the Efficacy and Safety of CLAE in R/R T-ALL/LBL | NCT04679506

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

NCT04679506

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Dec 22, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cladribine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2020Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Dec 13, 2020

First Submission Date that Met QC Criteria

Dec 17, 2020

First Posted Date

Dec 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2020

Last Update Posted Date

Dec 22, 2020Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Cladribine	Drug	CLAE regimen (cladribine + cytarabine + etoposide) for reinduction of R/R T-ALL/LBL		cytarabine etoposide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.
OS

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

ID	Term
D017338	Cladribine
D003561	Cytarabine
D005047	Etoposide

ID	Term
D015762	2-Chloroadenosine
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines