the Efficacy and Safety of CLAE in R/R T-ALL/LBL

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL.

Detailed Description
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This study is a prospective, open, multiple -centered, sing-arm trial. The major aim of this studies to evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL. The study will include 50 subjects to receive CLAE regimen for reinduction chemotherapy.

Official Title
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Clinical Observation on the Efficacy and Safety of CLAE Regimen (Cladribine + Cytarabine + Etoposide) in the Treatment of Relapsed/Refractory T- Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

Conditions
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Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Intervention / Treatment
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* Drug: Cladribine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of T-acute lymphoblastic leukemia/lymphoblastic lymphoma according to World Health Organization (WHO) criteria which has relapsed or is refractory to chemotherapy. Age ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. The expected survival period is more than 12 weeks. At least one measurable nidus Adequate organ function defined as: Calculated creatinine clearance ≥ 50 ml/min using the cockcroft -Gault formula AST, ALT, total bilirubin ≤ 2 x upper limit of normal (ULN) except for Gilbert's disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia), in which case ALT and AST may be elevated up to ≤ 5 x ULN. Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document. Exclusion Criteria: Previous treatment with nelarabine or clofarabine or fludarabine or cladribine was ineffective. Pregnant or nursing. Received any other investigational agent or systemic cytotoxic chemotherapy within the preceding 2 weeks. Active HIV or hepatitis B or C infection. Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator's judgment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cladribine|CLAE regimen (cladribine + cytarabine + etoposide) for reinduction of R/R T-ALL/LBL|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate，sum of complete response rate and partial response rate | From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | From the date of first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. | 
| OS | overall survival | From the date of first study drug administration until the date of death due to any cause, assessed up to 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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R/R T-ALL/LBL, CLAE