Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2020-12-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Cladribine
CLAE regimen (cladribine + cytarabine + etoposide) for reinduction of R/R T-ALL/LBL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Hongmei Jing, MD, phD
Role: STUDY_DIRECTOR
Peking University Third Hospital
Central Contacts
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Other Identifiers
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CLAE
Identifier Type: -
Identifier Source: org_study_id