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PDT-ALL-2016 multi-center clinical study to accurately stratify and guide the overall program of targeted therapy for adult acute lymphoblastic leukemia

PDT-ALL-2016 Multi-center clinical study of precise stratification Guiding the overall regimen of targeted therapy for adult acute lymphoblastic leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084070
Enrollment
Unknown
Registered
2024-05-09
Start date
2018-02-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lymphocytic leukemia

Interventions

Philadelphia positive acute lymphoblastic leukemia subgroup:Targeted therapy is PD-1 antibody combined with conventional chemotherapy
Philadelphia-like (Ph-like) acute lymphoblastic leukemia :conventional chemotherapy
CD20 positive (> 20%) B precursor cells -ALL subgroup:conventional chemotherapy
Non-specific type B progenitor cell acute lymphoblastic leukemia subgroup:conventional chemotherapy
T-cell acute lymphoblastic leukemia:conventional chemotherapy
Mixed series acute leukemia MPAL subgroup:conventional chemotherapy

Sponsors

Department of Hematology, Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Age =14 years old, =55 years old, gender is not limited; 2. Newly diagnosed acute lymphoblastic leukemia, untreated; 3. At the same time meet the reserve function conditions of important organs: cardiac ultrasound LVEF=50%; TBIL = 1.5ULN; AST/ALT =2.5ULN; Serum creatinine level =1.5ULN; 4. The researchers assessed that the expected survival time was greater than 3 months; 5. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Burkitt lymphoma/leukemia; 2. Acute undifferentiated leukemia; 3. Pregnant women; 4. Severe uncontrolled active infection; 5. Patients with a history of pancreatitis; 6. Patients with severe diabetes who need to use insulin to control blood sugar; 7. Patients with a history of active gastrointestinal bleeding within the last 6 months; 8. History of arterial/venous thrombosis within the last 6 months; 9. In addition to leukemia, there are other tumors; 10. Patients with a history of allergy to any drug in the PDT-ALL-2016 regimen; 11. Other situations deemed unsuitable for this study by the investigator.

Design outcomes

Primary

MeasureTime frame
event-free survival;

Secondary

MeasureTime frame
minimal residual disease negative conversion rate;AEs;

Countries

China

Contacts

Public ContactLiu Qifa

Nanfang Hospital, Southern Medical University

liuqifa628@163.com+86 136 0279 1429

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026