CVA Regimen Bridging to HSCT for R/R AL
Study Details
Study Description
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 favourable factor contributing to the long-term survival of R/R 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 safty of bridging CAV (cladribine combined with venetoclax and low dose Ara-C ) regimens followed by HSCT treatment proctocal for R/R AML.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CVA Regimen Bridging to HSCT
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Drug: CVA regimen bridging to HSCT
The enrolled patients will be first given CVA bridging regimen(cladribine 5mg/m2/ day for 3 days, vinetoclax 400mg/ day for 7 days, and cytarabine 20mg q12h for 7 days). Then, preconditioning regimen will be admistrated, and allogeneic hematopoietic stem cell transplantation would be performed 2 days after the end of preconditioning regimen.
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Outcome Measures
Primary Outcome Measures
- overall survival [1 year]
It's measued from the time of entrying into this trial to the date of death from any cause,patients not known to have died at least follow-up are censored on the date they were last known to be alive.
- leukemia free survival [1 year]
It's measured from the date of complete remission to the date of relapse.
Secondary Outcome Measures
- complete remission rate [30 days after infusion of hematopoietic stem cells.]
Complete remission rate achived after finishing HSCT.
- relapse [1 year]
The relapsed AML was defined according to the following criteria: leukemic cells reappeared in peripheral blood, or the percentage of bone marrow blasts exceeded 5% or the accurrence of extra-medullary infiltration of leukemia.
- non relapse mortality [1 year]
NRM were described using cumulative incidence, with relapse as the competing event for NRM .
- graft versus host disease [1 year]
GVHD were graded after finishing the transplantation according to 1994 Consensus Conferences on acute GVHD grading and NIH criteria on chronic CVHD grading.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with AL must meet one of the following criteria ：A or B. A: relapse AL desease was defined as followes:(Reappearance of leukemic blasts in the pheripheral 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 attained CR following exposure to at least 2 courses of standed or intensive induction therapy,or(2)bone marrow leukemia cell decline index (BMCDI)<50% and>15% blast existence after one course of standed or intensive induction therapy.
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patients without serious disease of heart or liver or lung or renals.
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sign informed consent voluntarily.
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Patients aged between 18 and 65 years old,male or female is permitted.
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ECOG performence status score less than 1.
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The expected survival is longer than 3 months.
Exclusion Criteria:
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With other malignant tumors.
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Patients received the treatment of cladribine or venetoclax.
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Patients received cardiac angioplasty or stent implantation or h
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Active infections that are not under clinical control(bacteria or fungus or virus is included).
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Liver functions abnormilities (total bilirubin>1.5 times the upper limit of the 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).
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Pregnant or nursing women.
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Patieents 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.
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Patients participated in any other clinical trials 3 months prior to signing the informed consent.
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Patients not suitable for the study according to the investigator's assessment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215006 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
- The Second People's Hospital of Huai'an
Investigators
- Principal Investigator: Sheng-Li Xue, M.D., The First Affiliated Hospital of Soochow University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SZRRAL01