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VEN+DAC+Bu2Flu4 vs Bu2Flu5 Conditioning Regimen for Elderly Myeloid Malignancies Undergoing Allo-HSCT

ConditionsOlder PatientsMyeloid MalignanciesConditioningHematopoietic Stem Cell Transplantation (HSCT)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age60-75
SponsorNanfang Hospital, Southern Medical University

About this trial

The purpose of this study is to compare the efficacy and safety of venetoclax+decitabine+busulfan+fludarabine (VEN+DAC+Bu2Flu4) regimen with busulfan+fludarabine (Bu2Flu5) regimen in older patients with myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

60-75 years

Acute myeloid leukaemia in first complete remission or myelodysplastic syndrome

Willing to undergo the first allo-HSCT

Eastern Cooperative Oncology Group performance status of 0-2

Disqualifiers

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)

Patients with any conditions not suitable for the trial (investigators' decision)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Venetoclax (VEN)

    Drug

    Venetoclax (VEN) was administered at 400mg/day on days -10 to -4.

  • Decitabine (DAC)

    Drug

    Decitabine (DAC) was administered at 20mg/m2/day on days -10 to -8.

  • Busulfan (Bu)

    Drug

    Busulfan (Bu) was administered at 3.2 mg/kg/day on days -5 to -4.

  • Fludarabine (Flu)

    Drug

    Fludarabine (Flu) was administered at 30mg/m2/day on days -5 to -2.

  • Fludarabine (Flu)

    Drug

    Fludarabine (Flu) was administered at 30mg/m2/day on days -6 to -2.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: VEN+DAC+Bu2Flu4Experimental treatment 4 interventions
Group B: Bu2Flu5Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Disease-free survival (DFS) rate

Will calculate time from random assignment until disease progression or relapse or death from any cause

Time frame
2 year

Secondary outcomes

1

Overall survival (OS) rate

Will calculate time from random assignment until death from any cause.

Time frame
2 year
2

Relapse incidence

Will calculate time from random assignment until relapse or disease progression.

Time frame
2 year
3

Non-relapse mortality (NRM) incidence

Defined as death from any cause not subsequent to relapse or disease progression.

Time frame
2 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov

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