NCT05870995

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
4mo left

Started Feb 2023

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2023Sep 2026

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

May 13, 2023

Last Update Submit

February 14, 2025

Conditions

Refractory Leukemia

Keywords

refractory AML, allogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • disease-free survival (DFS)

    patients remain alive in remission without disease progression or relapse

    2 year

Secondary Outcomes (6)

  • complete remission (CR)

    day 60

  • Overall survival (OS)

    2 year

  • non-relapse mortality (NRM)

    day 100

  • non-relapse mortality

    2 year

  • relapse

    2 year

  • +1 more secondary outcomes

Study Arms (1)

CLAGE-VEN-RIC-Conditioning

EXPERIMENTAL

Cladribine: 5mg/m2 day -21 to d -17 cytarabine: 1g/m2 day -21- to d -17 etoposide: 100mg/m2 day -17 to -15 venetoclax: 100mg day-21; 200mg day -20, 400mg day -19 to day-3 Fludarabine: 30mg/m2 day -7 to -3 Busulfan: 3.2mg/kg day -6 to -5 Melphalan: 50mg/m2 day -4 to -3. or Fludarabine 30mg/m2 day -7 to -3 Total marrow irradiation day-5 to -3 PBSC: day 0 Conditioning regimen cane delayed to in patients with ongoing active infection or work-up of donors after CLAGE-VEN chemotherapy based on clinicians' decision. Patients receiving all-HSCT in cytopenia are classified as sequential while patients with recovered CBC are considered as bridging transplantation.

Drug: CALGE-VEN- RIC-conditioning

Interventions

CALGE-VEN- RIC-conditioningDRUG

Intensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation

CLAGE-VEN-RIC-Conditioning

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with abnormal liver function (enzyme \>2N or bilirubin \>2N)
  • patients with abnormal renal function (Scr \>1.5N)
  • patients with poor cardiac function （EF\<45%）

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Department of Hematology, Shanghai No 6 Hospital

Shanghai, China

RECRUITING

Shanghai ZhaXin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Study Officials

  • Chun Wang

    Shanghai Zhaxin Integrated Traditional Chinese and Western Medicine Hospital

    STUDY DIRECTOR

Central Study Contacts

Jiong HU

CONTACT

86-21-64370045hj10709@rjh.com.cn

Jieling Jiang

CONTACT

+8613311986505jiangjieling66@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Blood & Marrow Transplantation Center, Rui Jin Hospital

Study Record Dates

First Submitted

May 13, 2023

First Posted

May 23, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

IPD data is available only based on request to PI and study director

Locations

CN(3)