Acute Myeloid LeukemiaPhase 2NCT03181815
Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia
A Phase 2 study testing Cladribine, G-CSF and Aclarubicin in people with Acute Myeloid Leukemia and Relapse Leukemia, run by Sun Yat-sen University at 1 site in China.
Trial summary
The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Relapse Leukemia
- What is being tested?
- Cladribine, G-CSF and Aclarubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2019
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women;
- Clinical diagnosis of Relapsed/Refractory AML (non-APL);
- ECOG performance status (PS) score 0-3;
- AST and ALT <=2.5 times the institutional ULN;
- Total bilirubin <=2.0 times the institutional ULN
- Serum creatinine<2.0 times the institutional ULN;
- Subjects should take effective contraceptive measures，and serum or urine pregnancy tests must be negative during the screening and study periods in women subjects;
- Patients should understand the disease and voluntarily receive the study regimen and follow-up.
Who cannot join
- Concurrent diagnosis of tumors other than AML, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN);
- Active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy;
- Concurrent autoimmune hemolytic anemia or immune thrombocytopenia;
- Subjects suffered from AIDS，active hepatitis B or C virus infection; 垫·Dementia or altered mental status that would prohibit the understanding or rendering of informed consent;
- Be allergic to any component of C-CAG regimen;
- Subjects ever exposed to cladribine or CAG-based regimen.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liang Wang
Guangzhou, Guangdong, 510060
Liang Wang, M.D., +862087342439, wangliang@sysucc.org.cn
About this study
Official title: Efficacy and Safety of Cladribine in Combination With G-CSF, Low-dose Cytarabine and Aclarubicin in Patients With Refractory/Relapsed Acute Myeloid Leukemia: a Phase 2 Clinical Trial
The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.
Read the detailed description
AML is most common in the elderly patients, who can not tolerate the intensified treatments. The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia, Relapse Leukemia
- Being tested
- Cladribine, G-CSF, Aclarubicin, Cytarabine
- Keywords
- CLADRIBINE, ACUTE MYELOID LEUKEMIA
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CladribineDrug
Also called cladribine injection
5mg/㎡ d1-5
G-CSFDrug
Also called granulocyte
300ug d0-9
AclarubicinDrug
Also called Aclacinomycin
10mg d3-6
CytarabineDrug
Also called Ara-C
10mg/㎡ q12h SC d3-9
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | The patients in this arm will receive C-CAG regimen for salvage treatment,detailed as following: Cladribine 5mg/㎡，d1-5；G-CSF 300ug,d0-9; aclarubicin 10mg,d3-6;cytarabine 10mg/㎡ q12h, SC, d3-9;4 weeks a cycle Receives: Drug: Cladribine; Drug: G-CSF; Drug: Aclarubicin; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission (CR) rate
Less than 5% of blast cells in bone marrow aspiration is defined as CR.
Measured: Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment)
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The hematologic toxicities and non-hematologic toxicities will be graded according to CTCAE version 3.0
Measured: From initiation of C-CAG treatment to end of the study (about within 3 months since enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Wang, Sun Yat-sen University
- Investigators
- Liang Wang, M.D., Principal investigator, Sun Yat-sen Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181815
- Sponsor's protocol ID
- C-CAG in AML
- Status last verified
- Aug 2019
- First submitted
- 7 Jun 2017
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cladribine in Combination With G-CSF, Low-dose Cytarabine and Aclarubicin in Patients With Refractory/Relapsed Acute Myeloid Leukemia: a Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT03181815
- Acronym / sponsor ID
- C-CAG in AML
- Conditions
- Acute Myeloid Leukemia, Relapse Leukemia
- Keywords
- CLADRIBINE, ACUTE MYELOID LEUKEMIA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 9 Jun 2017 (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.
The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.
Detailed description
AML is most common in the elderly patients, who can not tolerate the intensified treatments. The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Cladribine, Drug: G-CSF, Drug: Aclarubicin, Drug: CytarabineThe patients in this arm will receive C-CAG regimen for salvage treatment,detailed as following: Cladribine 5mg/㎡，d1-5；G-CSF 300ug,d0-9; aclarubicin 10mg,d3-6;cytarabine 10mg/㎡ q12h, SC, d3-9;4 weeks a cycle |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women;
- Clinical diagnosis of Relapsed/Refractory AML (non-APL);
- ECOG performance status (PS) score 0-3;
- AST and ALT <=2.5 times the institutional ULN;
- Total bilirubin <=2.0 times the institutional ULN
Key exclusion criteria (6 listed)
- Concurrent diagnosis of tumors other than AML, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN);
- Active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy;
- Concurrent autoimmune hemolytic anemia or immune thrombocytopenia;
- Subjects suffered from AIDS，active hepatitis B or C virus infection; 垫·Dementia or altered mental status that would prohibit the understanding or rendering of informed consent;
- Be allergic to any component of C-CAG regimen;
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 |
|---|---|---|
| CladribineAlso: cladribine injection5mg/㎡ d1-5 | Drug | treatment arm |
| G-CSFAlso: granulocyte300ug d0-9 | Drug | treatment arm |
| AclarubicinAlso: Aclacinomycin10mg d3-6 | Drug | treatment arm |
| CytarabineAlso: Ara-C10mg/㎡ q12h SC d3-9 | Drug | treatment arm |
Primary outcome
Complete Remission (CR) rate
Time frame: Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment)
Less than 5% of blast cells in bone marrow aspiration is defined as CR.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From initiation of C-CAG treatment to end of the study (about within 3 months since enrollment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Liang Wang, M.D. principal investigator
Sun Yat-sen Univerisity
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 Cladribine, G-CSF and Aclarubicin in people with Acute Myeloid Leukemia and Relapse Leukemia, run by Sun Yat-sen 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Wang, M.D. (+862087342439, wangliang@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission (CR) rate (time frame: Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment)). 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 Aug 2019.