AML (Acute Myelogenous Leukemia)Phase 2NCT06783790
Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT
A Phase 2 study testing Avapritinib, azacitidine, Venetoclax in people with AML (Acute Myelogenous Leukemia), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a single-center, prospective, single-arm, exploratory clinical study. To explore the efficacy and safety of avapritinib in patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation with C-KIT mutation RUNX1::RUNX1T1 or CBFB::MYH11. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML (Acute Myelogenous Leukemia)
- What is being tested?
- Avapritinib, azacitidine, Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to Dec 2027
- Phase
- Phase 2
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
- Subjects met the criteria for recurrence after allogeneic transplantation: re-emergence of leukemia cells or bone marrow original cells in peripheral blood >5% (except for other causes such as bone marrow recovery period) or extramedullary leukemia cell infiltration or molecular or cytogenetic recurrence.
- Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations
- Patients with CBFB::MYH11 gene or RUNX1::RUNX1T1 fusion gene detected.
- Eastern Cancer Collaboration Group (ECOG) physical status score 0-2 points.
- Liver, kidney and cardiopulmonary functions met the following requirements: Within 2 weeks before enrollment ① creatinine ≤1.5 upper limit of normal value; ② Left ventricular ejection fraction ≥50%; ③ Blood oxygen saturation >91%; ④ Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; Myocardial enzymes < 2 times the upper limit of normal (for the same age)
- Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.
Who cannot join
- Known allergy to KIT inhibitor drug analogues.
- Patients who have received previous treatment with Midostaurin.
- Patients who have previously been treated with mutation-specific C-KIT inhibitors and have developed disease progression during treatment.
- FLT3-ITD mutation in patients with recurrent/refractory disease (except low gene ratio).
- HIV infected persons, HBV, HCV active infected persons.
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
- With uncontrolled active GVHD (NIH for GVHD diagnosis and classification standards, aGVHD classification refer to the improved Glucksberg standard).
- Central nervous system leukemia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin
Erlie Jiang, +86-15122538106, jiangerlie@ihcams.ac.cn
About this study
Official title: An Exploratory Clinical Study of the Safety and Efficacy of Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
This is a single-center, prospective, single-arm, exploratory clinical study. To explore the efficacy and safety of avapritinib in patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation with C-KIT mutation RUNX1::RUNX1T1 or CBFB::MYH11.
Read the detailed description
We enrolled 20 patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation of RUNX1::RUNX1T1 or CBFB::MYH11 with C-KIT mutation.
The study was divided into induction therapy period and consolidation therapy period, and the study design was as follows:
A: Induction therapy period: After patients were screened and enrolled, they began to receive 1-2 cycles of induction therapy, and the specific administration regimen was as follows: Avapritinib 100mg po qd D1-D14, azacitidine 35mg/m2 ih D1-D5, Venetoclax 100mg po qd D1-D14. The 28-day cycle was followed by curative effect evaluation at the end of each cycle. Patients who achieved complete remission entered the consolidation treatment stage.
B: Consolidation therapy period: Patients who achieved complete remission after 1-2 cycles of induction therapy continued to receive avapritinib 100mg/d po. monotherapy for consolidation therapy, with a cycle of 28 days and a total of 4 cycles.
- Conditions
- AML (Acute Myelogenous Leukemia)
- Being tested
- Avapritinib, azacitidine, Venetoclax
- 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.
Avapritinib, azacitidine, VenetoclaxDrug
A: Induction therapy period: After patients were screened and enrolled, they began to receive 1-2 cycles of induction therapy, and the specific administration regimen was as follows: Avapritinib 100mg po qd D1-D14, azacitidine 35mg/m2 ih D1-D5, Venetoclax 100mg po qd D1-D14. The 28-day cycle was followed by curative effect evaluation at the end of each cycle. Patients who achieved complete remission entered the consolidation treatment stage.
B: Consolidation therapy period: Patients who achieved complete remission after 1-2 cycles of induction therapy continued to receive avapritinib 100mg/d po. monotherapy for consolidation therapy, with a cycle of 28 days and a total of 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Avapritinib combined with Azacitidine and Venetoclax Receives: Drug: Avapritinib, azacitidine, Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-month ORR after induction therapy
2-month objective remission rate after induction therapy
Measured: 2 months after induction therapy
Secondary outcomes (4)
CR rate after induction therapy
CR rate after 2 months
Measured: 2 months after induction therapy
MRD negative rate after induction therapy
MRD negative rate after 2 months
Measured: 2 months after induction therapy
Response rate after Consolidation treatment
Response rate after 6 months
Measured: 6 months after Consolidation treatment
Safety
Types of adverse events (AE), AE severity, Relevance to study drugs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myelogenous Leukemia)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erlie Jiang, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783790
- Sponsor's protocol ID
- IIT2024097
- Status last verified
- Dec 2024
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No