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NCT Number: NCT02042690

Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients

The survival of adult patients with standard-risk acute lymphoblastic leukemia(ALL) need to improve. We want to compare the efficacy of haplo-identical hematopoietic stem cell transplantation (HSCT) with chemotherapy for adult(age:18-39 years old) ALL patients in first phase of complete remission (CR1)

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aerospace Center Hospital, Beijing, Beijing Municipality, China

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About this study

Although the high complete remission rate (80%-90%) can be achieved, the long-term survival rate of standard-risk adult patients with acute lymphoblastic leukemia(ALL) is only 25%-55% when they receive chemotherapy alone. The survival rate can be further improved uo to 50%-75% when they receive HLA-matched HSCT However, the chance of finding a HLA-matched donor is low, especially in China. Alternative donor such as halpo-identical related donor might be an choice.

Our retrospective analysis showed about 59% overall survival could be achieved when standard-risk adult ALL patients received halpo-identical HSCT.Therefore, we start this randomization controlled trial to compare the efficacy of haplo-identical HSCT with chemotherapy for adult(age:18-39 years old) ALL patients in CR1.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • acute lymphoblastic leukemia
  • 18-39 years old
  • in first complete remission -Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤2.5 times the institutional ULN -
  • Adequate renal function defined as creatinine ≤3 times the institutional ULN
  • No uncontrollable infection
  • Performance Status(PS)score 0-2(WHO)
  • Subjects able to provide written informed consent

Exclusion criteria

  • having HLA-matched donor
  • high-risk ALL: (1)Ph+ALL (2)Hypodiploidy (3)t(v;11q23) (4) complex karyotype（≥5 chromosome abnormalities）（5）high white blood cell (WBC) count (B-ALL≥30×109/L;T-ALL ≥100×109/L).
  • pregnancy
  • Loss of ability to freely provide consent due to psychiatric or physical illness

Treatment and study plan

Haplo-identical HSCT

Procedure

Haplo-identical Protocol: myeloablative human leukocyte antigen (HLA) haploidentical stem cell transplantation (haplo-SCT) using pretransplant ATG and granulocyte colony-stimulating factor (G-CSF)-stimulated grafts (ATG+G-CSF) GVHD prevention regimen: CSA/MMF/MTX, CSA 1.25mg/kg/d, i.v administrated in two doses from day -109 until bowel function returned to normal, at which time patients receive oral CSA until 12months after HRD-HSC and then gradually tapered. Every 12h, 0.5g MMF(0.25g for children) was administrated orally from day -10 to +30 and subsequently 0.25g from days +30 to +60. MTX was administrated at a dose of 15mg/m2 on day +1 and 10mg/m2 on days +3,+6, and +11.

Chemotherapy

Drug

Patients receive 6 cycles of consolidation chemotherapy after randomization, including Hyper-CVAD-B regimen-Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen.Maintenance treatment includes MTX 20mg/m2/w，po，6-mercaptopurine 60 mg/m2/d，po，d1-d28，VP（VDS 4mg,d1, Prednisone 1mg/kg d1-7) every one month for 2 years.

Other names: Methotrexate, arabinoside, cyclophosphamide, Epirubicin, dexamethasone, 6-mercaptopurine, Vindesin, Predisone

Primary outcomes

  1. Disease-free survival

    Time frame: At 2 years from study entry

Secondary outcomes

  1. Rate of cumulative incidence of relapse

    Time frame: At 2 years from study entry

  2. Overall survival (OS) rate

    Time frame: At 2 years from study entry

  3. nonrelapse mortality

    Time frame: At 2 years from study entry

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Chinese PLA General Hospital
  • Peking Union Medical College Hospital
  • Peking University Aerospace Center Hospital
  • The First Affiliated Hospital of Soochow University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

Phase III Study to Compare Haplo-identical HSCT Versus Chemotherapy in First Remission for Standard-risk Adult Acute Lymphoblastic Leukemia

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jan 23, 2014
Registry last updated
May 29, 2019

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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