Acute Lymphoblastic Leukemia, AdultPhase 2/3NCT07059156
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
A Phase 2/3 study testing Induction Therapy Regimen, Pre-Treatment Regimen and Post-CR Treatment in people with Acute Lymphoblastic Leukemia, Adult, run by Shanxi Bethune Hospital at 1 site in China.
Trial summary
This study aims to evaluate an integrated treatment protocol for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) to improve treatment efficacy and survival… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Adult
- What is being tested?
- Induction Therapy Regimen, Pre-Treatment Regimen and Post-CR Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to Jul 2027
- Phase
- Phase 2/3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 60 years；
- Diagnosis must comply with the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2024 Edition), requiring MICM (Morphology, Immunology, Cytogenetics, and Molecular genetics) integration and WHO 2022 (5th edition) classification standards. The minimal diagnostic workup must include morphological assessment and immunophenotyping to differentiate ALL from acute myeloid leukemia (AML). All patients shall undergo bone marrow aspiration plus biopsy at initial diagnosis. A definitive ALL diagnosis requires ≥20% blasts/immature lymphocytes in bone marrow (Note: Patients with <20% blasts due to fever or glucocorticoid pretreatment require comprehensive evaluation incorporating medical history and ancillary tests for differential diagnosis)；
- ECOG Performance Status: 0-2
Who cannot join
- Intracranial hemorrhage
- Pregnancy
- Psychiatric disorders or other conditions compromising protocol compliance
- Severe cardiac arrhythmia with ECG abnormalities (QTc >500 ms)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
Tao Wang, Dr., 13835175119, wangtao99699@163.com
About this study
Official title: Multicenter Study on Integrated Treatment Regimen of Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Lymphoblastic Leukemia
This study aims to evaluate an integrated treatment protocol for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) to improve treatment efficacy and survival rates. The single-arm, open-label, multicenter study will enroll 50 newly diagnosed patients aged 18-60 years. The induction phase employs the VICP+VEN regimen (vindesine, idarubicin, cyclophosphamide, prednisone combined with venetoclax), followed by consolidation therapy with either Hyper-CVAD or CAM protocols, with eligible patients proceeding to allo-HSCT. Primary endpoints include disease-free survival (DFS) and complete remission (CR) rates, while secondary endpoints encompass relapse rate, overall survival (OS), and safety. Patients will be followed for 2 years with regular monitoring of minimal residual disease (MRD) and adverse events. The protocol is designed to reduce relapse risk through intensive therapy and transplantation, offering a potential cure for high-risk patients.The goal is to complete the entire treatment within 4 months after diagnosis.
Read the detailed description
- Intervention Measures 1.1 Induction Therapy Regimen
VICP+VEN regimen:
- Vindesine: 3 mg/m²/day (max 4 mg), administered on days 1, 8, 15, 22.
- Idarubicin (IDA): 8 mg/m², days 1, 8, 15, 22.
- Cyclophosphamide (CTX): 500 mg/m², days 7, 21.
- Prednisone: 1 mg/kg/day, days 1-14; 0.5 mg/kg/day, days 15-28
- Venetoclax (VEN) 8-day ramp-up: Day 1: 100 mg, Day 2: 200 mg, Days 3-8: 400 mg/day 1.2 Pre-Treatment Regimen
Indications for pre-treatment:
- WBC ≥30×10⁹/L, or significant hepatosplenomegaly/lymphadenopathy.
- Laboratory signs of tumor lysis syndrome (e.g., electrolyte abnormalities).
Pre-treatment protocol:
- Glucocorticoids (e.g., prednisone or dexamethasone): Prednisone 1 mg/kg/day (PO/IV) for 3-5 days.
- Optional addition of CTX: 200 mg/m²/day IV for 3-5 days. 1.3 Post-CR Treatment
Principles:
- MRD-positive or rising: Administer blinatumomab (CD19/CD3 bispecific antibody) for residual disease clearance, followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- MRD-negative/unknown: Continue multi-agent chemotherapy ± blinatumomab consolidation. Allo-HSCT for patients with high-risk clinical/genetic features. 1.4 Post-CR Consolidation Regimens ① Hyper-CVAD-B (Methotrexate/Cytarabine-based):
- Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH >7.0) and leucovorin rescue.
- Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses).
- Dexamethasone: 40 mg/day (PO/IV, Days 1-4).
- Cycle interval: 21-28 days (alternating with other regimens).
- CAM Regimen:
- CTX: 750 mg/m² IV (split over 2 days).
- Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks).
- 6-MP: 50-75 mg/m²/day fasting (7-14 days PO). 1.5 Transplant-Eligible Subsequent Therapy
- Allo-HSCT for eligible patients after induction.
- Conditioning regimen: TBI-VP16-CY.
- Donor priority: HLA-matched sibling donor (MSD), Matched unrelated donor (MUD), Haploidentical donor (Haplo). (Consider age/donor health status). 1.6 Allo-HSCT Protocol 1.6.1 Conditioning Regimen (TBI-VP16-Cy/ATG):
- TBI: 5 Gy (Days -7 to -6).
- VP16: 10 mg/kg/day (Days -5 to -4).
- CTX: 30 mg/kg/day (Days -3 to -2).
- ATG: 7.5 mg/kg/day (Days -5 to -2). 1.6.2 GVHD Prophylaxis:
- Basiliximab (anti-CD25 mAb): 50 mg (Days +1, +4).
- Standard regimen: Cyclosporine (CsA): IV: 2 mg/kg/day (start Day -9; target level 150-250 μg/L). PO: 3-5 mg/kg/day BID (switch delayed until Day +10 if no aGVHD); Mycophenolate mofetil (MMF) + short-course methotrexate. 1.7 Non-Transplant Maintenance Therapy Options:
- Hyper-CVAD-B (Methotrexate/Cytarabine-based):
- Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH >7.0) and leucovorin rescue.
- Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses).
- Dexamethasone: 40 mg/day (PO/IV, Days 1-4).
- Cycle interval: 21-28 days (alternating with other regimens).
- CAM Regimen:
- CTX: 750 mg/m² IV (split over 2 days).
- Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks).
- 6-MP: 50-75 mg/m²/day fasting (7-14 days PO).
- Maintenance (6-MP/MTX alternating with V-Dex): 6-MP: 75 mg/m²/day at bedtime (Days 1-21); MTX: 20 mg/m² IM weekly × 3 weeks.*Adjust doses to maintain WBC ~3×10⁹/L, ANC 1.0-1.5×10⁹/L.*
- Conditions
- Acute Lymphoblastic Leukemia, Adult
- Being tested
- Induction Therapy Regimen, Pre-Treatment Regimen, Post-CR Treatment, Post-CR Consolidation Regimens, Transplant-Eligible Subsequent Therapy
- 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.
Induction Therapy RegimenDrug
VICP+VEN regimen:
- Vindesine: 3 mg/m²/day (max 4 mg), administered on days 1, 8, 15, 22.
- Idarubicin (IDA): 8 mg/m², days 1, 8, 15, 22.
- Cyclophosphamide (CTX): 500 mg/m², days 7, 21.
- Prednisone: 1 mg/kg/day, days 1-14; 0.5 mg/kg/day, days 15-28
- Venetoclax (VEN) 8-day ramp-up: Day 1: 100 mg, Day 2: 200 mg, Days 3-8: 400 mg/day
Pre-Treatment RegimenDrug
Indications for pre-treatment:
- WBC ≥30×10⁹/L, or significant hepatosplenomegaly/lymphadenopathy.
- Laboratory signs of tumor lysis syndrome (e.g., electrolyte abnormalities).
Pre-treatment protocol:
- Glucocorticoids (e.g., prednisone or dexamethasone): Prednisone 1 mg/kg/day (PO/IV) for 3-5 days.
- Optional addition of CTX: 200 mg/m²/day IV for 3-5 days.
Post-CR TreatmentOther
Principles:
- MRD-positive or rising: Administer blinatumomab (CD19/CD3 bispecific antibody) for residual disease clearance, followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- MRD-negative/unknown: Continue multi-agent chemotherapy ± blinatumomab consolidation. Allo-HSCT for patients with high-risk clinical/genetic features.
Post-CR Consolidation RegimensDrug
① Hyper-CVAD-B (Methotrexate/Cytarabine-based):
- Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH >7.0) and leucovorin rescue.
- Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses).
- Dexamethasone: 40 mg/day (PO/IV, Days 1-4).
- Cycle interval: 21-28 days (alternating with other regimens). ② CAM Regimen:
- CTX: 750 mg/m² IV (split over 2 days).
- Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks).
- 6-MP: 50-75 mg/m²/day fasting (7-14 days PO).
Transplant-Eligible Subsequent TherapyOther
- Allo-HSCT for eligible patients after induction.
- Conditioning regimen: TBI-VP16-CY.
- Donor priority: HLA-matched sibling donor (MSD), Matched unrelated donor (MUD), Haploidentical donor (Haplo).(Consider age/donor health status).
Allo-HSCT ProtocolOther
1.6.1 Conditioning Regimen (TBI-VP16-Cy/ATG):
- TBI: 5 Gy (Days -7 to -6).
- VP16: 10 mg/kg/day (Days -5 to -4).
- CTX: 30 mg/kg/day (Days -3 to -2).
- ATG: 7.5 mg/kg/day (Days -5 to -2). 1.6.2 GVHD Prophylaxis:
- Basiliximab (anti-CD25 mAb): 50 mg (Days +1, +4).
- Standard regimen: Cyclosporine (CsA): IV: 2 mg/kg/day (start Day -9; target level 150-250 μg/L). PO: 3-5 mg/kg/day BID (switch delayed until Day +10 if no aGVHD); Mycophenolate mofetil (MMF) + short-course methotrexate.
Non-Transplant Maintenance Therapy OptionsOther
① Hyper-CVAD-B (Methotrexate/Cytarabine-based):
- Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH >7.0) and leucovorin rescue.
- Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses).
- Dexamethasone: 40 mg/day (PO/IV, Days 1-4).
- Cycle interval: 21-28 days (alternating with other regimens). ② CAM Regimen:
- CTX: 750 mg/m² IV (split over 2 days).
- Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks).
- 6-MP: 50-75 mg/m²/day fasting (7-14 days PO).
- Maintenance (6-MP/MTX alternating with V-Dex): 6-MP: 75 mg/m²/day at bedtime (Days 1-21); MTX: 20 mg/m² IM weekly × 3 weeks.*Adjust doses to maintain WBC ~3×10⁹/L, ANC 1.0-1.5×10⁹/L.*
| Study group | Role | What they receive |
|---|---|---|
| Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL | Experimental | Not described Receives: Drug: Induction Therapy Regimen; Drug: Pre-Treatment Regimen; Other: Post-CR Treatment; Drug: Post-CR Consolidation Regimens; Other: Transplant-Eligible Subsequent Therapy; Other: Allo-HSCT Protocol; Other: Non-Transplant Maintenance Therapy Options |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Measured: 24 months
Complete remission (CR) rate
Measured: 24 months
Partial remission (PR) rate
Measured: 24 months
Non-remission (NR) rate
Measured: 24 months
CR with incomplete hematologic recovery (CRi)
Measured: 24 months
Secondary outcomes (6)
Relapse rate
Measured: 24 months
Treatment-related mortality（TRM）
Measured: 24 months
Overall Survival（OS）
Measured: 24 months
Event-Free Survival（EFS）
Measured: 24 months
Adverse Event
Measured: 24 months
Mortality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, AdultStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059156
- Sponsor's protocol ID
- ShanxiBethuneH1
- Status last verified
- Jun 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Integrated Treatment Regimen of Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07059156
- Acronym / sponsor ID
- ShanxiBethuneH1
- Conditions
- Acute Lymphoblastic Leukemia, Adult
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Jul 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 study aims to evaluate an integrated treatment protocol for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) to improve treatment efficacy and survival rates. The single-arm, open-label, multicenter study will enroll 50 newly diagnosed patients aged 18-60 years. The induction phase employs the VICP+VEN regimen (vindesine, idarubicin, cyclophosphamide, prednisone combined with venetoclax), followed by consolidation therapy with either Hyper-CVAD or CAM protocols, with eligible patients proceeding to allo-HSCT. Primary endpoints include disease-free survival (DFS) and complete remission (CR) rates, while secondary endpoints encompass relapse rate, overall survival (OS), and safety. Patients will be followed for 2 years with regular monitoring of minimal residual disease (MRD) and adverse events. The protocol is designed to reduce relapse risk through intensive therapy and transplantation, offering a potential cure for high-risk patients.The goal is to complete the entire treatment within 4 months after diagnosis.
Detailed description
- Intervention Measures 1.1 Induction Therapy Regimen
VICP+VEN regimen:
- Vindesine: 3 mg/m²/day (max 4 mg), administered on days 1, 8, 15, 22.
- Idarubicin (IDA): 8 mg/m², days 1, 8, 15, 22.
- Cyclophosphamide (CTX): 500 mg/m², days 7, 21.
- Prednisone: 1 mg/kg/day, days 1-14; 0.5 mg/kg/day, days 15-28
- Venetoclax (VEN) 8-day ramp-up: Day 1: 100 mg, Day 2: 200 mg, Days 3-8: 400 mg/day 1.2 Pre-Treatment Regimen
Indications for pre-treatment:
- WBC ≥30×10⁹/L, or significant hepatosplenomegaly/lymphadenopathy.
- Laboratory signs of tumor lysis syndrome (e.g., electrolyte abnormalities).
