Patients With Recurrent Acute Myelogenous Leukemia After TransplantationNCT05266274
Clinical Efficacy and Safety of CD47 Monoclonal Antibody Combined With Azacitidine in the Treatment of Recurrent AML After Transplantation
A study testing CD47 monoclonal antibody in people with Patients With Recurrent Acute Myelogenous Leukemia After Transplantation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
After screening according to the criteria for selection and exclusion, patients who meet the criteria are selected, CD47 monoclonal antibody combined with azacitidine is used for the treatment of patients with recurrent AML after transplantation. The primary outcome is objective response rate (ORR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Recurrent Acute Myelogenous Leukemia After Transplantation
- What is being tested?
- CD47 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2021to 31 Dec 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old
- Diagnosis of AML and MDS recurrence after allogeneic hematopoietic stem cell transplantation according to WHO diagnostic criteria (flow MRD≥1%)
- ECOG rating 0-3
- Leukocyte ≤ 20×10^9/L (allowing hydroxyurea to lower leukocyte therapy); HB ≥ 70g/L, platelet ≥ 30×10^9/L (allow blood transfusion or supportive therapy such as erythropoietin/thrombopoietin, for those who have met all inclusion criteria but hemoglobin and/or platelet count are not fulfilled, discussion with the sponsor is required to determine the eligibility of the subject based on his/her risk and benefit)
- Liver function: total bilirubin ≦ 1.5 x ULN; alanine aminotransferase ≦ 3 x ULN; aspartate aminotransferase ≦ 3 x ULN; (except for leukemia infiltration)
- Renal function: endogenous creatinine clearance ≧60ml/min
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- the international normalized ratio ≤ 1.5, and the prothrombin time or activated partial thromboplastin time ≤ 1.5 × ULN
- Tolerate bone marrow puncture and undergo the test at the time point required by the program
- Patients who sign the informed consent form must have the ability to understand and be willing to participate in this study, and sign the informed consent form at the same time.
Who cannot join
- Active aGVHD.
- Patients with a history of myeloproliferative disorders (including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia) or with BCR-ABL1 translocation
- Concomitant central nervous system leukemia
- Previous history of chronic hemolytic anemia or Coomb test (+) during the screening period
- Patients who were allergic to azacytidine or CD47 inhibitors or experienced serious adverse reactions because of azacytidine or CD47 inhibitors
- Simultaneous participation in another interventional clinical study, except for: only participate in an observational (non-interventional) clinical study; in the survival follow-up phase of an interventional study
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- Glucocorticoids for therapeutic purposes have been used within 7 days prior to the first treatment. Nasal spraying, inhalational, topical glucocorticoids or low-dose intravenous glucocorticoids (i.e., no more than 10 mg/day prednisone or equivalent doses) are permitted. Prophylactic use of glucocorticoids is permitted to avoid allergic reactions from medical interventions (e.g., intravenous contrast gents, chemotherapeutic drugs, or blood transfusions)
- Live attenuated vaccines within 4 weeks prior to the first day of the study or planned for the treatment period, have undergone major surgical procedures (craniotomy, thoracic or open surgery) or are expected to receive major surgeries during the treatment period (except for PICC and deep vein catheterization)
- Patients who have non-hematologic toxicity caused by previous anti-leukemia treatment and the toxicity is not returned to NCI CTCAE v5.0 grade 0 to 1 (except for hair loss, fatigue), have uncontrolled active bleeding, coagulation disorders, or require therapeutic treatment with anticoagulants (such as warfarin, low molecular weight heparin, antiplatelet drugs, etc.)
- Presence of an active or suspected autoimmune disease or a history of the disease in recent 2 years (except for vitiligo, psoriasis, Hashimoto's thyroiditis or Grave's disease that do not require a systemic treatment within the last 2 years, hypothyroidism that only requires thyroid hormone replacement therapy, or type 1 diabetic subjects requiring only insulin therapy)
- A history of primary immunodeficiency
- A history of primary immunodeficiency
- Uncontrolled concurrent diseases include, but are not limited to:
- HIV infection (HIV antibody positive); Severe infections; Symptomatic congestive heart failure (New York Heart Association Grade II to IV) or poorly controlled arrhythmias that may pose a serious risk of cardiac arrest; Arterial hypertension (systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg) even with standardized treatment; Any arterial thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to enrollment; History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 6 months prior to enrollment; Any life-threatening bleeding events such as intracranial hemorrhage or grade 3 or 4 gastrointestinal/variceal bleeding events requiring transfusion, endoscopic or surgical treatment occurred within 6 months prior to enrollment; Subjects with evidence of portal hypertension or previous history of varicose vein bleeding; A history of gastrointestinal perforation and/or fistula within 6 months prior to enrollment.
- Uncontrolled metabolic disorders or other non-malignant systemic diseases that lead to a higher risk and/or uncertainty in survival evaluation.
