A prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of CAG regimen for relapse/refractory T-acute lymphocytic leukemia/T-lymphoblastic lymphoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900023581

Enrollment

Unknown

Registered

2019-06-02

Start date

2019-06-01

Completion date

Unknown

Last updated

2019-06-03

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

Conditions

T-acute lymphocytic leukemia/ T-lymphoblastic lymphoma

Interventions

Case series:CAG regimen

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. T cell acute lymphoblastic leukemia/T lymphoblastic lymphoma must be diagnosed before enrollment. The diagnostic criteria refer to the 2016 WHO classification; 2. Definitions of relapse/refractory T-acute lymphocytic leukemia/T-lymphoblastic lymphoma: refractory was defined as standard induced remission therapy (VDLP/VDCP/VDCLP) did not reach CR in 1 course of treatment; relapse was defined as having >5% of bone marrow primordial lymphocytes in patients with CR Outer leukemia; 3. Aged 18-70 years old; 4. The Eastern Oncology Cooperative Group (ECOG) scores 0 to 2 (see Appendix 1). 5. Creatinine clearance = 30 mL/min (evaluated according to Cockcroft-Gault formula [Cockcroft et al 1976] or estimated glomerular filtration rate [eGFR] from the kidney disease adjustment [MDRD] formula); 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 × upper limit of normal range (ULN), total bilirubin = 2 × ULN; 7. Echocardiography (ECHO) shows a left ventricular ejection fraction (LVEF) = 50% (AHA 2016); 8. Life expectancy > 8 weeks; 9. Informed consent can be provided to understand and comply with the research requirements.

Exclusion criteria

Exclusion criteria: 1. WBC>50×10^9/L; 2. Patients who have received salvage treatment with the CAG program; 3. Currently active clinical cardiovascular disease, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, according to the New York Heart Association (NYHA) functional grading (see Appendix 2) Any grade 3 or 4 heart disease, or a history of myocardial infarction within 6 months prior to screening; 4. Other serious diseases that may limit the patient's participation in this trial (eg, advanced infection, uncontrolled diabetes).

Design outcomes

Primary

Measure	Time frame
The rate of one-cycle CR/CRi;	—

Secondary

Measure	Time frame
Safety;MRD;Medical cost;	—

Countries

China

Contacts

Public ContactJie Jin

The First Affiliated Hospital, College of Medicine, Zhejiang University

jiej0503@163.com+86 13505716779

Outcome results

None listed

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