Pre-treatment protocol:
- Glucocorticoids (e.g., prednisone or dexamethasone): Prednisone 1 mg/kg/day (PO/IV) for 3-5 days.
- Optional addition of CTX: 200 mg/m²/day IV for 3-5 days. 1.3 Post-CR Treatment
Principles:
- MRD-positive or rising: Administer blinatumomab (CD19/CD3 bispecific antibody) for residual disease clearance, followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- MRD-negative/unknown: Continue multi-agent chemotherapy ± blinatumomab consolidation. Allo-HSCT for patients with high-risk clinical/genetic features. 1.4 Post-CR Consolidation Regimens ① Hyper-CVAD-B (Methotrexate/Cytarabine-based):
- Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH >7.0) and leucovorin rescue.
- Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses).
- Dexamethasone: 40 mg/day (PO/IV, Days 1-4).
- Cycle interval: 21-28 days (alternating with other regimens).
- CAM Regimen:
- CTX: 750 mg/m² IV (split over 2 days).
- Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks).
- 6-MP: 50-75 mg/m²/day fasting (7-14 days PO). 1.5 Transplant-Eligible Subsequent Therapy
- Allo-HSCT for eligible patients after induction.
- Conditioning regimen: TBI-VP16-CY.
- Donor priority: HLA-matched sibling donor (MSD), Matched unrelated donor (MUD), Haploidentical donor (Haplo). (Consider age/donor health status). 1.6 Allo-HSCT Protocol 1.6.1 Conditioning Regimen (TBI-VP16-Cy/ATG):
- TBI: 5 Gy (Days -7 to -6).
- VP16: 10 mg/kg/day (Days -5 to -4).
- CTX: 30 mg/kg/day (Days -3 to -2).
- ATG: 7.5 mg/kg/day (Days -5 to -2). 1.6.2 GVHD Prophylaxis:
- Basiliximab (anti-CD25 mAb): 50 mg (Days +1, +4).
- Standard regimen: Cyclosporine (CsA): IV: 2 mg/kg/day (start Day -9; target level 150-250 μg/L). PO: 3-5 mg/kg/day BID (switch delayed until Day +10 if no aGVHD); Mycophenolate mofetil (MMF) + short-course methotrexate. 1.7 Non-Transplant Maintenance Therapy Options:
- Hyper-CVAD-B (Methotrexate/Cytarabine-based):
- Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH >7.0) and leucovorin rescue.
- Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses).
- Dexamethasone: 40 mg/day (PO/IV, Days 1-4).
- Cycle interval: 21-28 days (alternating with other regimens).
- CAM Regimen:
- CTX: 750 mg/m² IV (split over 2 days).
- Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks).
- 6-MP: 50-75 mg/m²/day fasting (7-14 days PO).
- Maintenance (6-MP/MTX alternating with V-Dex): 6-MP: 75 mg/m²/day at bedtime (Days 1-21); MTX: 20 mg/m² IM weekly × 3 weeks.*Adjust doses to maintain WBC ~3×10⁹/L, ANC 1.0-1.5×10⁹/L.*
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL | Experimental | Drug: Induction Therapy Regimen, Drug: Pre-Treatment Regimen, Other: Post-CR Treatment, Drug: Post-CR Consolidation Regimens, Other: Transplant-Eligible Subsequent Therapy, Other: Allo-HSCT Protocol, Other: Non-Transplant Maintenance Therapy Options |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18 to 60 years；
- Diagnosis must comply with the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2024 Edition), requiring MICM (Morphology, Immunology, Cytogenetics, and Molecular genetics) integration and WHO 2022 (5th edition) classification standards. The minimal diagnostic workup must include morphological assessment and immunophenotyping to differentiate ALL from acute myeloid leukemia (AML). All patients shall undergo bone marrow aspiration plus biopsy at initial diagnosis. A definitive ALL diagnosis requires ≥20% blasts/immature lymphocytes in bone marrow (Note: Patients with <20% blasts due to fever or glucocorticoid pretreatment require comprehensive evaluation incorporating medical history and ancillary tests for differential diagnosis)；
- ECOG Performance Status: 0-2
Key exclusion criteria (4 listed)
- Intracranial hemorrhage
- Pregnancy
- Psychiatric disorders or other conditions compromising protocol compliance
- Severe cardiac arrhythmia with ECG abnormalities (QTc >500 ms)
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 |
|---|---|---|
| Induction Therapy RegimenVICP+VEN regimen: * Vindesine: 3 mg/m²/day (max 4 mg), administered on days 1, 8, 15, 22. * Idarubicin (IDA): 8 mg/m², days 1, 8, 15, 22. * Cyclophosphamide (CTX): 500 mg/m², days 7, 21. * Prednisone: 1 mg/kg/day, days 1-14; 0.5 mg/kg/day, days 15-28 * Venetoclax (VEN) 8-day ramp-up: Day 1: 100 mg, Day 2: 200 mg, Days 3-8: 400 mg/day | Drug | Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL |
