Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)Phase 3CAMS-Ph+ B-ALLNCT07152041
Newly-diagnosed Pediatric Ph-positive B-ALL Protocol
A Phase 3 study testing olverembatinib in people with Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+) and Childhood Leukemia, Acute Lymphoblastic, run by Institute of Hematology & Blood Diseases Hospital, China at 24 sites in 2 countries.
Trial summary
This prospective clinical trial evaluates the effectiveness and safety of "chemotherapy-light" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric/adolescent patients with Ph+… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+), Childhood Leukemia, Acute Lymphoblastic
- What is being tested?
- olverembatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 28 Mar 2025to Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must meet all items below:
- Age older than 1 month to younger 18 years.
- Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
- Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
Who cannot join
- Should be excluded if had any item below:
- ALL evolved from CML.
- Known underlying congenital immunodeficiency or metabolic disease.
- Congenital heart disease with cardiac insufficiency.
- Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug.
- Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases.
Show all 9Show fewer
- Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS).
- Treated with glucocorticoids for ≥14 days, or targeted inhibitor for > 7 days within one month before enrollment, or any chemotherapy or any systemic anticancer therapy (including but not limited to any TKI) or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression).
- 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.
Trial locations and contacts
24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 2 countries
China23 sites, 23 recruiting
- Not yet recruiting
Hunan Children's Hospital
Changsha, Hunan
Wenyong Kuang, MD, 0731-85356114, kathy5460@sina.com
- Not yet recruiting
The Third Xiangya Hospital of the Central South University
Changsha, Hunan
Minghua Yang, MD, 0731-88618576, yangminghua@csu.edu.cn
- Not yet recruiting
West China Second University Hospita
Chengdu, Sichuan
Ju Gao, MD, 028-88570307, gaoju651220@126.com
- Not yet recruiting
Chongqing Medical University Affiliated Children's Hospital
Chongqing, Chongqing Municipality
Jie Yu, MD, 023-63632756, 1808106657@qq.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Jian Li, MD, 0591-83357896, 1354113723@qq.com
- Not yet recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong
Hua Jiang, MD, 020-81886332, jiang_hua18@sina.cn
- Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Xuedong Wu, MD, 020-61641114, xuedongwu@163.com
- Not yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Xuequn Luo, MD, 020-87755766, l-xuequn@126.com
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Jiao Jin, MD, 0851-86772025, jinjiao999@gmc.edu.cn
- Not yet recruiting
Anhui Medical University Second Affiliated Hospita
Hefei, Anhui
Ningling Wang, MD, 0551-63869302, zwnltt@126.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Xiuli Ju, MD, 0531-82169114, shellysdcn@hotmail.com
- Not yet recruiting
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi
Fei He, MD, 0791-86802382, hefei1944@163.com
- Not yet recruiting
Nanjing Children's Hospital Affiliated to Nanjing Medical University
Nanjin, Jiangsu
Yongjun Fang, MD, 025-83117500, fyj322@189.cn
- Not yet recruiting
Affiliated Hospital of Qingdao University
Qingdao, Shandong
Lingzhen Wang, MD, 0532-96166, hopewang2006@163.com
- Not yet recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Xiaowen Zhai, MD, 021-64931990, zhaixiaowendy@163.com
- Not yet recruiting
Shanghai Children's Hospital
Shanghai, Shanghai Municipality
Hui Jiang, MD, 021-62474880, jhui0111@126.com
- Not yet recruiting
Shenzhen Children's Hospital
Shenzhen, Shenzhen
Sixi Liu, 83936101, tiger647@126.com
- Not yet recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu
Shaoyan Hu, MD, 0512-80695102, hsyl39@126.com
- Recruiting
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Tianjin, Tianjin Municipality
Xiaofan Zhu, MD, +86 022 23909001, xfzhu@ihcams.ac.cn
Jingliao Zhang, MD, +86 22 23909196, zhangjingliao@ihcams.ac.cn
- Not yet recruiting
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Tianjin, Tianjin Municipality
Wenyu Yang, MD, 022-23909138, yangwenyu@ihcams.ac.cn
- Not yet recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Aiguo Liu, MD, 027-83663131, aiguoliu309@163.com
- Not yet recruiting
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xiaoyan Wu, MD, 027-85726114, xiaoyanw8016@163.com
- Not yet recruiting
Wuhan Children's Hospital
Wuhan, Hubei
Hao Xiong, MD, 13006107360, 22587481@qq.com
Hong Kong1 site, 1 recruiting
- Not yet recruiting
Hong Kong Children's Hospital, The Chinese University of Hong Kong
Hong Kong
Chi-kong Li, MD, (852) 3505-2849, ckli@cuhk.edu.hk
About this study
Official title: A Phase 3, Multicenter Trial for Pediatric Philadelphia Chromosome-positive B-Acute Lymphoblastic Leukemia -2025 Project
This prospective clinical trial evaluates the effectiveness and safety of "chemotherapy-light" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric/adolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the CCCG-ALL-2020 protocol
Read the detailed description
- All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen.
