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Trial Title:
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
NCT ID:
NCT06634394
Condition:
Acute Myeloid Leukemia (AML)
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Conditions: Keywords:
Acute Myeloid Leukemia
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
APVO436
Description:
Infusion drug administered as a 4 hour infusion.
Arm group label:
Treatment Arm APVO436 in combination with Venetoclax and Azacitidine
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Oral tablet given on days 1 through 22, of a 28 day cycle.
Arm group label:
Treatment Arm APVO436 in combination with Venetoclax and Azacitidine
Other name:
venclexta
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Intravenous infusion given on days 1-8 of a 28 day cycle
Arm group label:
Treatment Arm APVO436 in combination with Venetoclax and Azacitidine
Other name:
vidaza
Summary:
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in
combination with venetoclax and azacitidine (ven/aza) in adult patients with newly
diagnosed, CD123+ AML.
Detailed description:
Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. In Cycle 1
(C1) only, to reduce the risk of CRS, each cohort will receive 4 priming doses of APVO436
respectively. APVO436 will be given in combination with venetoclax and azacitidine. For
C1D15 and all doses in each subsequent cycle, cohorts will receive APVO436 at the
determined cohort dose level.
APVO436 dosing will be administered by a 4-hour intravenous (IV) infusion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World
Health Organization (WHO) criteria and not been previously treated.
3. Patients must have CD123-positive AML as confirmed by local flow cytometry (or
immunohistochemistry [IHC]). Confirmation at diagnosis is acceptable.
4. Patient must be considered ineligible for induction therapy defined by at least
one of the following:
1. ≥75 years of age
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3
3. Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection
fraction ≤ 50%, or chronic stable angina)
4. Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%)
5. Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet
in Renal Disease (MDRD) formular
6. Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5.
Patient must have a projected life expectancy of ≥12 weeks
Exclusion Criteria:
1. Patient has received treatment with the following:
1. A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML,
myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or
myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
2. CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant
(HSCT)
3. Experimental therapies for MDS or AML
2. Patient is currently participating in another interventional research study.
3. Patient has history of MPN including myelofibrosis, essential thrombocythemia,
polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1
translocation, or AML with BCR-ABL1 translocation.
4. Patient has acute promyelocytic leukemia.
5. Patient has a current autoimmune disorder requiring immunosuppressive therapy such
as systemic (oral or IV) steroid therapy >10 mg methylprednisolone daily or its
equivalent
6. Patient is receiving concurrent corticosteroid therapy as an anticancer drug (any
dose).
7. Patient has known active CNS involvement with AML. Patients who received intrathecal
chemotherapy for prophylaxis of AML in the CNS prior to enrollment may enroll in
this study.
8. Creatinine clearance <30ml/min based on Cockcroft-Gault or MDRD formular.
9. Bilirubin of >3xULN in the absence of Gilbert's Syndrome.
10. AST and/or ALT >3 times the ULN.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
March 2028
Lead sponsor:
Agency:
Aptevo Therapeutics
Agency class:
Industry
Source:
Aptevo Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06634394
