Trial Title:
AZD4205 in Peripheral T Cell Lymphoma Following First-Line Therapy (JACKPOT26)
NCT ID:
NCT06511869
Condition:
Peripheral T-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AZD4205
Description:
AZD4205 capsules administered at 150 mg orally, once daily, in 28-day cycle.
Arm group label:
AZD4205 treatment
Summary:
This study is intended to assess the safety and anti-tumor activity of AZD4205 at 150 mg
once daily in participants with PTCL who have achieved tumor response after first-line
systemic therapy (with or without combination radiotherapy) and are ineligible for HSCT
assessed by the investigator as ineligible for HSCT or have no plan for HSCT.
Criteria for eligibility:
Criteria:
Inclusion criteria
1. ≥ 18 years old.
2. ECOG status score ranging from 0 to 1, without any deterioration in the past two
weeks.
3. Life expectancy ≥ 3 months.
4. Have histopathologically confirmed PTCL that meets the pathological subtypes (except
for ALCL-ALK+) as specified in the latest WHO classification of lymphoid neoplasms
in 2016.
5. Must be assessed to achieve complete or partial response according to Lugano's
criteria after first-line systemic standard of therapy:
- The participants should be assessed as ineligible for HSCT
- For participants with CR, the end of initial treatment should be ≤ 3 months
from the planned first dose in this study.
6. Adequate bone marrow hematopoietic function and organ function reserve.
7. LVEF ≥ 50% by ECHO.
8. Should be able to follow the relevant requirements of this study for medication and
follow-up.
9. If there is a potential for conception for the female spouses (partners) of male
participants, the spouses (partners) should take physical contraceptive measures
(such as condoms) during the participant participating in the trial and within 6
months after the end of treatment.
10. Male participants should also avoid sperm donation during the trial and within 6
months after the end of treatment.
11. Female participants should take adequate contraceptive measures and vasoligation of
the partner during the trial and within 3 months after the end of the trial. All
hormonal contraceptive methods (except abstinence) should be used in conjunction
with the use of a condom by the male partner. Breastfeeding is prohibited for female
participants. Female participants of conception potential should have a negative
pregnancy test prior to initiation of treatment.
Exclusion criteria
1. With any of the following treatment history:
- The use of the investigational product or investigational product in another
project within 30 days prior to the start of dosing in this study.
- The cytotoxic chemotherapeutic agents are not discontinued within 21 days prior
to the start of dosing in this study.
- Prior use of histone deacetylase (HDAC) inhibitors (e.g., romidepsin,
chidamide, belinostat) or pralatrexate within 1 week prior to the start of
dosing in this study.
- Prior use of corticosteroid therapy at equivalent prednisone dose > 15 mg/day
within 1 week prior to the start of dosing in this study.
- Undergoing major surgery (excluding vascular access surgery) or serious trauma
within 4 weeks prior to the start of dosing in this study; or anticipated to
undergo potential surgery after the start of dosing in this study.
- Prior use of anti-tumor macromolecular antibody agents (including brentuximab
vedotin) within 4 weeks; radiation therapy within 3 weeks; and other
toxin/isotope-immune antibody couplers within 10 weeks prior to the start of
dosing in this study.
- With prior use of JAK or STAT3 inhibitors.
- Prior use of anti-tumor immunotherapy (e.g., immune checkpoint inhibitors,
including PD-1, PD-L1, and CTLA-4) within 28 days prior to the start of dosing
in this study. For participants treated with other types of novel therapy,
whether they can be included may be jointly decided by the investigator and the
sponsor's study physician.
- Vaccination with attenuated vaccines or viral vector vaccines within 28 days
prior to the start of dosing in this study.
- Currently on treatment with vitamin K antagonists, antiplatelets, and
anticoagulants (or these drugs cannot be discontinued within 1 week prior to
the start of dosing in this study).
