Health TrialsbyHealthPanel

VA as Maintenance Therapy Post Allo-HSCT in MDS and AML

ConditionAcute Myeloid Leukemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorNavy General Hospital, Beijing

About this trial

The goal of this phase 2 trial is to test the safety and efficacy of Venetoclax combined with Azacytidine as Maintenance Therapy post Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.

The patient is willing and able to adhere to the study visit schedule and other protocol requirements.

Patients aged ≥18 years with a diagnosis of MDS or AML according to World Health Organization criteria (WHO) who had undergone alloSCT with myeloablative or reduced-intensity conditioning regimens were eligible. Related and unrelated donors were permitted.

Patients should be in morphologic complete remission (CR; ie, ≤5% bone marrow blasts) with absolute neutrophil counts ≥1.0×10^9 /L and platelets ≥ 75×10^ 9 /L before treatment.

Disqualifiers

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.

Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.

Pregnant or lactating women.

Trial design

Design model

Single group

Treatments tested in this trial

  • Venetoclax combined with Azacytidine

    Drug

    Patients were treated by venetoclax and azacytidine: Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-7; Azacytidine 75 mg/m2 subcutaneous injection qd d1-5.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Venetoclax combined with AzacytidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relapse Rate

Relapse following CR is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.

Time frame
1 year

Secondary outcomes

1

Overall Survival (OS)

OS was defined as time from diagnosis to death from any cause or the last follow-up

Time frame
through study completion, an average of 2 years
2

Progression Free Survival (PFS)

For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Navy General Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

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