Clinical trial NCT04679506: the Efficacy and Safety of CLAE in R/R T-ALL/LBL
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Keywords: R/R T-ALL/LBL
CLAE
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A singe-arm of patients with R/R T-ALL/LBL

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: ORR
timeFrame: From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes:
measure: PFS
timeFrame: 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.
measure: OS
timeFrame: From the date of first study drug administration until the date of death due to any cause, assessed up to 24 months.
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Hongmei Jing, MD, phD
role: STUDY_DIRECTOR
References: