NCT05190549CompletedPhase 2
CAV Regimen Bridging to HSCT for R/R AL
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
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 4 Jan 2022
- Start date
- 1 Oct 2021
- Primary completion date
- 17 Nov 2024
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Childhood cancers
- NCT number
- NCT05190549
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 1 Oct 2021 to the primary completion date, 17 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients received the treatment of cladribine or venetoclax.
- Patients received cardiac angioplasty or stent implantation.
- Patients participated in any other clinical trials 3 months prior to signing the informed consent.
Other illness
- With other malignant tumors.
- Active infections that are not under clinical control (bacteria or fungus or virus is included).
- 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.
Lab values
- 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).
Other
- Pregnant or nursing women.
- Patients not suitable for the study according to the investigator's assessment.
Who the study is looking for
- 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.
Age in the registry: 16 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.