Newly-diagnosed Pediatric T-cell ALL Protocol
CCCG-TALL-2025
Chinese Children's Cancer Group T-cell Acute Lymphoblastic Leukemia -2025 Project
1 other identifier
interventional
610
2 countries
27
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2025
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 4, 2025
CompletedStudy Start
First participant enrolled
March 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
August 26, 2025
August 1, 2025
5.2 years
February 4, 2025
August 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
For this objective a one-sided comparison of probabilities (proportions) will be made. Let p1 and p2 be the probability of aciieving negative EOI MRD on the CCCG-ALL-2020 (historical control) and the current study respectively, then the one-sided alternative hypothesis H0: p2=p1 vs. H1: p2\>p1 will be tested. The procedure of two-sample comparison of proportions with the Z-statistic (Normal approximation) will be applied. The current CCCG-ALL2020 data show that among 573 evaluable patients 510 (89%) achaived negative EOI MRD. Benchmarking on these as historical data, a total sample size of n=550 and interim sample size n1=300 provides sufficient popwer for the planned analyses outlined above if the true MRD negativity probability is 0.92 or higher, as shown in the table below. An interim analysis at n1=300 evaluable patients will be conducted for possible abstract submission or publication.
The expected study duration is approximately 5 years.
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
The comparison will be condicted by testing the two-sided hypothesis H0: p1=p2 vs. H1: p1≠p2, using the Z test (normal approximation) at alpha=0.10 level. The investigators anticipate approximately 40 patients available to be randomized. The participants will be randomized at 1:1 ratio into the two treatment arms, with 20 patients per arm. Stratified block-wise randomization will be applied with block size of 4. The randomization will be stratified by the EOI MRD level as \<1% and \>=1%.
The expected study duration is approximately 5 years.
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.
The investigators anticipate at least 60 evaluable ETP participants. The analysis will be conducted by testing H0: p2=p1 vs. H1: p2\>p1, where p1, p2 are MRD-negative probabilities in the CCCG-ALL-2020 and the current study respectively. The Z-statistic (normal approximation) based procedure will be applied.
The expected study duration is approximately 5 years.
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.
The investigators anticipate at least 60 evaluable participants. The event-free survival function will be estimated by the Kaplan-Meier method. Comparison will be conducted using the two-sided log-rank test.
The expected study duration is approximately 5 years.
Secondary Outcomes (4)
Event-free survival (EFS) of patients treated with this therapy, in comparison to historical regimens.
Approximately 6.5 years.
Overall survival (OS) of patients treated with this therapy, in comparison to historical regimens
Approximately 6.5 years.
Cumulative incidence of relapse (CIR) of this therapy, in comparison to historical regimens.
Approximately 6.5 years.
Incidence of Grade 4 Treatment-Emergent Adverse Events (TEAE) associated with venetoclax and homoharringtonine
Up to 30 days after last dose of study treatment
Other Outcomes (5)
To explore the pharmacokinetic profiles of bioavailability for homoharringtonine and venetoclax with Peak Plasma Concentration (Cmax)
Up to 30 days after last dose of study drug administration
To explore the pharmacokinetic profiles of bioavailability for homoharringtonine and venetoclax with Area Under the Plasma Concentration-Time Curve (AUC)
Up to 30 days after last dose of study drug administration
To explore the pharmacokinetic profiles of absorbance duration for homoharringtonine and venetoclax with Time to Peak Concentration (Tmax)
Up to 30 days after last dose of study drug administration
- +2 more other outcomes
Study Arms (3)
(near)ETP-ALL
EXPERIMENTALAll T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy. For all ETP/near-ETP T-ALL patients, venetoclax will replace daunorubicin in induction therapy. CAT will replace CAT+ during early intensification. Venetoclax will replace daunorubicin in interim therapy 2 and 4. 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.
nonETP-TALL-Das Group
EXPERIMENTALAll T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy. All non-ETP T-ALL patients will receive dasatinib after initial window phase in induction therapy. For non-ETP T-ALL patients with MRD \<0.01% on day 46, CAT will replace CAT+ during early intensification, and patients will be continuously subjected to dasatinib combined with chemotherapy during early intensification, interim tharapy, reinduction therapy and maintenance therapy. 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.
nonETP-TALL-HHT Group
EXPERIMENTALAll T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy. All non-ETP T-ALL patients will receive dasatinib after initial window phase in induction therapy. For non-ETP T-ALL patients with MRD ≥0.01% on day 46，CAT+ will be replaced with randomized doses of homoharringtonine (HHT) during early intensification, and HHT will be administrated during reinduction therapy. 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.
