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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04679506
Collaborator
(none)
50
36

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. ORR [From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)]

    Objective response rate,sum of complete response rate and partial response rate

Secondary Outcome Measures

  1. 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.]

    progression-free survival

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

    overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Study Director: Hongmei Jing, MD, phD, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04679506
Other Study ID Numbers:
  • CLAE
First Posted:
Dec 22, 2020
Last Update Posted:
Dec 22, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2020