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh grade B or more severe liver cirrhosis.
- History of intestinal obstruction or the following: inflammatory bowel disease or extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Other acute or chronic illnesses, psychiatric disorders, or abnormal laboratory test values that may result in poor adherence or increased risk associated with drug administration, or interference with the interpretation of study results, and who, based on investigator's judgment, are classified as ineligible for this study.
- Acute or chronic active hepatitis B or C infection: HbsAg and/or HbcAb positive and HBV DNA above the upper limit of normal, HBV DNA is not within the normal range after treatment, hepatitis C virus (HCV) antibody positive and RNA positive
- Patients with any kind of post-transplant complications: veno-occlusive disease (VOD), idiopathic pneumonia syndrome (IPS), septic shock, thrombotic microangiopathy (TMA)
- A history of other primary malignant tumors
- Patients with heart failure grade 2 or above
- Expected survival < 3 months
- Pregnant or lactating patients
- Refusal to enroll in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215000
Suning Chen, 13814881746, chensuning@sina.com
About this study
Official title: A Single-center, Single-arm Clinical Study of the Clinical Efficacy and Safety of CD47 Monoclonal Antibody Combined With Azacitidine in the Treatment of Recurrent AML After Transplantation
After screening according to the criteria for selection and exclusion, patients who meet the criteria are selected, CD47 monoclonal antibody combined with azacitidine is used for the treatment of patients with recurrent AML after transplantation. The primary outcome is objective response rate (ORR).
- Being tested
- CD47 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD47 monoclonal antibodyDrug
Also called azacitidine
patients who meet the criteria are selected, CD47 monoclonal antibody combined with azacitidine is used for the treatment of patients with recurrent AML after transplantation
| Study group | Role | What they receive |
|---|---|---|
| The Treatment of Recurrent AML After Transplantation | Experimental | Not described Receives: Drug: CD47 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Including complete response/complete response rate of incomplete hematologic recovery /partial response rate（CR/CRi/PR），after each course of treatment
Measured: about 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start14 Dec 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Recurrent Acute Myelogenous Leukemia After TransplantationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266274
- Sponsor's protocol ID
- CIBI188Y103
- Status last verified
- Dec 2021
- First submitted
- 17 Jan 2022
- Last updated
- 4 Mar 2022
- 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm Clinical Study of the Clinical Efficacy and Safety of CD47 Monoclonal Antibody Combined With Azacitidine in the Treatment of Recurrent AML After Transplantation
- ClinicalTrials.gov ID
- NCT05266274
- Acronym / sponsor ID
- CIBI188Y103
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Mar 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.
After screening according to the criteria for selection and exclusion, patients who meet the criteria are selected, CD47 monoclonal antibody combined with azacitidine is used for the treatment of patients with recurrent AML after transplantation. The primary outcome is objective response rate (ORR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Treatment of Recurrent AML After Transplantation | Experimental | Drug: CD47 monoclonal antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be at least 18 years old
- Diagnosis of AML and MDS recurrence after allogeneic hematopoietic stem cell transplantation according to WHO diagnostic criteria (flow MRD≥1%)
- ECOG rating 0-3
- Leukocyte ≤ 20×10^9/L (allowing hydroxyurea to lower leukocyte therapy); HB ≥ 70g/L, platelet ≥ 30×10^9/L (allow blood transfusion or supportive therapy such as erythropoietin/thrombopoietin, for those who have met all inclusion criteria but hemoglobin and/or platelet count are not fulfilled, discussion with the sponsor is required to determine the eligibility of the subject based on his/her risk and benefit)
- Liver function: total bilirubin ≦ 1.5 x ULN; alanine aminotransferase ≦ 3 x ULN; aspartate aminotransferase ≦ 3 x ULN; (except for leukemia infiltration)
Key exclusion criteria (25 listed)
- Active aGVHD.
- Patients with a history of myeloproliferative disorders (including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia) or with BCR-ABL1 translocation
- Concomitant central nervous system leukemia
- Previous history of chronic hemolytic anemia or Coomb test (+) during the screening period
- Patients who were allergic to azacytidine or CD47 inhibitors or experienced serious adverse reactions because of azacytidine or CD47 inhibitors
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 |
|---|---|---|
| CD47 monoclonal antibodyAlso: azacitidinepatients who meet the criteria are selected, CD47 monoclonal antibody combined with azacitidine is used for the treatment of patients with recurrent AML after transplantation | Drug | The Treatment of Recurrent AML After Transplantation |
Primary outcome
objective response rate
Time frame: about 3 months
Including complete response/complete response rate of incomplete hematologic recovery /partial response rate（CR/CRi/PR），after each course of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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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.
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD47 monoclonal antibody in people with Patients With Recurrent Acute Myelogenous Leukemia After Transplantation, 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 9 inclusion and 25 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 4 Mar 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: about 3 months). 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 4 Mar 2022.