Acute Myeloid LeukemiaPhase 2NCT05330364
Study of Chidamide Combined With Cladribine in Refractory/Relapsed Acute Myeloid Leukemia
A Phase 2 study testing Chidamide and Cladribine in people with Acute Myeloid Leukemia, run by Ge Zheng at 1 site in China.
Trial summary
Acute myeloid leukemia (AML) is highly heterogeneous, the efficacy of the individual varies greatly, and the risk of recurrence is high. A large number of newly diagnosed AML patients cannot achieve complete remission (CR) after standard induction chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Chidamide and Cladribine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to Jun 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years old and less than 75 years old;
- Clinical diagnosis of Relapsed/Refractory AML (non-APL);
- ECOG performance status score 0-3;
- Participant has the ability to understand and willingness to sign a written consent document.
Who cannot join
- Pregnancy or nursing
- Uncontrolled significant cardiac disorder
- Psychiatric disorder may interfere with his / her compliance with the study protocol
- Known history of intolerance or allergy to any component of the research regimen
- Any condition not suitable for the trial as judged by the study investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University
Nanjing, Jiangsu, 210009
Zheng Ge, M.D, Ph.D, 02583262468, Janege879@hotmail.com
About this study
Official title: Clinical Study of Efficacy and Safety of Chidamide Combined With Cladribine Regimen in Refractory/Relapsed Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is highly heterogeneous, the efficacy of the individual varies greatly, and the risk of recurrence is high. A large number of newly diagnosed AML patients cannot achieve complete remission (CR) after standard induction chemotherapy. The prognosis of AML patients after relapse is extremely poor, and only a few patients can get remission through salvage treatment.
Chidamide is a histone deacetylase inhibitor (HDACi) independently developed by China. It has been marketed in recent years and the first innovative drug approved by the U.S. Food and Drug Administration for clinical research in the United States. Chidamide can increase the sensitivity of leukemia cells to conventional chemotherapy by inhibiting cell proliferation, inducing apoptosis, and increasing cell cycle arrest. Chidamide and other drugs have different effects in combination, and jointly bear the anti-tumor effect, which provides a theoretical basis for Chidamide in the treatment of acute myeloid leukemia.
Read more
Cladribine is a purine nucleoside analog, which has the ability to inhibit DNA synthesis, repair, induce apoptosis, and has anti-leukemia activity for cells in both mitotic and quiescent phases. In the past ten years, many studies have proved that Cladribine and its combination therapy are effective in patients with relapsed and refractory AML and de novo AML. The NCCN guidelines recommend the combination of cladribine as a category 1 recommendation for newly-diagnosed and refractory or relapsed adult AML. Several studies have confirmed the use of Cladribine in the treatment of refractory and relapsed AML.
The strong synergistic anti-cancer effect of HDACi combined with Cladribine has been shown in many cancers such as B-cell chronic lymphocytic leukemia, colon cancer, multiple myeloma, natural killer large granular lymphocytic leukemia, B-cell non-Hodgkin's lymphoma, and mantle cell lymphoma. Our previous study found a synergistic effect on combination of Chidamide and Cladribine in AML cell lines and primary cells. In clinical observation, refractory and relapsed AML patients also responded well to the combination of Chidamide plus Cladribine regimen. This provides a theoretical and practical basis for the use of the combination of Chidamide and Cladribine in AML patients.
Read the detailed description
This study is aimed to observe the efficacy and safety of the Chidamide Plus Cladribine regimen in treating patients with refractory or relapsed AML. Patients must provide written informed consent and meet all the inclusion criteria and none of the exclusion criteria to be eligible. The eligible patients with refractory or relapsed AML will receive chidamide plus cladribine regimen. Response criteria will be assessed according to the guidelines of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in AML. In case of partial remission, the second identical course will be started. In case of complete remission, allogeneic hematopoietic stem cell transplantation will be performed if available. Patients without complete remission after two courses of treatment will be withdrawn from the study.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Chidamide, Cladribine
- Keywords
- Acute Myeloid Leukemia, Chidamide, Cladribine
- 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.
ChidamideDrug
Chidamide 30mg/d p.o. begin at day 1, twice per week, during a 28-days cycle.
CladribineDrug
Cladribine 5mg/m2/d i.v. d1-5, once per day, during a 28-days cycle.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide plus Cladribine | Experimental | Chidamide 30mg/d per os (p.o.), twice per week, begins at day 1; Cladribine 5mg/m2/d, intravenous injection (i.v.), days 1-5, once per day; A cycle is during 28 days. Receives: Drug: Chidamide; Drug: Cladribine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission (CR) rate
Less than 5 percent of blast cells in bone marrow aspiration is defined as CR.
Measured: Bone marrow examination will be performed at the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (2)
Incidences of Adverse Events (AEs)
Safety and Tolerability
Measured: All AEs reported from the time of study drug administration until 30 days after discontinuation of study drug administration will be collected.
Overall Survival (OS)
The overall survival evaluation
Measured: OS is defined as the number of days from the date of the study enrollment to the date of death of any cause with a minimal 12 months of follow up. Subjects that have not died will be censored at the last known date to be alive.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Jun 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (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.
- 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ge Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ge Zheng, Zhongda Hospital
- Investigators
- Zheng Ge, M.D, Ph.D, Study director, Medicine School of South East University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330364
- Sponsor's protocol ID
- ZDYYGZ202103
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Efficacy and Safety of Chidamide Combined With Cladribine Regimen in Refractory/Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05330364
- Acronym / sponsor ID
- ZDYYGZ202103
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Chidamide, Cladribine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Ge ZhengUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Apr 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.
Acute myeloid leukemia (AML) is highly heterogeneous, the efficacy of the individual varies greatly, and the risk of recurrence is high. A large number of newly diagnosed AML patients cannot achieve complete remission (CR) after standard induction chemotherapy. The prognosis of AML patients after relapse is extremely poor, and only a few patients can get remission through salvage treatment.
Chidamide is a histone deacetylase inhibitor (HDACi) independently developed by China. It has been marketed in recent years and the first innovative drug approved by the U.S. Food and Drug Administration for clinical research in the United States. Chidamide can increase the sensitivity of leukemia cells to conventional chemotherapy by inhibiting cell proliferation, inducing apoptosis, and increasing cell cycle arrest. Chidamide and other drugs have different effects in combination, and jointly bear the anti-tumor effect, which provides a theoretical basis for Chidamide in the treatment of acute myeloid leukemia.
Cladribine is a purine nucleoside analog, which has the ability to inhibit DNA synthesis, repair, induce apoptosis, and has anti-leukemia activity for cells in both mitotic and quiescent phases. In the past ten years, many studies have proved that Cladribine and its combination therapy are effective in patients with relapsed and refractory AML and de novo AML. The NCCN guidelines recommend the combination of cladribine as a category 1 recommendation for newly-diagnosed and refractory or relapsed adult AML. Several studies have confirmed the use of Cladribine in the treatment of refractory and relapsed AML.
The strong synergistic anti-cancer effect of HDACi combined with Cladribine has been shown in many cancers such as B-cell chronic lymphocytic leukemia, colon cancer, multiple myeloma, natural killer large granular lymphocytic leukemia, B-cell non-Hodgkin's lymphoma, and mantle cell lymphoma. Our previous study found a synergistic effect on combination of Chidamide and Cladribine in AML cell lines and primary cells. In clinical observation, refractory and relapsed AML patients also responded well to the combination of Chidamide plus Cladribine regimen. This provides a theoretical and practical basis for the use of the combination of Chidamide and Cladribine in AML patients.
Detailed description
This study is aimed to observe the efficacy and safety of the Chidamide Plus Cladribine regimen in treating patients with refractory or relapsed AML. Patients must provide written informed consent and meet all the inclusion criteria and none of the exclusion criteria to be eligible. The eligible patients with refractory or relapsed AML will receive chidamide plus cladribine regimen. Response criteria will be assessed according to the guidelines of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in AML. In case of partial remission, the second identical course will be started. In case of complete remission, allogeneic hematopoietic stem cell transplantation will be performed if available. Patients without complete remission after two courses of treatment will be withdrawn from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide plus Cladribine | Experimental | Drug: Chidamide, Drug: CladribineChidamide 30mg/d per os (p.o.), twice per week, begins at day 1; Cladribine 5mg/m2/d, intravenous injection (i.v.), days 1-5, once per day; A cycle is during 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years old and less than 75 years old;
- Clinical diagnosis of Relapsed/Refractory AML (non-APL);
- ECOG performance status score 0-3;
- Participant has the ability to understand and willingness to sign a written consent document.
Key exclusion criteria (5 listed)
- Pregnancy or nursing
- Uncontrolled significant cardiac disorder
- Psychiatric disorder may interfere with his / her compliance with the study protocol
- Known history of intolerance or allergy to any component of the research regimen
- Any condition not suitable for the trial as judged by the study investigator.
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 |
|---|---|---|
| ChidamideChidamide 30mg/d p.o. begin at day 1, twice per week, during a 28-days cycle. | Drug | Chidamide plus Cladribine |
| CladribineCladribine 5mg/m2/d i.v. d1-5, once per day, during a 28-days cycle. | Drug | Chidamide plus Cladribine |
Primary outcome
Complete Remission (CR) rate
Time frame: Bone marrow examination will be performed at the end of Cycle 1 (each cycle is 28 days)
Less than 5 percent of blast cells in bone marrow aspiration is defined as CR.
2 secondary outcomes
Incidences of Adverse Events (AEs)
Time frame: All AEs reported from the time of study drug administration until 30 days after discontinuation of study drug administration will be collected.
Overall Survival (OS)
Time frame: OS is defined as the number of days from the date of the study enrollment to the date of death of any cause with a minimal 12 months of follow up. Subjects that have not died will be censored at the last known date to be alive.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Zheng Ge, M.D, Ph.D study director
Medicine School of South East University, China
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 Chidamide and Cladribine in people with Acute Myeloid Leukemia, run by Ge Zheng 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 4 inclusion and 5 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 29 Apr 2022. 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 Zheng Ge, M.D, Ph.D ((86)025-83262468, Janege879@hotmail.com), 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 examination will be performed at the end of Cycle 1 (each cycle is 28 days)). 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 29 Apr 2022.