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Completed

NCT Number: NCT02671708

IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT

Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.

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Key information

Conditions

Autologous Hematopoietic Stem Cell Transplantation Acute Myeloid Leukemia Conditioning Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

Auto-HSCT is an effective alternative to allogeneic HSCT for intermediate-risk AML without HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen. However, auto-HSCT with BUCY conditioning regimen appears to have higher relapse rate. To reduce the relapse rate, IDA is added in the conditioning regimen. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML patients undergoing auto-HSCT are evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intermediate-risk AML
  • Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens
  • With negative MRD before mobilization and collect of peripheral blood stem cells
  • Without HLA-matched donors (related and unrelated)
  • Refusal of haploidentical hematopoietic stem cell transplantation

Exclusion criteria

  • 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)

Treatment and study plan

Idarubicin（IDA）

Drug

Idarubicin was administered at 15mg/m2/day on days -12 and -10.

Busulfan (BU)

Drug

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Cyclophosphamide (CY)

Drug

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Primary outcomes

  1. leukemia relapse rate

    Time frame: 2 year

Secondary outcomes

  1. overall survival (OS)

    Time frame: 2 year

  2. disease-free survival (DFS)

    Time frame: 2 year

  3. transplant-related mortality (TRM)

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Guangzhou First People's Hospital
  • Peking University People's Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Zhujiang Hospital

Registry information

Official study title

Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Feb 2, 2016
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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