CAV Regimen Bridging to HSCT for R/R AL | NCT05190549

NCT05190549

Protocol Section

Identification Module

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

Status Module

Name	Class
The Second People's Hospital of Huai'an	OTHER

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
CAV Regimen Bridging to HSCT	Experimental		Procedure: CAV regimen bridging to HSCT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAV regimen bridging to HSCT	Procedure	The enrolled patients will be firstly given CAV bridging regimen (cladribine 5mg/m2/ day for 5 days, cytarabine 20mg q12h for 10 days, and began at 100 mg on day 1 and increased stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, and 400 mg) on days 1-21. Conditioning regimen for allo-HSCT may be administrated after completion of the CAV regimen, with or without consolidation therapy.

Outcomes Module

Measure	Description	Time Frame
ORR (overall response rate)	ORR was calculated as the sum of CR, CRi, MLFS and PR.	1 month

Secondary Outcomes

Measure	Description	Time Frame
OS (Overall survival)	OS was defined as the time from enrollment to this study to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.	1 year
EFS (Event-free survival)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with AL must meet one of the following criteria ：A or B. A: relapsed AL disease was defined as follows: (1) Reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of >5% blasts in the bone marrow (BM) not attributable to another cause(e.g. regeneration after consolidation therapy); or (3) extramedullary relapse.

B: refractory AL disease was defined as follows: (1) failure to achieve CR, CRh or CRi after two courses of intensive induction treatment. or (2) failure to achieve complete remission after one cycle of induction chemotherapy or a reduction in the number of blasts of less than 50% after one cycle of induction treatment, with residual blasts >15%.
patients without ≥grade 3 of cardiac, hepatic, pulmonary, or renal dysfunctions.
sign informed consent voluntarily.
Patients aged between 16 and 70 years old, male or female is permitted.
ECOG performance status score less than 1.
The expected survival is longer than 3 months.

Exclusion Criteria:

With other malignant tumors.
Patients received the treatment of cladribine or venetoclax.
Patients received cardiac angioplasty or stent implantation.
Active infections that are not under clinical control (bacteria or fungus or virus is included).
Liver functions abnormalities (total bilirubin>1.5 times the upper limit of the normal range, ALT/AST>2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST>1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine>1.5 times the upper limit of normal value).
Pregnant or nursing women.
Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
Patients participated in any other clinical trials 3 months prior to signing the informed consent.
Patients not suitable for the study according to the investigator's assessment.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms