Precursor T-Cell Lymphoblastic Leukemia-LymphomaNCT04679506
the Efficacy and Safety of CLAE in R/R T-ALL/LBL
An observational study of Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, run by Peking University Third Hospital.
Trial summary
To evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
- What is being tested?
- Cladribine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A singe-arm of patients with R/R T-ALL/LBL
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
To evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL.
Read the 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.
- Being tested
- Cladribine
- Keywords
- R/R T-ALL/LBL, CLAE
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CladribineDrug
Also called cytarabine, etoposide
CLAE regimen (cladribine + cytarabine + etoposide) for reinduction of R/R T-ALL/LBL
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate，sum of complete response rate and partial response rate
Measured: From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes (2)
PFS
progression-free survival
Measured: 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
overall survival
Measured: From the date of first study drug administration until the date of death due to any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precursor T-Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongmei Jing, MD, phD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679506
- Sponsor's protocol ID
- CLAE
- Status last verified
- Dec 2020
- First submitted
- 13 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04679506
- Acronym / sponsor ID
- CLAE
- Keywords
- R/R T-ALL/LBL, CLAE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A singe-arm of patients with R/R T-ALL/LBL
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CladribineAlso: cytarabine, etoposideCLAE regimen (cladribine + cytarabine + etoposide) for reinduction of R/R T-ALL/LBL | Drug | – |
Primary outcome
ORR
Time frame: 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
2 secondary outcomes
PFS
Time frame: 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
Time frame: From the date of first study drug administration until the date of death due to any cause, assessed up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongmei Jing, MD, phD study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongmei Jing, MD, phD (15611908428, hongmeijing@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.