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

NCT04679506 | Unknown

• 1 other identifier: CLAE
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Keywords

R/R T-ALL/LBL; CLAE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PFS

  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

  From the date of first study drug administration until the date of death due to any cause, assessed up to 24 months.

Interventions

Cladribine DRUG

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

Also known as: cytarabine, etoposide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A singe-arm of patients with R/R T-ALL/LBL

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cladribine; Cytarabine; Etoposide

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Hongmei Jing, MD, phD

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Hongmei Jing, MD, phD

CONTACT

15611908428; hongmeijing@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 22, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: December 22, 2020

Record last verified: 2020-12