Clinical Efficacy and Safety of CD47 Monoclonal Antibody Combined With Azacitidine in the Treatment of Recurrent AML After Transplantation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    69
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 15 March 2022

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).

Details
Condition Patients With Recurrent Acute Myelogenous Leukemia After Transplantation
Treatment CD47 monoclonal antibody
Clinical Study IdentifierNCT05266274
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note