Interventions
All T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy. For all ETP/near-ETP T-ALL patients, venetoclax will replace daunorubicin in induction therapy. CAT will replace CAT+ during early intensification. Venetoclax will replace daunorubicin in interim therapy 2 and 4. 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.
All T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy. All non-ETP T-ALL patients will receive dasatinib after initial window phase in induction therapy. For non-ETP T-ALL patients with MRD \<0.01% on day 46, CAT will replace CAT+ during early intensification, and patients will be continuously subjected to dasatinib combined with chemotherapy during early intensification, interim tharapy, reinduction therapy and maintenance therapy. 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.
All T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy. All non-ETP T-ALL patients will receive dasatinib after initial window phase in induction therapy. For non-ETP T-ALL patients with MRD ≥0.01% on day 46，CAT+ will be replaced with randomized doses of homoharringtonine (HHT) during early intensification, and HHT will be administrated during reinduction therapy. 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.
Eligibility Criteria
You may qualify if:
- Age older than 1 month to younger than 18 years.
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- Diagnosis of T-ALL by immunophenotyping.
You may not qualify if:
- B-ALL
- AML
- Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
- ALL evolved from chronic myeloid leukemia (CML).
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction
- Secondary leukemia
- Known underlying congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency.
- 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)
- Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Anhui Medical University Second Affiliated Hospital
Hefei, Anhui, China
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Chongqing Medical University Affiliated Children's Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan Children's Hospital
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
The Third Xiangya Hospital of the Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Nanjing Children's Hospital Affiliated to Nanjing Medical University
Nanjin, Jiangsu, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Xi'an Northwest Women and Children Hospital
Xi’an, Shanxi, China
Shenzhen Children's Hospital
Shenzhen, Shenzhen, China
West China Second University Hospital
Chengdu, Sichuan, China
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Tianjin, Tianjin Municipality, China
Hong Kong Children's Hospital
Hong Kong, Hong Kong, Hong Kong
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaofan Zhu, MD
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2025
First Posted
March 4, 2025
Study Start
March 11, 2025
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2031
Last Updated
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- IPD will be made available upon publication of the primary trial results or after trial completion, whichever occurs first, starting on 2032, and will remain accessible for 5 years.
- Access Criteria
- Researchers, healthcare professionals who meet the criteria for access (e.g., academic researchers conducting secondary analyses or regulatory bodies reviewing safety data) will be able to request access to de-identified IPD and supporting information. Access will be facilitated through clinical trials.gov/emailing to PI, where users can submit a request and provide a research proposal. Data access will be granted after a formal review and approval process, subject to compliance with the data-sharing agreement and confidentiality terms.
1. Demographic Data: Age, sex, and other relevant baseline characteristics. 2. Treatment Information: Data on interventions received by participants, including dosage, treatment cycles, and duration. 3. Outcome Measures: Detailed information on primary and secondary outcome measures, such as response rates, survival rates, adverse events, and any the pre-specified endpoints. 4. Adverse Events: Data on all reported adverse events, including severity, duration, and outcome. 5. Laboratory Data: Results from laboratory tests, such as blood counts, biochemical markers, or molecular analysis. 6. Medical History: Pre-existing conditions, comorbidities, and prior treatments or interventions. 7. Vital Signs: relevant physiological data. 8. Efficacy and Safety Data: Any data relating to the efficacy (e.g., event-free survival) and safety (e.g., adverse effects) of the treatment.