Acute Myeloid LeukemiaPhase 1/2NCT03913312
Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With AML
A Phase 1/2 study testing Unrelated cord blood in people with Acute Myeloid Leukemia, run by Ruijin Hospital at 1 site in China.
Trial summary
Acute myeloid leukemia (AML) is a clonal disease caused by genetic mutations in Hematopoietic stem progenitor cells. Unfortunately, advanced age (>60 years old) is considered to be one of the most important adverse prognostic factors for AML, and older patients are unable to tolerate high-dose chemotherapy, due to… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Unrelated cord blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Sep 2022
- Phase
- Phase 1/2
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML patients diagnosed by bone marrow morphology and Immunology;
- Exclusion of APL by Bone marrow morphology or molecular level;
- A patient who has obtained bone marrow cytology remission after inductive treatment;
- Aged from 60 to 75 years;
- Liver and kidney function: blood bilirubin ≤ 35μmol / L, AST or/ALT <2 times the upper limit of normal (ULN), serum creatinine;≤ 150μmol / L;
- The function of Heart is normal;
- Physical condition score 0-2 (ECOG score);
- Get informed consent signed by patient or family member.
Who cannot join
- APL patients, treatment-related AML;
- Retreatment of patients;
- Allergies to any of the drugs involved in the protocol;
- There are obvious contraindications to chemotherapy drugs;
- Liver and kidney function is obviously abnormal, exceeding the inclusion criteria;
- Serious heart disease, including myocardial infarction, cardiac insufficiency;
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- Suffering from other organ malignant tumors at the same time ;
- Active period of tuberculosis patients and HIV-positive patients;
- Suffering from other blood system diseases at the same time;
- Pregnancy or breastfeeding;
- Cannot understand or follow the research plan;
- A history of intolerance or allergies to similar drugs;
- Patients under 60 years of age or over 75 years of age;
- Participate in other clinical researchers at the same time;
- There are other situations that hinder the conduct of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Junmin Li, M.D., drlijunmin@126.com
About this study
Official title: Multicenter, One-arm, Phase II Clinical Study of Decitabine Combined With Unrelated Cord Blood Transplantation for the Treatment of Acute Myeloid Leukemia (AML) in the Elderly
Acute myeloid leukemia (AML) is a clonal disease caused by genetic mutations in Hematopoietic stem progenitor cells. Unfortunately, advanced age (>60 years old) is considered to be one of the most important adverse prognostic factors for AML, and older patients are unable to tolerate high-dose chemotherapy, due to various complications and organ dysfunction. Based on the results of the previous research, we will carry out the pretreatment regimen of decitabine + cytarabine in elderly patients with AML who have achieved disease treatment through induction therapy, and continue the transplantation program of unrelated-blood cord blood. By assessing the patient's DFS,OS,RFS and safety to determine whether the regimen is suitable for the consolidation treatment of elderly acute myeloid leukemia, further clarify the efficacy of this regimen compared with traditional consolidation therapy, and initially confirm the effect of combined with unrelated cord blood transplantation in the treatment of acute myeloid leukemia.
Read the detailed description
A prospective,Multicenter,open,single-arm clinical study.The research process is divided into three phases: the screening phase, the treatment phase, and the follow-up phase. The treatment phase includes pre-transplant pretreatment, cord blood transplantation, and consolidation therapy.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Unrelated cord blood
- Keywords
- AML,Elderly patients,Decitabine,Unrelated cord blood
- 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.
Unrelated cord bloodBiological
Unrelated cord blood comes from Shandong cord blood bank. TNC>1.5*107/kg;HLA 4-5/6
| Study group | Role | What they receive |
|---|---|---|
| DAC combined with unrelated cord blood transplantation | Experimental | Decitabine (DAC) 15mg/m2/d, d-7 to d-3;Ara-C 1000g/m2/q12h, d-2 to d-1.Single unrelated cord blood (TNC>1.5*107/kg), d0. Receives: Biological: Unrelated cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
Measured: Three years
Secondary outcomes (3)
Overall Survival (OS)
The time from enrollment to death for any reason
Measured: Three years
Complete Remission Rate (CR)
The proportion of cases of hematologic remission that reached the total
Measured: Three years
Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03).
