CVA Regimen Bridging to HSCT for R/R AL

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    48
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 3 May 2022

Summary

Although allogeneic hematopoietic stem cell transplantation (HSCT) is a curative treatment option for acute leukemia (AL), relapsed or refractory (R/R) AL is still a big challenge. It is believed that decreased tumor burden before HSCT is a favorable factor contributing to the long-term survival of R/R AL patients and many kinds of bridging chemotherapy regimens were devised to kill leukemic cells before HSCT, there is still no consensus that which regimen is optimal. This study is to investigate the curative efficacy and safety of bridging CVA (cladribine combined with venetoclax and low dose Ara-C) regimens followed by HSCT treatment protocol for R/R AML.

Details
Condition Acute Leukemia, Relapsed, Acute Leukemia Refractory
Treatment CVA regimen bridging to HSCT
Clinical Study IdentifierNCT05190549
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on3 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with AL must meet one of the following criteria :A or B. A: relapsed AL disease was defined as follows: (1) Reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of >5% blasts in the bone marrow (BM) not attributable to another cause(e.g. regeneration after consolidation therapy); or (3) extramedullary relapse
refractory AL disease was defined as follows: (1): failure to attained CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI)<50% and >15% blast existence after one course of standard or intensive induction therapy
patients without serious disease of heart or liver or lung or kidneys
sign informed consent voluntarily
Patients aged between 18 and 65 years old, male or female is permitted
ECOG performance status score less than 1
The expected survival is longer than 3 months

Exclusion Criteria

With other malignant tumors
Patients received the treatment of cladribine or venetoclax
Patients received cardiac angioplasty or stent implantation
Active infections that are not under clinical control (bacteria or fungus or virus is included)
Liver functions abnormalities (total bilirubin>1.5 times the upper limit of the normal range, ALT/AST>2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST>1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine>1.5 times the upper limit of normal value)
Pregnant or nursing women
Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met
Patients participated in any other clinical trials 3 months prior to signing the informed consent
Patients not suitable for the study according to the investigator's assessment
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note