Clinical trial NCT05190549: CAV Regimen Bridging to HSCT for R/R AL
Official title: CAV Regimen (Cladribine Combined With Low Dose Ara-C and Venetoclax) Pretreatment Followed by Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Acute Leukemia: a Multi-center, Open-label and Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Leukemia, Relapsed
Acute Leukemia Refractory
Keywords: CAV regimen
HSCT
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: The Second People's Hospital of Huai'an
First posted: 2022-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although allogeneic hematopoietic stem cell transplantation (HSCT) is a curative treatment option for acute leukemia (AL), relapsed or refractory (R/R) AL is still a big challenge. It is believed that decreased tumor burden before HSCT is a favorable factor contributing to the long-term survival of R/R AL patients and many kinds of bridging chemotherapy regimens were devised to kill leukemic cells before HSCT, there is still no consensus that which regimen is optimal. This study is to investigate the curative efficacy and safety of bridging CAV (cladribine combined with low dose Ara-C and venetoclax) regimens followed by HSCT treatment protocol for R/R AML.


Eligibility criteria: Inclusion Criteria:

1. 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%.
2. patients without ≥grade 3 of cardiac, hepatic, pulmonary, or renal dysfunctions.
3. sign informed consent voluntarily.
4. Patients aged between 16 and 70 years old, male or female is permitted.
5. ECOG performance status score less than 1.
6. The expected survival is longer than 3 months.

Exclusion Criteria:

1. With other malignant tumors.
2. Patients received the treatment of cladribine or venetoclax.
3. Patients received cardiac angioplasty or stent implantation.
4. Active infections that are not under clinical control (bacteria or fungus or virus is included).
5. 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).
6. Pregnant or nursing women.
7. 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.
8. Patients participated in any other clinical trials 3 months prior to signing the informed consent.
9. Patients not suitable for the study according to the investigator's assessment.

Primary outcomes:
measure: ORR (overall response rate)
timeFrame: 1 month
Secondary outcomes:
measure: OS (Overall survival)
timeFrame: 1 year
measure: EFS (Event-free survival)
timeFrame: 1 year
measure: Adverse events (AEs)
timeFrame: 2 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Sheng-Li Xue, M.D.
role: PRINCIPAL_INVESTIGATOR
References: