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

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04679506
• Other study ID #: CLAE
• Status: Not yet recruiting
• Start date: December 2020
• Est. completion date: December 2023

Study information

• Verified date: December 2020
• Source: Peking University Third Hospital
• Contact: Hongmei Jing, MD, phD
• Phone: 15611908428
• Email: hongmeijing[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.