Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07493161 for Ph+ ALL is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL 100 Immunotherapy Randomized Open-Label Overall Survival
Clinical Trial NCT07493161 is an interventional study for Ph+ ALL and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 100 participants. Led by Institute of Hematology & Blood Diseases Hospital, China, this study is expected to complete by 30 March 2030. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
This is a prospective, open-label, randomized controlled trial to evaluate the efficacy and safety of low-intensity chemotherapy combined with targeted agents (venetoclax and blinatumomab) in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Patients will be randomized to receive or not receive venetoclax during the first three cycles of induction and consolidation therapy. All ...Show More
Detailed Description
Background: Ph+ ALL is a high-risk subtype of adult ALL. Although outcomes have improved with TKI-based therapy, achieving early deep molecular response remains critical for long-term survival. Novel combinations with BCL2 inhibitor venetoclax and CD3-CD19 bispecific antibody blinatumomab may further deepen responses.
Objective: To determine whether adding venetoclax to a low-intensity chemotherapy backbone (vincris...
Show MoreOfficial Title
Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study
Conditions
Ph+ ALLOther Study IDs
- IIT2026022
NCT ID Number
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2030-03-30
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorStandard Therapy (Chemotherapy + Olverembatinib) Patients receive a backbone of low-intensity chemotherapy combined with the third-generation TKI olverembatinib(OVB) .
Induction : Vincristine D1,8,15,22; Prednisone D1-28; Olverembatinib (40mg every other day) D1-28；
Consolidation 1 \& 2: Olverembatinib D1-28; Prednisone D1-14；Vincristine D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1.
Subsequent Chemotherapy: I...Show More | Olverembatinib Third-generation tyrosine kinase inhibitor (TKI) targeting BCR-ABL1, including T315I mutation.nduction \& Consolidation: 40mg every other day.
After achieving CMR: Reduced to 20mg every other day during maintenance. Blinatumomab CD19/CD3 bispecific T-cell engager (BiTE). Optional add-on therapy.Start: After first consolidation.
Duration: 1-4 cycles (each cycle = 28 days), intercalated with chemotherapy cycles.
Note: If ≥3 cycles given,cycle 8 and 9 are omitted. Chemotherapy Backbone Regimens Induction (VPO/VPVO): Vincristine + Prednisone + Olverembatinib (± Venetoclax).
Consolidation (VOVP/OVP): Vincristine +Olverembatinib + Prednisone (± Venetoclax).
HD-MTX: High-dose methotrexate with leucovorin rescue in cycle 4,6,8.
ID-AraC: Intermediate-dose cytarabine in cycle 5,7,9. CAR-T Cell Therapy After second consolidation (optional pathway). Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Recommended for patients with MRD ≥0.01% after two treatment blocks. |
ExperimentalVenetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax) Patients receive the same backbone as the Control Arm plus the BCL2 inhibitor venetoclax (100mg D1,200 mg D2，400 mg D3-28) for the first three treatment blocks.
Consolidation 1 \& 2 (OP, 4 weeks each): Olverembatinib (40mg every other day) D1-28; Prednisone D1-14；Vincristine (VCR) D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1.
Subsequent Chemotherapy: Includes Hi...Show More | Olverembatinib Third-generation tyrosine kinase inhibitor (TKI) targeting BCR-ABL1, including T315I mutation.nduction \& Consolidation: 40mg every other day.
After achieving CMR: Reduced to 20mg every other day during maintenance. Venetoclax BCL-2 inhibitor. Used only in the experimental arm.Induction: Ramp-up: 100mg D1, 200mg D2, 400mg D3-28.
Consolidation: 400mg D1-7. Blinatumomab CD19/CD3 bispecific T-cell engager (BiTE). Optional add-on therapy.Start: After first consolidation.
Duration: 1-4 cycles (each cycle = 28 days), intercalated with chemotherapy cycles.
Note: If ≥3 cycles given,cycle 8 and 9 are omitted. Chemotherapy Backbone Regimens Induction (VPO/VPVO): Vincristine + Prednisone + Olverembatinib (± Venetoclax).
Consolidation (VOVP/OVP): Vincristine +Olverembatinib + Prednisone (± Venetoclax).
HD-MTX: High-dose methotrexate with leucovorin rescue in cycle 4,6,8.
ID-AraC: Intermediate-dose cytarabine in cycle 5,7,9. CAR-T Cell Therapy After second consolidation (optional pathway). Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Recommended for patients with MRD ≥0.01% after two treatment blocks. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Rate of BCR::ABL1 ≤0.01% at 90 days (after three cycles of treatment) | up to 90 days | |
Event-Free Survival | up to 5 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall Survival | up to 5 years | |
Relapse-Free Survival | up to 5 years | |
Cumulative incidence of molecular relapse | up to 5 years | |
Cumulative incidence of hematologic relapse | up to 5 years | |
Proportion of patients with next-generation sequencing minimal residual disease <0.01% after three cycles of treatment (90 days) | up to 90 days | |
Proportion of patients with next-generation sequencing minimal residual disease <0.01% at the end of consolidation therapy | up to 1 year | |
Incidence of treatment-related cardiovascular events | up to 5 years from the initiation of treatment | |
Proportion of patients with BCR::ABL1 ≤0.01% at completion of consolidation therapy | up to 90 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
14 Years
Eligible Sexes
All
- Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).
- Age ≥ 14 years.
- ECOG performance status ≤ 2.
- Adequate organ function: Total bilirubin <1.5x ULN; AST/ALT ≤2.5x ULN; Serum creatinine <2x ULN; Cardiac enzymes <2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) >45%.
- Male and female patients of childbearing potential must agree to use effective contraception.
- Signed informed consent.
- Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.
- Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).
- Myocardial infarction within 12 months prior to enrollment; uncontrolled/unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.
- Uncontrolled active severe infection.
- Active psychiatric illness that may hinder treatment completion or informed consent.
- Any other condition deemed unsuitable for the study by the investigator.
Institute of Hematology & Blood Diseases Hospital, ChinaStudy Central Contact
Contact: Hui Wei, MD, 13132507161, [email protected]
No location data.