- OVB is combined with Vincristine and Prednisone (VP) during the first 2 weeks and with blinatumomab during the last 4 weeks of remission induction in this protocol.
- Patients will receive blinatumomab for 28 days as induction instead of CAT to improve induction response and avoid toxicity.
- All patients will receive two cycles of HDMTX+Blina-14 and 4 times of triple intrathecal therapy (TIT) throughout the consolidation 1 phase.
- To decrease the toxicities of high-dose AraC, the dosage will be reduced to 1 g/m2 in the consolidation 2 phase in contrast to 2 g/m2 in 2020 protocol.
- Throughout the early Maintenance Therapy, dexamethasone and vincristine combination will be added with either venetoclax or daunorubicin alternatively for five cycles, given after MTX and 6-MP.
- Cyclophosphamide and asparaginase are totally omitted from the entire treatment to mitigate toxicities.
- Olverembatinib concentrations are recommended to be examined (cerebrospinal fluid and peripheral blood in parallel) before OVB given, after full dosing of OVB, and/or Blina+OVB, best to match lumbar puncture assessments timepoints.
- IgH rearrangement by NGS MRD will be added as an evaluation indicator, with testing frequency matching bone marrow aspiration assessments.
- Pharmarcotyping studies are recommended at baseline if condition permits.
- For patients who cannot use full-dose blinatumomab, we will adopt the CCCG-Ph+ALL2020 protocol. complications.
- Conditions
- Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+), Childhood Leukemia, Acute Lymphoblastic
- Being tested
- olverembatinib
- Keywords
- olverembatinib, Blinatumomab, venetoclax
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olverembatinibDrug
Also called vincristine, prednisone, blinatumomab, Methotrexate
All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen.
OVB is combined with Vincristine and Prednisone (VP) during the first 2 weeks and with blinatumomab during the last 4 weeks of remission induction in this protocol.
Patients will receive blinatumomab for 28 days as induction instead of CAT to improve induction response and avoid toxicity.
All patients will receive two cycles of HDMTX+Blina-14 and 4 times of triple intrathecal therapy (TIT) throughout the consolidation 1 phase.
To decrease the toxicities of high-dose AraC, the dosage will be reduced to 1 g/m2 in the consolidation 2 phase in contrast to 2 g/m2 in 2020 protocol.
Throughout the early Maintenance Therapy, dexamethasone and vincristine combination will be added with either venetoclax or daunorubicin alternatively for five cycles, given after MTX and 6-MP.
| Study group | Role | What they receive |
|---|---|---|
| OVB+Blina+VEN+Chemo-light regimen | Experimental | All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen. Cyclophosphamide and asparaginase are totally omitted from the entire treatment to mitigate toxicities.
OVB is combined with Vincristine and Prednisone (VP) during the first 2 weeks and with blinatumomab during the last 4 weeks of remission induction in this protocol.
Patients will receive blinatumomab for 28 days as induction instead of CAT to improve induction response and avoid toxicity.
All patients will receive two cycles of HDMTX+Blina-14 and 4 times of triple intrathecal therapy (TIT) throughout the consolidation 1 phase. The dosage of AraC will be reduced to 1 g/m2 in the consolidation 2 phase.
Throughout the early Maintenance Therapy, dexamethasone and vincristine combination will be added with either venetoclax or daunorubicin alternatively for five cycles, given after MTX and 6-MP. Receives: Drug: olverembatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 48 end-of-induction measurable residual diseases (MRD48) after induction remission with olverembatinib and blinatumomab, compared to MRD46 of those treated with dasatinib plus chemotherapy induction (CCCG-ALL-2015 /2020) or from historical cohorts .
