Acute Leukemia, RelapsedPhase 2NCT05190549
CAV Regimen Bridging to HSCT for R/R AL
A Phase 2 study testing CAV regimen bridging to HSCT in people with Acute Leukemia, Relapsed and Acute Leukemia Refractory, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Acute Leukemia, Relapsed, Acute Leukemia Refractory
- What is being tested?
- CAV regimen bridging to HSCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 17 Nov 2024
- Phase
- Phase 2
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
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
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.
- Being tested
- CAV regimen bridging to HSCT
- Keywords
- CAV regimen, HSCT
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAV regimen bridging to HSCTProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CAV Regimen Bridging to HSCT | Experimental | Not described Receives: Procedure: CAV regimen bridging to HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (overall response rate)
ORR was calculated as the sum of CR, CRi, MLFS and PR.
Measured: 1 month
Secondary outcomes (3)
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.
Measured: 1 year
EFS (Event-free survival)
EFS was defined as the time from the initiation of CAV to treatment failure, relapse, death from any cause or the last follow-up.
Measured: 1 year
Adverse events (AEs)
It is evaluated and graded according to CTCAE 5.0.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Oct 2021
- Primary completion17 Nov 2024
- Study completion17 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Leukemia, RelapsedStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second People's Hospital of Huai'an
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
- Investigators
- Sheng-Li Xue, M.D., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190549
- Sponsor's protocol ID
- SZRRAL01
- Status last verified
- Nov 2024
- First submitted
- 4 Jan 2022
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05190549
- Acronym / sponsor ID
- SZRRAL01
- Keywords
- CAV regimen, HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- The Second People's Hospital of Huai'an
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 17 Nov 2024 (actual)
- Study completion
- 17 Nov 2024 (actual)
- First posted
- 13 Jan 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAV Regimen Bridging to HSCT | Experimental | Procedure: CAV regimen bridging to HSCT |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| CAV regimen bridging to HSCTThe 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. | Procedure or surgery | CAV Regimen Bridging to HSCT |
Primary outcome
ORR (overall response rate)
Time frame: 1 month
ORR was calculated as the sum of CR, CRi, MLFS and PR.
3 secondary outcomes
OS (Overall survival)
Time frame: 1 year
EFS (Event-free survival)
Time frame: 1 year
Adverse events (AEs)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
Sheng-Li Xue, M.D. principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAV regimen bridging to HSCT in people with Acute Leukemia, Relapsed and Acute Leukemia Refractory, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (overall response rate) (time frame: 1 month). 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 20 Nov 2024.