65 with acute myeloid leukemia (AML) that did not respond to treatment or came back, and who have a stem-cell donor available.

Age
16 to 65 years
Sex
All sexes
Disease stage
Refractory AML: no remission after 2 induction treatments, relapse within 6 months of first complete remission, no remission after re-treatment, or multiple relapses. More than 5% blast cells in the bone marrow at enrollment.
Earlier treatment
No remission after 2 induction treatments, or relapse after earlier treatment, as described under disease stage.
Biomarker or test result
Bone marrow blast cells above 5% by microscope or by LAIP flow cytometry. A donor is needed: HLA-matched sibling, 9-10/10 matched unrelated donor, or haplo-identical family donor.

Main reasons for not taking part

  • Abnormal liver function (enzymes or bilirubin above 2 times normal)
  • Abnormal kidney function (creatinine above 1.5 times normal)
  • Poor heart function (EF below 45%)
  • Active infection

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 16 and 65 years old?

Source: NCT05870995, who can take part

Where in China

  • Blood & Marrow Transplantation Center, RuiJin HospitalShanghai, ChinaContact: Jiong HU, M.D.,Taking people
  • Department of Hematology, Shanghai No 6 HospitalShanghai, ChinaContact: Chunkang ChangTaking people
  • Shanghai ZhaXin HospitalShanghai, ChinaContact: Chun WangTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Shanghai Jiao Tong University School of Medicine
Trial code
NCT05870995
Record updated
18 February 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: patients with poor cardiac function （EF<45%）; patients with abnormal liver function (enzyme >2N or bilirubin >2N); patients with abnormal renal function (Scr >1.5N).

ClinicalTrials.gov NCT05870995