Primary analysis will be performed by one-sided (Monte-Carlo-) exact chi-square test because the objective calls for testing if the proportion of patients in the <0.01% Day 48 MRD group is higher than the historical control. The historical control of Day 46 MRD of dasatinib combination with intensive chemotherapy is 80%. It is estimated that VPO+Blinatumomab can increase the negative rate of Day 48 MRD by 10%. a total sample size of 135 provides sufficient power for the planned analyses outlined above if the true D48 MRD negativity probability is 0.90 or higher based on a one-sided alpha of 0.05.
Measured: Up to approximately 4.5 years.
Secondary outcomes (4)
Day 19 measurable residual diseases (MRD19) during induction remission with olverembatinib plus VP (VOP), compared to MRD19 of those treated with dasatinib plus 4-drug chemotherapy induction (CCCG-ALL-2015 /2020) or from historical cohorts
For this objective a one-sided comparison of probabilities and historical control rate of 40% will be made. Let p2 be the probability of achieving negative D19 MRD on the current study, then the one-sided alternative hypothesis H0: p2=40% vs. H1: p2>40% will be tested. This analysis will be performed by one-sample one-sided exact binomial test, based on a one-sided alpha of 0.025. The historical control is based on the MRD of patients treated on CCCG-ALL-2015.
Measured: Approximately 4.5 years.
Event-free survival (EFS) of patients treated with this therapy, in comparison to historical regimens.
The EFS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 2, 3 years since diagnosis). Standard error will be estimated using the default procedure in R. Follow up of the historical comparison cohort (CCCG-ALL-2020 and 2015) will continue during the course of the current trial. Comparisons of EFS will be performed using two-sided log-rank test. Multivariable regression modeling including trial (CAMS-Ph+B-ALLRegimen 2025 vs. CCCG-Ph-ALL 2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Cox models.
Measured: Approximately 7 years.
Overall survival (OS) of patients treated with this therapy, in comparison to historical regimens
The OS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 2, 3 years since diagnosis). Comparison of OS functions will be conducted using the two-sided log-rank test. Standard error will be estimated using the default procedure in R. Follow up of the historical comparison cohort (CCCG-ALL-2020 and 2015) will continue during the course of the current trial. Comparisons of OS will be performed using two-sided log-rank test. Multivariable regression modeling including trial (CAMS-Ph+B-ALL-2025 vs. CCCGALL-2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Cox models.
Measured: Approximately 7 years.
Cumulative incidence of relapse (CIR) of this therapy, in comparison to historical regimens.
CIR functions of relapse will be estimated by the Kalbafleisch-Prentice method. Follow up of the historical comparison cohort (CCCG-ALL-2020 and 2015) will continue during the course of the current trial. Comparisons of CIR will be performed by Gray's test. Multivariable regression modeling including trial (CAMS-Ph+B-ALLALL-2025 vs. CCCGALL-2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Fine-Gray models.
Measured: Approximately 7 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start28 Mar 2025
- Primary completionDec 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaofan Zhu, MD, Principal investigator, Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152041
- Sponsor's protocol ID
- IIT2025041
- Acronym
- CAMS-Ph+ B-ALL
- Status last verified
- Aug 2025
- First submitted
- 28 Mar 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Manabe A, Kawasaki H, Shimada H, Kato I, Kodama Y, Sato A, Matsumoto K, Kato K, Yabe H, Kudo K, Kato M, Saito T, Saito AM, Tsurusawa M, Horibe K. Imatinib use immediately before stem cell transplantation in children with Philadelphia chromosome-positive acute lymphoblastic leukemia: Results from Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) Study Ph(+) ALL04. Cancer Med. 2015 May;4(5):682-9. doi: 10.1002/cam4.383. Epub 2015 Jan 31.
PubMed 25641907Hum RM, Deambrosis D, Lum SH, Davies E, Bonney D, Guiver M, Turner A, Wynn RF, Hiwarkar P. Molecular monitoring of adenovirus reactivation in faeces after haematopoietic stem-cell transplantation to predict systemic infection: a retrospective cohort study. Lancet Haematol. 2018 Sep;5(9):e422-e429. doi: 10.1016/S2352-3026(18)30130-3.