Safety/Toxicity Monitoring
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start1 Sep 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Sep 2022 (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 Ruijin HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Navy General Hospital, Beijing, Beijing Jishuitan Hospital, The Affiliated Hospital of Xuzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Luoyang Central Hospital, People's Hospital of Zhengzhou University, Dongguan People's Hospital, The First Affiliated Hospital of Xiamen University, Taian City Central Hospital, Qilu Hospital of Shandong University (Qingdao)
- Responsible party
- Principal investigator, Li Junmin, Ruijin Hospital
- Investigators
- Junmin Li, Principal investigator, Ruijin Hospital Affiliated to Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913312
- Sponsor's protocol ID
- RJ-AML 2018
- Status last verified
- Jul 2019
- First submitted
- 11 Apr 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, One-arm, Phase II Clinical Study of Decitabine Combined With Unrelated Cord Blood Transplantation for the Treatment of Acute Myeloid Leukemia (AML) in the Elderly
- ClinicalTrials.gov ID
- NCT03913312
- Acronym / sponsor ID
- RJ-AML 2018
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML,Elderly patients,Decitabine,Unrelated cord blood
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Navy General Hospital, Beijing, Beijing Jishuitan Hospital, The Affiliated Hospital of Xuzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Luoyang Central Hospital, People's Hospital of Zhengzhou University, Dongguan People's Hospital, The First Affiliated Hospital of Xiamen University, Taian City Central Hospital, Qilu Hospital of Shandong University (Qingdao)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 12 Apr 2019 (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 a clonal disease caused by genetic mutations in Hematopoietic stem progenitor cells. Unfortunately, advanced age (>60 years old) is considered to be one of the most important adverse prognostic factors for AML, and older patients are unable to tolerate high-dose chemotherapy, due to various complications and organ dysfunction. Based on the results of the previous research, we will carry out the pretreatment regimen of decitabine + cytarabine in elderly patients with AML who have achieved disease treatment through induction therapy, and continue the transplantation program of unrelated-blood cord blood. By assessing the patient's DFS,OS,RFS and safety to determine whether the regimen is suitable for the consolidation treatment of elderly acute myeloid leukemia, further clarify the efficacy of this regimen compared with traditional consolidation therapy, and initially confirm the effect of combined with unrelated cord blood transplantation in the treatment of acute myeloid leukemia.
Detailed description
A prospective,Multicenter,open,single-arm clinical study.The research process is divided into three phases: the screening phase, the treatment phase, and the follow-up phase. The treatment phase includes pre-transplant pretreatment, cord blood transplantation, and consolidation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAC combined with unrelated cord blood transplantation | Experimental | Biological: Unrelated cord bloodDecitabine (DAC) 15mg/m2/d, d-7 to d-3;Ara-C 1000g/m2/q12h, d-2 to d-1.Single unrelated cord blood (TNC>1.5*107/kg), d0. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- AML patients diagnosed by bone marrow morphology and Immunology;
- Exclusion of APL by Bone marrow morphology or molecular level;
- A patient who has obtained bone marrow cytology remission after inductive treatment;
- Aged from 60 to 75 years;
- Liver and kidney function: blood bilirubin ≤ 35μmol / L, AST or/ALT <2 times the upper limit of normal (ULN), serum creatinine;≤ 150μmol / L;
Key exclusion criteria (15 listed)
- APL patients, treatment-related AML;
- Retreatment of patients;
- Allergies to any of the drugs involved in the protocol;
- There are obvious contraindications to chemotherapy drugs;
- Liver and kidney function is obviously abnormal, exceeding the inclusion criteria;
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 |
|---|---|---|
| Unrelated cord bloodUnrelated cord blood comes from Shandong cord blood bank. TNC>1.5*107/kg;HLA 4-5/6 | Biological | DAC combined with unrelated cord blood transplantation |
Primary outcome
Disease free survival (DFS)
Time frame: Three years
3 secondary outcomes
Overall Survival (OS)
Time frame: Three years
Complete Remission Rate (CR)
Time frame: Three years
Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03).
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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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.
Junmin Li principal investigator
Ruijin Hospital Affiliated to Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Unrelated cord blood in people with Acute Myeloid Leukemia, run by Ruijin Hospital 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 15 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 23 Jul 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Junmin Li (86-21-64374756, drlijunmin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: Three years). 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 23 Jul 2019.