To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluate the Efficacy and Safety of Interferon-α Combined With ATO in the Treatment of Arsenic-resistant APL
NCT ID:
NCT06450145
Condition:
Tumour
Conditions: Official terms:
Interferons
Venetoclax
Arsenic Trioxide
Conditions: Keywords:
APL
arsenic-resistant relapse
interferon α-2b
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
interferon α-2b
Description:
Eligible APL patients with arsenic-resistant relapse will enter the run-in period, and
the subjects in the run-in phase will be treated with arsenic combined with venetoclax.
After the run-in period, the patients were treated with interferon α-2b, arsenic trioxide
for injection and venetoclax until the outcome of CR/PR/PD/ death/withdrawal/loss to
follow-up occurred. Tumor assessments were performed every 4 to 6 weeks (as determined by
the investigator) during trial treatment. Those who achieved CR/PR/PD/ withdrawal were
then returned to standard treatment (treatment regimen was determined by the clinician),
and those who completed the combination treatment period of the trial entered the
survival follow-up period.
Arm group label:
interferon α-2b
Other name:
arsenic trioxide
Other name:
venetoclax
Summary:
This study was a single-arm, open study. After the screening period, arsenic-resistant
APL patients were treated with interferon α-2b, arsenic and venetoclax. The efficacy
(ORR) and safety were evaluated.
Detailed description:
Eligible APL patients with arsenic-resistant relapse will enter the run-in period, and
the subjects in the run-in phase will be treated with arsenic combined with venetoclax.
After the run-in period, the patients were treated with interferon α-2b, arsenic trioxide
for injection and venetoclax until the outcome of CR/PR/PD/ death/withdrawal/loss to
follow-up occurred. Tumor assessments were performed every 4 to 6 weeks (as determined by
the investigator) during trial treatment. Those who achieved CR/PR/PD/ withdrawal were
then returned to standard treatment (treatment regimen was determined by the clinician),
and those who completed the combination treatment period of the trial entered the
survival follow-up period.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Must sign an informed consent form (ICF) indicating that he or she understands
the purpose of, and procedures required for, the study and is willing to
participate in the study.
-
2. Age 18-70 years old (including boundary value);
-
3. The presence of promyelocytic leukemia-retinoic acid receptor alpha (PML-RARα)
confirmed by morphological features, cytogenetic analysis, and real-time
quantitative polymerase chain reaction (qPCR);
-
4. Arsenic relapse resistant patients: patients who had relapsed (including
molecular relapse) after remission with ATO in the previous treatment, and
could not be relieved after standard treatment;
-
5. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;
-
6. The expected survival time is more than 3 months.
Exclusion Criteria:
-
1. Allergy or contraindication to any study drug involved in the protocol;
-
2. Physical examination, electrocardiogram, laboratory examination, vital signs
and test related abnormalities are clinically significant (subject to
clinician's judgment);
-
3. Other serious conditions that may limit the patient's participation in the
trial, such as severe liver or kidney disease; "Patients with advanced
infection, uncontrolled diabetes mellitus, severe cardiac dysfunction (e.g.,
clinically significant prolongation of the QT interval, potentially fatal
torsades de pointes) or a history of angina or major heart disease, autoimmune
diseases (as judged by the clinician);"
-
4. Pregnant or lactating women;
-
5. Epilepsy and central nervous system dysfunction;
-
6. Active hepatitis B, active hepatitis A, HIV positive;
-
7. Participate in other clinical trials at the same time
-
8. Any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the participant (eg, compromise the
well-being) or that could prevent, limit, or confound the protocol-specified
assessments.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Zhejiang University
Address:
City:
Hangzhou
Zip:
310014
Country:
China
Status:
Recruiting
Contact:
Last name:
Yingjun Lou, doctor
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Zip:
310014
Country:
China
Status:
Recruiting
Contact:
Last name:
Rui Hao
Start date:
May 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Zhejiang Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Zhejiang University
Agency class:
Other
Source:
Zhejiang Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06450145