PubMed 30172346Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Arico M, Rottgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. doi: 10.1016/S1470-2045(12)70377-7. Epub 2012 Aug 14.
PubMed 22898679Schultz KR, Carroll A, Heerema NA, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Zheng HW, Davies SM, Gaynon PS, Trigg M, Rutledge R, Jorstad D, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B; Children's Oncology Group. Long-term follow-up of imatinib in pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia: Children's Oncology Group study AALL0031. Leukemia. 2014 Jul;28(7):1467-71. doi: 10.1038/leu.2014.30. Epub 2014 Jan 20.
PubMed 24441288Schultz KR, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Wang C, Davies SM, Gaynon PS, Trigg M, Rutledge R, Burden L, Jorstad D, Carroll A, Heerema NA, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B. Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: a children's oncology group study. J Clin Oncol. 2009 Nov 1;27(31):5175-81. doi: 10.1200/JCO.2008.21.2514. Epub 2009 Oct 5.
PubMed 19805687Arico M, Schrappe M, Hunger SP, Carroll WL, Conter V, Galimberti S, Manabe A, Saha V, Baruchel A, Vettenranta K, Horibe K, Benoit Y, Pieters R, Escherich G, Silverman LB, Pui CH, Valsecchi MG. Clinical outcome of children with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia treated between 1995 and 2005. J Clin Oncol. 2010 Nov 1;28(31):4755-61. doi: 10.1200/JCO.2010.30.1325. Epub 2010 Sep 27.
PubMed 20876426
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter Trial for Pediatric Philadelphia Chromosome-positive B-Acute Lymphoblastic Leukemia -2025 Project
- ClinicalTrials.gov ID
- NCT07152041
- Acronym / sponsor ID
- CAMS-Ph+ B-ALL / IIT2025041
- Conditions
- Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+), Childhood Leukemia, Acute Lymphoblastic
- Keywords
- olverembatinib, Blinatumomab, venetoclax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective clinical trial evaluates the effectiveness and safety of "chemotherapy-light" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric/adolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the CCCG-ALL-2020 protocol
Detailed description
- All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen.
- OVB is combined with Vincristine and Prednisone (VP) during the first 2 weeks and with blinatumomab during the last 4 weeks of remission induction in this protocol.
- Patients will receive blinatumomab for 28 days as induction instead of CAT to improve induction response and avoid toxicity.
- All patients will receive two cycles of HDMTX+Blina-14 and 4 times of triple intrathecal therapy (TIT) throughout the consolidation 1 phase.
- To decrease the toxicities of high-dose AraC, the dosage will be reduced to 1 g/m2 in the consolidation 2 phase in contrast to 2 g/m2 in 2020 protocol.
- Throughout the early Maintenance Therapy, dexamethasone and vincristine combination will be added with either venetoclax or daunorubicin alternatively for five cycles, given after MTX and 6-MP.
- Cyclophosphamide and asparaginase are totally omitted from the entire treatment to mitigate toxicities.
- Olverembatinib concentrations are recommended to be examined (cerebrospinal fluid and peripheral blood in parallel) before OVB given, after full dosing of OVB, and/or Blina+OVB, best to match lumbar puncture assessments timepoints.
- IgH rearrangement by NGS MRD will be added as an evaluation indicator, with testing frequency matching bone marrow aspiration assessments.
- Pharmarcotyping studies are recommended at baseline if condition permits.
- For patients who cannot use full-dose blinatumomab, we will adopt the CCCG-Ph+ALL2020 protocol. complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OVB+Blina+VEN+Chemo-light regimen | Experimental | Drug: olverembatinibAll Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen. Cyclophosphamide and asparaginase are totally omitted from the entire treatment to mitigate toxicities. OVB is combined with Vincristine and Prednisone (VP) during the first 2 weeks and with blinatumomab during the last 4 weeks of remission induction in this protocol. Patients will receive blinatumomab for 28 days as induction instead of CAT to improve induction response and avoid toxicity. All patients will receive two cycles of HDMTX+Blina-14 and 4 times of triple intrathecal therapy (TIT) throughout the consolidation 1 phase. The dosage of AraC will be reduced to 1 g/m2 in the consolidation 2 phase. Throughout the early Maintenance Therapy, dexamethasone and vincristine combination will be added with either venetoclax or daunorubicin alternatively for five cycles, given after MTX and 6-MP. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age older than 1 month to younger 18 years.
- Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
- Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
Key exclusion criteria (9 listed)
- ALL evolved from CML.
- Known underlying congenital immunodeficiency or metabolic disease.
- Congenital heart disease with cardiac insufficiency.
- Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug.
- Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olverembatinibAlso: vincristine, prednisone, blinatumomab, MethotrexateAll Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen. OVB is combined with Vincristine and Prednisone (VP) during the first 2 weeks and with blinatumomab during the last 4 weeks of remission induction in this protocol. Patients will receive blinatumomab for 28 days as induction instead of CAT to improve induction response and avoid toxicity. All patients will receive two cycles of HDMTX+Blina-14 and 4 times of triple intrathecal therapy (TIT) throughout the consolidation 1 phase. To decrease the toxicities of high-dose AraC, the dosage will be reduced to 1 g/m2 in the consolidation 2 phase in contrast to 2 g/m2 in 2020 protocol. Throughout the early Maintenance Therapy, dexamethasone and vincristine combination will be added with either venetoclax or daunorubicin alternatively for five cycles, given after MTX and 6-MP. | Drug | OVB+Blina+VEN+Chemo-light regimen |
Primary outcome
Day 48 end-of-induction measurable residual diseases (MRD48) after induction remission with olverembatinib and blinatumomab, compared to MRD46 of those treated with dasatinib plus chemotherapy induction (CCCG-ALL-2015 /2020) or from historical cohorts .
Time frame: Up to approximately 4.5 years.
Primary analysis will be performed by one-sided (Monte-Carlo-) exact chi-square test because the objective calls for testing if the proportion of patients in the <0.01% Day 48 MRD group is higher than the historical control. The historical control of Day 46 MRD of dasatinib combination with intensive chemotherapy is 80%. It is estimated that VPO+Blinatumomab can increase the negative rate of Day 48 MRD by 10%. a total sample size of 135 provides sufficient power for the planned analyses outlined above if the true D48 MRD negativity probability is 0.90 or higher based on a one-sided alpha of 0.05.
4 secondary outcomes
Day 19 measurable residual diseases (MRD19) during induction remission with olverembatinib plus VP (VOP), compared to MRD19 of those treated with dasatinib plus 4-drug chemotherapy induction (CCCG-ALL-2015 /2020) or from historical cohorts
Time frame: Approximately 4.5 years.
Event-free survival (EFS) of patients treated with this therapy, in comparison to historical regimens.
Time frame: Approximately 7 years.
Overall survival (OS) of patients treated with this therapy, in comparison to historical regimens
Time frame: Approximately 7 years.
Cumulative incidence of relapse (CIR) of this therapy, in comparison to historical regimens.
Time frame: Approximately 7 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 25641907Manabe A, Kawasaki H, Shimada H, Kato I, Kodama Y, Sato A, Matsumoto K, Kato K, Yabe H, Kudo K, Kato M, Saito T, Saito AM, Tsurusawa M, Horibe K. Imatinib use immediately before stem cell transplantation in children with Philadelphia chromosome-positive acute lymphoblastic leukemia: Results from Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) Study Ph(+) ALL04. Cancer Med. 2015 May;4(5):682-9. doi: 10.1002/cam4.383. Epub 2015 Jan 31.
- Background: PubMed 30172346Hum RM, Deambrosis D, Lum SH, Davies E, Bonney D, Guiver M, Turner A, Wynn RF, Hiwarkar P. Molecular monitoring of adenovirus reactivation in faeces after haematopoietic stem-cell transplantation to predict systemic infection: a retrospective cohort study. Lancet Haematol. 2018 Sep;5(9):e422-e429. doi: 10.1016/S2352-3026(18)30130-3.
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- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaofan Zhu, MD principal investigator
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olverembatinib in people with Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+) and Childhood Leukemia, Acute Lymphoblastic, run by Institute of Hematology & Blood Diseases Hospital, China at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingliao Zhang, MD (+86 22 23909196, zhangjingliao@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 48 end-of-induction measurable residual diseases (MRD48) after induction remission with olverembatinib and blinatumomab, compared to MRD46 of those treated with dasatinib plus chemotherapy induction (CCCG-ALL-2015 /2020) or from historical cohorts . (time frame: Up to approximately 4.5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07152041, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.