- Currently on treatment with (or unable to discontinue the use within 1 week
prior to the start of dosing in this study) certain known drugs, herbs, or
supplements that may significantly induce or inhibit CYP3A or can serve as
sensitive substrates of BCRP/P-gp, with low therapeutic indexes.
2. With unresolved > CTCAE Grade 1 adverse drug reactions (except alopecia) prior to
the start of dosing in this study.
3. Central nervous system or meninges involvement by the lymphoma.
4. With significant lung function impairment (i.e., pulmonary function tests show FEV1
and DLCO < 60% of predicted values). Participants with prior history of
non-infectious pneumonitis, drug-induced interstitial lung disease, radiation
pneumonitis requiring steroid therapy, or evidence showing clinically active
interstitial lung disease.
5. With diseases or conditions requiring treatment with immunosuppressive agents,
similar biological agents, or non-steroidal analgesic-antipyretic drugs.
6. Active infection, including:
- Known active/latent tuberculosis (screening should be performed according to
the routine procedures of local clinical sites, such as PPD test, T-SPOT, and
X-ray/CT).
- With positive HIV test or serological hepatitis markers.
- Active viral infections (e.g., herpes zoster) other than hepatitis B or
hepatitis C.
- Infections requiring oral or intravenous antimicrobial therapy.
- Bacterial infection within 30 days, including pneumonia.
7. Any of the following cardiac abnormalities:
- With congestive heart failure (CHF) > NYHA Class II.
- With significant clinical manifestations of valvular disease and
hypertrophic/constrictive cardiomyopathy.
- With serious cardiac rhythm, conduction, morphological abnormalities on any
resting ECG, such as complete left bundle branch block, 2/3-degree
atrioventricular block, and PR interval > 250 ms.
- Ventricular arrhythmia requiring treatment.
- Acute myocardial infarction (AMI) within 6 months prior to the start of
treatment in the trial; unstable angina pectoris or new angina pectoris.
- Who have undergone heart transplantation.
- Corrected QTcF interval (QTc) > 450 ms on resting ECG at screening.
- With increased risks of QT prolongation or arrhythmia (e.g., heart failure,
hypokalemia, congenital long QT syndrome, or taking other drugs causing QT
prolongation; or with a family history of long QT syndrome; or those with
first-degree relatives showing unexpected sudden death under 40 years of age.
- Prior or current history of thrombotic diseases such as pulmonary embolism and
deep vein thrombosis.
8. Prior history of malignancies (except completely eradicated cervical, uterine, basal
cell, or squamous cell carcinoma in situ, or non-melanoma skin carcinoma in situ)
within 5 years prior to enrollment.
9. With symptoms of intractable nausea or vomiting that cannot be well controlled with
supportive treatment, chronic gastrointestinal disease, capsule dysphagia, or prior
surgical removal of bowel segments that may compromise adequate absorption of the
drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
Address:
City:
Hefei
Country:
China
Facility:
Name:
Peking university Third Hospital
Address:
City:
Beijing
Country:
China
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
The Fifth Affiliated Hospital of Sun Yat-sen University
Address:
City:
Zhuhai
Country:
China
Facility:
Name:
Hainan General Hospital
Address:
City:
Haikou
Country:
China
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Thechnology
Address:
City:
Wuhan
Country:
China
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Facility:
Name:
Reasearch Center of Clinical Trials, The Third Xiangya Hospital of Central South University
Address:
City:
Changsha
Country:
China
Facility:
Name:
The Affiliated Hospital of Inner Mongolia Medical University
Address:
City:
Hohhot
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Facility:
Name:
Shandong Cancer Hospital & Insititution
Address:
City:
Jinan
Country:
China
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Country:
China
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Country:
China
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Country:
China
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Country:
China
Facility:
Name:
The First Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Start date:
March 17, 2022
Completion date:
March 2026
Lead sponsor:
Agency:
Dizal Pharmaceuticals
Agency class:
Industry
Source:
Dizal Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511869
