Azacitidine combined with CAG regimen in the treatment of relapsed or refractory T-cell lymphoma/acute T-lymphoblastic leukemia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000039465

Enrollment

Unknown

Registered

2020-10-28

Start date

2020-11-01

Completion date

Unknown

Last updated

2021-02-01

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

Conditions

relapsed or refractory T-cell lymphoma/acute T-lymphoblastic leukemia

Interventions

experimental group:azacitidine combined with CAG regimen

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients who had been diagnosed of T-cell acute lymphoblastic leukemia or T-cell lymphoma must be made before enrollment.Diagnostic criteria refer to WHO classification in 2016. 2.Refractory/Recurrence T-ALL: Refractory was defined as failure to achieve CR in course 1 of standard induced remission treatment (VDLP/VDCP/VDCLP); Recurrence was defined as > 5% of bone marrow original lymphocytes or the occurrence of extracellular leukemia in patients who had received CR in the past. 3.Relapse/Refractory T-cell lymphoma. 4.Patients aged 18-70 years. 5.Patients with physical fitness score of the Eastern Oncology Cooperative group 0~2. 6.Patients with creatinine clearance >= 30mL/min(assessed according to Cockcroft-Gault formula [Cockcroft et al 1976] or estimation of glomerular filtration rate [eGFR] from the nephrotic adjustment [MDRD] formula). 7.Patients with AST and ALT =50% (AHA 2016); 9.Patients with life expectancy > for 8 weeks.

Exclusion criteria

Exclusion criteria: 1.Patients with WBC > 50x10^9/L. 2.Patients who have received salvage treatment with CAG regimen. 3.Patients with clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional classification,or a history of myocardial infarction in the 6 months prior to screening. 4.Other serious diseases that may limit the patient's participation in this trial,such as advanced infections, uncontrolled diabetes.

Design outcomes

Primary

Measure	Time frame
ORR;Agranulocytosis time;Thrombocytopenia time;Incidence of infection;	—

Countries

China

Contacts

Public ContactPeng Hongling

The Second Xiangya Hospital, Central South University

penghongling@aliyun.com+86 13975806137

Outcome results

None listed

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