| Pre-Treatment RegimenIndications for pre-treatment: * WBC ≥30×10⁹/L, or significant hepatosplenomegaly/lymphadenopathy. * Laboratory signs of tumor lysis syndrome (e.g., electrolyte abnormalities). Pre-treatment protocol: * Glucocorticoids (e.g., prednisone or dexamethasone): Prednisone 1 mg/kg/day (PO/IV) for 3-5 days. * Optional addition of CTX: 200 mg/m²/day IV for 3-5 days. | Drug | Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL |
| Post-CR TreatmentPrinciples: 1. MRD-positive or rising: Administer blinatumomab (CD19/CD3 bispecific antibody) for residual disease clearance, followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). 2. MRD-negative/unknown: Continue multi-agent chemotherapy ± blinatumomab consolidation. Allo-HSCT for patients with high-risk clinical/genetic features. | Other | Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL |
| Post-CR Consolidation Regimens① Hyper-CVAD-B (Methotrexate/Cytarabine-based): * Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH >7.0) and leucovorin rescue. * Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses). * Dexamethasone: 40 mg/day (PO/IV, Days 1-4). * Cycle interval: 21-28 days (alternating with other regimens). ② CAM Regimen: * CTX: 750 mg/m² IV (split over 2 days). * Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks). * 6-MP: 50-75 mg/m²/day fasting (7-14 days PO). | Drug | Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL |
| Transplant-Eligible Subsequent Therapy* Allo-HSCT for eligible patients after induction. * Conditioning regimen: TBI-VP16-CY. * Donor priority: HLA-matched sibling donor (MSD), Matched unrelated donor (MUD), Haploidentical donor (Haplo).(Consider age/donor health status). | Other | Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL |
| Allo-HSCT Protocol1.6.1 Conditioning Regimen (TBI-VP16-Cy/ATG): * TBI: 5 Gy (Days -7 to -6). * VP16: 10 mg/kg/day (Days -5 to -4). * CTX: 30 mg/kg/day (Days -3 to -2). * ATG: 7.5 mg/kg/day (Days -5 to -2). 1.6.2 GVHD Prophylaxis: * Basiliximab (anti-CD25 mAb): 50 mg (Days +1, +4). * Standard regimen: Cyclosporine (CsA): IV: 2 mg/kg/day (start Day -9; target level 150-250 μg/L). PO: 3-5 mg/kg/day BID (switch delayed until Day +10 if no aGVHD); Mycophenolate mofetil (MMF) + short-course methotrexate. | Other | Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL |
| Non-Transplant Maintenance Therapy Options① Hyper-CVAD-B (Methotrexate/Cytarabine-based): * Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH >7.0) and leucovorin rescue. * Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses). * Dexamethasone: 40 mg/day (PO/IV, Days 1-4). * Cycle interval: 21-28 days (alternating with other regimens). ② CAM Regimen: * CTX: 750 mg/m² IV (split over 2 days). * Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks). * 6-MP: 50-75 mg/m²/day fasting (7-14 days PO). * Maintenance (6-MP/MTX alternating with V-Dex): 6-MP: 75 mg/m²/day at bedtime (Days 1-21); MTX: 20 mg/m² IM weekly × 3 weeks.*Adjust doses to maintain WBC ~3×10⁹/L, ANC 1.0-1.5×10⁹/L.* | Other | Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL |
Primary outcome
Disease-free survival (DFS)
Time frame: 24 months
Complete remission (CR) rate
Time frame: 24 months
Partial remission (PR) rate
Time frame: 24 months
Non-remission (NR) rate
Time frame: 24 months
CR with incomplete hematologic recovery (CRi)
Time frame: 24 months
6 secondary outcomes
Relapse rate
Time frame: 24 months
Treatment-related mortality（TRM）
Time frame: 24 months
Overall Survival（OS）
Time frame: 24 months
Event-Free Survival（EFS）
Time frame: 24 months
Adverse Event
Time frame: 24 months
Mortality
Time frame: 24 months
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 10 Jul 2025.
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Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Induction Therapy Regimen, Pre-Treatment Regimen and Post-CR Treatment in people with Acute Lymphoblastic Leukemia, Adult, run by Shanxi Bethune Hospital at 1 site in China.
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 3 inclusion and 4 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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Tao Wang, Dr. (13835175119, wangtao99699@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2025.