Clinical trial NCT06855810: Newly-diagnosed Pediatric T-cell ALL Protocol
Official title: Chinese Children's Cancer Group T-cell Acute Lymphoblastic Leukemia -2025 Project
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Lymphoblastic Leukemia
Childhood Leukemia, Acute Lymphoblastic
T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
Keywords: dasatinib
venetoclax
homoharringtonine
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 610
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter study conducted within the Chinese Children's Cancer Group (CCCG). The study aims to evaluate whether the addition of three novel agents, dasatinib, venetoclax and homoharringtonine, can improve the minimal residual disease (MRD)-negative remission rate, enhance event-free survival (EFS), and reduce the cumulative incidence of relapse (CIR) in pediatric patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL).

Detailed description: The CCCG-T-ALL-2025 protocol will be modified as following based on the above analysis of the CCCG-ALL-2020 protocol.

1. All T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy.
2. All non-ETP T-ALL patients will receive dasatinib after initial window phase in induction therapy.
3. non-ETP T-ALL patients with MRD ≥ 0.01% on day 46 will be stratified and randomized to receive different doses of homoharringtonine during early intensification.
4. For all ETP/near-ETP T-ALL patients, venetoclax will replace daunorubicin in induction therapy.
5. For all ETP/near-ETP T-ALL patients, venetoclax will replace daunorubicin in interim therapy 2 and 4.
6. CAT will replace CAT+ during early intensification, and will be administrated to all ETP/near-ETP patients, as well as non-ETP patients with MRD\< 0.01% on day 46.

2.11.7 In maintenance therapy 2, the CTX+Ara-C treatment cycles are reduced to 5, in order to minimize the impact of alkylating agents on fertility.

2.11.8 Add drug sensitivity testing for T-ALL.

Eligibility criteria: Inclusion Criteria:

1. Age older than 1 month to younger than 18 years.
2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
3. Diagnosis of T-ALL by immunophenotyping.

Exclusion Criteria:

1. B-ALL
2. AML
3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
4. ALL evolved from chronic myeloid leukemia (CML).
5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
6. Secondary leukemia
7. Known underlying congenital immunodeficiency or metabolic disease
8. Congenital heart disease with cardiac insufficiency.
9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)
10. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.
11. Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.

Primary outcomes:
measure: End-of-induction(EOI) measurable residual diseases (MRD)-negativity rate in patients with non-ETP T-ALL treated with dasatinib plus 4-drug induction compared to those treated with 4-drug induction in CCCG-ALL-2020
timeFrame: The expected study duration is approximately 5 years.
measure: For non-ETP T-ALL patients with positive measurable residual diseases (MRD) on day 46, to compare MRD-negativity rate before consolidation between those receiving single agent homoharringtonine at dose of 1mg/m2 vs. 2mg/m2 for 7 days
timeFrame: The expected study duration is approximately 5 years.
measure: End of induction (EOI) measurable residual diseases (MRD)-negativity rate with venetoclax plus 3-drug induction, compared to those treated with 4-drug induction on CCCG-ALL-2020 in treating ETP/near-ETP T-ALL.
timeFrame: The expected study duration is approximately 5 years.
measure: In interim therapies 2 and 4, venetoclax replaced daunorubicin to evaluate whether this change could improve event-free survival compared to similar patients on CCCG-ALL-2020 in treating ETP/near-ETP T-ALL.
timeFrame: The expected study duration is approximately 5 years.
Secondary outcomes:
measure: Event-free survival (EFS) of patients treated with this therapy, in comparison to historical regimens.
timeFrame: Approximately 6.5 years.
measure: Overall survival (OS) of patients treated with this therapy, in comparison to historical regimens
timeFrame: Approximately 6.5 years.
measure: Cumulative incidence of relapse (CIR) of this therapy, in comparison to historical regimens.
timeFrame: Approximately 6.5 years.
measure: Incidence of Grade 4 Treatment-Emergent Adverse Events (TEAE) associated with venetoclax and homoharringtonine
timeFrame: Up to 30 days after last dose of study treatment
Other outcomes:
measure: To explore the pharmacokinetic profiles of bioavailability for homoharringtonine and venetoclax with Peak Plasma Concentration (Cmax)
timeFrame: Up to 30 days after last dose of study drug administration
measure: To explore the pharmacokinetic profiles of bioavailability for homoharringtonine and venetoclax with Area Under the Plasma Concentration-Time Curve (AUC)
timeFrame: Up to 30 days after last dose of study drug administration
measure: To explore the pharmacokinetic profiles of absorbance duration for homoharringtonine and venetoclax with Time to Peak Concentration (Tmax)
timeFrame: Up to 30 days after last dose of study drug administration
measure: To explore the pharmacokinetic profiles of absorbance duration for homoharringtonine and venetoclax with Clearance (Cl)
timeFrame: Up to 30 days after last dose of study drug administration
measure: To explore the pharmacodynamic profiles of homoharringtonine and venetoclax.
timeFrame: Up to 30 days after last dose of study drug administration
Locations:
city: Hefei
country: China
facility: Anhui Medical University Second Affiliated Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Children's Hospital
state: Anhui
city: Chongqing
country: China
facility: Chongqing Medical University Affiliated Children's Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Children's Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjin
country: China
facility: Nanjing Children's Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Children's Hospital
state: Jiangxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Northwest Women and Children Hospital
state: Shanxi
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Shenzhen
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
state: Tianjin
city: Hong Kong
country: Hong Kong
facility: Hong Kong Children's Hospital
Study officials:
affiliation: Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
name: Xiaofan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
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