Health TrialsbyHealthPanel

VA Induction and Bridging Transplantation for Hypoplastic/Secondary AML

ConditionsHypoplastic Acute Myeloid LeukemiaSecondary AML (Adult)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine（VA) induction followed by bridging allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the treatment of hypoplastic and secondary acute myeloid leukemia (AML).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Previously untreated acute myeloid leukemia (AML) diagnosed according to the 2022 ELN guidelines. Patients with isolated extramedullary disease (i.e., no evidence of AML in bone marrow or peripheral blood) are not eligible.

Bone marrow biopsy demonstrating cellularity <20% or concurrent myelofibrosis; Or a prior history of an antecedent hematologic disorder, radiotherapy/chemotherapy-related history, or presence of myelodysplasia-related changes (AML-MRC according to WHO-HEAM5).

The patient is deemed suitable for allogeneic hematopoietic stem cell transplantation as assessed by the treating physician.

Disqualifiers

Prior treatment for AML, except non-cytotoxic therapy given to stabilize disease.

White blood cell count ≥10×10⁹/L, or presence of proliferation-associated gene mutations such as FLT3.

Favorable risk group according to the 2022 ELN prognostic stratification, e.g., t(8;21), inv(16)/t(16;16), NPM1 mutation, or CEBPA bZIP in-frame mutation.

No suitable stem cell donor available.

Trial design

Design model

Single group

Treatments tested in this trial

  • Venetoclax (VEN)

    Drug

    Venetoclax was administered at 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-28 of cycle 1.

  • Azacitidine (AZA)

    Drug

    Azacitidine was administered at 75 mg/m² on days 1-7 of cycle 1.

  • Allo-HSCT

    Procedure/Surgery

    All patients proceeded directly to allogeneic HSCT after cycle 1, regardless of remission. Myeloablative or intensified conditioning was preferred; reduced-intensity conditioning was allowed for intolerant patients. Donor source and transplant type were not restricted.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: AExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time from the date of diagnosis to death due to any cause.

Time frame
2 year

Secondary outcomes

1

Complete Remission Rate（CRR）

Bone marrow blasts \<5%, absence of extramedullary disease, no circulating blasts, peripheral blood neutrophil count ≥1.0×10⁹/L, platelet count ≥100×10⁹/L, independent of transfusion or growth factor support.

Time frame
Day 28 of induction therapy and 56 days post-transplantation
2

Composite Complete Remission Rate (CCRR)

The proportion of patients achieving complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or complete remission with partial hematologic recovery (CRh).

Time frame
Day 28 of induction therapy and 56 days post-transplantation
3

Disease-free Survival (DFS)

Time from achieving disease remission to disease relapse or death from any cause.

Time frame
2 year
4

GVHD-free and Relapse-free Survival (GRFS)

Time from transplant date to the first occurrence of grade III-IV acute GVHD, chronic GVHD requiring systemic treatment, disease relapse, or death from any cause.

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Nanfang Hospital, Southern Medical University

Collaborator

Ruijin Hospital North Shanghai Jiao Tong University School of Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: