Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL
NCT ID: NCT06387121
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
53 participants
INTERVENTIONAL
2024-04-02
2028-12-31
Brief Summary
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Detailed Description
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The first cycle of induction therapy is administered with Inotuzumab ozogamicin (INO), Venetoclax (VEN), and a combination of low-dose chemotherapy. The second cycle of induction therapy is Blinatumomab (Blino) plus VEN regimen. Alternatively, the first cycle of induction therapy is a combination of VEN and low-dose chemotherapy, and the second cycle of induction therapy is methotrexate (MTX) plus cytarabine (Ara-C) plus VEN regimen. Subsequent consolidation and maintenance therapy consist of low-dose chemotherapy, Blino, and VEN. Patients can receive chimeric antigen receptor T-Cell (CAR-T) Immunotherapy or allogeneic hematopoietic stem cell transplantation (HSCT) or receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation chemotherapy. Study patients are scheduled for follow-up for at least 5 years after the end of maintenance therapy.
The purpose of current study is to determine the efficacy and safety of low-dose chemotherapy combined with immuno-targeted drugs in newly diagnosed adult patients with Ph- B-ALL.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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low-dose chemotherapy, Venetoclax combined with immuno-targeted drugs
The cycle of induction therapy is administered with immuno-targeted drugs (including Inotuzumab ozogamicin and/or Blinatumomab), a combination of low-dose chemotherapy (including vincristine, cyclophosphamide, dexamethasone, methotrexate and cytarabine) and Venetoclax (VEN).
Vincristine
Anti-tumor alkaloids
Cyclophosphamide
Alkylating agent
Dexamethasone
Glucocorticoids
Venetoclax
Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Inotuzumab ozogamicin
A humanized monoclonal antibody-drug conjugate targeting CD22
Blinatumomab
Bi-specific anti-CD19/CD3 antibodies
6-mercaptopurine
Cell cycle-specific antitumor drug
Methotrexate
Antifolate antineoplastic drug
Cytarabine
Pyrimidine antimetabolites
Prednisone
Glucocorticoids
low-dose chemotherapy combined with Venetoclax
The cycle of induction therapy is administered with a combination of low-dose chemotherapy and VEN.
Vincristine
Anti-tumor alkaloids
Cyclophosphamide
Alkylating agent
Dexamethasone
Glucocorticoids
Venetoclax
Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
6-mercaptopurine
Cell cycle-specific antitumor drug
Methotrexate
Antifolate antineoplastic drug
Cytarabine
Pyrimidine antimetabolites
Prednisone
Glucocorticoids
Interventions
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Vincristine
Anti-tumor alkaloids
Cyclophosphamide
Alkylating agent
Dexamethasone
Glucocorticoids
Venetoclax
Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Inotuzumab ozogamicin
A humanized monoclonal antibody-drug conjugate targeting CD22
Blinatumomab
Bi-specific anti-CD19/CD3 antibodies
6-mercaptopurine
Cell cycle-specific antitumor drug
Methotrexate
Antifolate antineoplastic drug
Cytarabine
Pyrimidine antimetabolites
Prednisone
Glucocorticoids
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. CD22 positive tumor cells
3. ≥18 years of age
4. Estimated survival ≥3 months
5. Consent and effective contraception for men and women of childbearing potential
6. Understanding and signing of informed consent forms and agreement to comply with study requirements.
Exclusion Criteria
2. acute leukemias of ambiguous lineage
3. pregnant women
4. severe uncontrolled active infection
5. previous history of chronic liver disease (e.g. cirrhosis) or venous occlusive liver disease (VOD) or sinus obstruction syndrome (SOS)
6. History of clinically significant ventricular arrhythmia, syncope of unknown origin (not vasovagal) or sinoatrial block or higher degree atrioventricular (AV) block Chronic bradycardia state (unless permanent pacemaker implanted)
7. New or chronic hepatitis B or C infection (positive for hepatitis B surface antigen and anti-hepatitis C antibody, respectively) or known HIV seropositivity. HIV testing may need to be performed according to local regulations or practices
8. Psychiatric disorders likely to prevent the subject from completing treatment or informed consent
9. Other conditions considered unsuitable for the study by the investigator.
18 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Principal Investigators
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Jianxiang Wang
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Terwilliger T, Abdul-Hay M. Acute lymphoblastic leukemia: a comprehensive review and 2017 update. Blood Cancer J. 2017 Jun 30;7(6):e577. doi: 10.1038/bcj.2017.53.
Pui CH, Yang JJ, Hunger SP, Pieters R, Schrappe M, Biondi A, Vora A, Baruchel A, Silverman LB, Schmiegelow K, Escherich G, Horibe K, Benoit YC, Izraeli S, Yeoh AE, Liang DC, Downing JR, Evans WE, Relling MV, Mullighan CG. Childhood Acute Lymphoblastic Leukemia: Progress Through Collaboration. J Clin Oncol. 2015 Sep 20;33(27):2938-48. doi: 10.1200/JCO.2014.59.1636. Epub 2015 Aug 24.
Boissel N, Auclerc MF, Lheritier V, Perel Y, Thomas X, Leblanc T, Rousselot P, Cayuela JM, Gabert J, Fegueux N, Piguet C, Huguet-Rigal F, Berthou C, Boiron JM, Pautas C, Michel G, Fiere D, Leverger G, Dombret H, Baruchel A. Should adolescents with acute lymphoblastic leukemia be treated as old children or young adults? Comparison of the French FRALLE-93 and LALA-94 trials. J Clin Oncol. 2003 Mar 1;21(5):774-80. doi: 10.1200/JCO.2003.02.053. Epub 2003 Mar 1.
O'Brien S, Thomas DA, Ravandi F, Faderl S, Pierce S, Kantarjian H. Results of the hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone regimen in elderly patients with acute lymphocytic leukemia. Cancer. 2008 Oct 15;113(8):2097-101. doi: 10.1002/cncr.23819.
Geyer MB, Hsu M, Devlin SM, Tallman MS, Douer D, Park JH. Overall survival among older US adults with ALL remains low despite modest improvement since 1980: SEER analysis. Blood. 2017 Mar 30;129(13):1878-1881. doi: 10.1182/blood-2016-11-749507. Epub 2017 Jan 25. No abstract available.
Maury S, Chevret S, Thomas X, Heim D, Leguay T, Huguet F, Chevallier P, Hunault M, Boissel N, Escoffre-Barbe M, Hess U, Vey N, Pignon JM, Braun T, Marolleau JP, Cahn JY, Chalandon Y, Lheritier V, Beldjord K, Bene MC, Ifrah N, Dombret H; for GRAALL. Rituximab in B-Lineage Adult Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Sep 15;375(11):1044-53. doi: 10.1056/NEJMoa1605085.
Kantarjian H, Stein A, Gokbuget N, Fielding AK, Schuh AC, Ribera JM, Wei A, Dombret H, Foa R, Bassan R, Arslan O, Sanz MA, Bergeron J, Demirkan F, Lech-Maranda E, Rambaldi A, Thomas X, Horst HA, Bruggemann M, Klapper W, Wood BL, Fleishman A, Nagorsen D, Holland C, Zimmerman Z, Topp MS. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med. 2017 Mar 2;376(9):836-847. doi: 10.1056/NEJMoa1609783.
Other Identifiers
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IIT2023060
Identifier Type: -
Identifier Source: org_study_id