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

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ClinicalTrials.gov Identifier: NCT02042690
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : May 29, 2019
Sponsor:
Collaborators:
Peking Union Medical College Hospital
Wuhan Union Hospital, China
Chinese PLA General Hospital
The First Affiliated Hospital of Soochow University
Peking University Aerospace Centre Hospital
Information provided by (Responsible Party):
Xiao-jun Huang,MD, Peking University

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Procedure: Haplo-identical HSCT Drug: Chemotherapy Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After 1 year of enrollment, randomization was terminated because of the patients's intention to crossover between the two intervention groups (total enrolled n=16). The sample size was recalculated in July 2015, and the ethics committee agreed to modify the randomization scheme to intention-to-therapy (ITT). Patients who met the recruitment criteria after the second consolidation participated fully in discussions with their doctors and then made decisions on their own regarding their intention to receive haplo-SCT. For each patient, informed consent was obtained from that patient or his/her guardian in accordance with the Declaration of Helsinki.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study to Compare Haplo-identical HSCT Versus Chemotherapy in First Remission for Standard-risk Adult Acute Lymphoblastic Leukemia
Actual Study Start Date : July 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : April 2019


Arm Intervention/treatment
Active Comparator: chemotherapy

Drugs:

Drug:Methotrexate 1g/m2 d1,IV (in the vein) , used in cycle 1,3,5 Drug:arabinoside 2-3g/m2,q12h, d2-3, IV, used in cycle 1,3,5 Drug:cyclophosphamide:300mg/m2 q12h, d1-3, IV,used in cycle 2,4,6 Drug:Epirubicin 60mg/m2.d,d4,used in cycle 2,4,6 Drug:Vindesin 4mg/d,d4,d11, IV,in cycle 2,4,6 Drug:dexamethasone 40mg/d,d1-4,d11-14, IV, in cycle 2,4,6 Drug:Methotrexate 20 mg/m2/w,po, during maintenance treatment for 2 years Drug:6-mercaptopurine 60 mg/m2/d,po,d1-d28,during maintenance treatment for 2 years Drug:Vindesin 4mg/d,Predisone:1mg/kg, d1-7, every month during maintenance treatment for 2 years

Drug: Chemotherapy
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

Experimental: Haplo-identical HSCT
Haplo-identical HSCT Protocol:G, donor treatment with recombinant granulocyte colony-stimulating factor (rhG-CSF); I, intensified immunologic suppression; A, antihuman thymocyte immunoglobulin (ATG) for the prevention of GVHD; C, combination of peripheral blood stem cell transplantation (PBSCT), and bone marrow transplantation (BMT),named GIAC regimen. Graft versus-host disease(GVHD) prevention regimen: CSA/MMF/MTX, cyclosporine A(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 HSCt and then gradually tapered. Every 12h, 0.5g mycophenolate mofetil (MMF)(0.25g for children) was administrated orally from day -10 to +30 and subsequently 0.25g from days +30 to +60. Methotrexate (MTX) was administrated at a dose of 15mg/m2 on day +1 and 10mg/m2 on days +3,+6, and +11.
Procedure: Haplo-identical HSCT
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.




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: At 2 years from study entry ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042690


Locations
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China, Beijing
Aerospace Center Hospital
Beijing, Beijing, China, 100044
China, Hubei
Wuhan Union Hospital
Wuhan, Hubei, China
China, Jiangsu
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
China
General Hospital of PLA
Beijing, China
Peking Union Hospital
Beijing, China
Sponsors and Collaborators
Peking University
Peking Union Medical College Hospital
Wuhan Union Hospital, China
Chinese PLA General Hospital
The First Affiliated Hospital of Soochow University
Peking University Aerospace Centre Hospital
Investigators
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Principal Investigator: Xiao-Jun Huang, MD Peking University People's Hospital

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Responsible Party: Xiao-jun Huang,MD, Peking University People's Hospital, Peking University
ClinicalTrials.gov Identifier: NCT02042690     History of Changes
Other Study ID Numbers: ALL-13
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao-jun Huang,MD, Peking University:
Acute Lymphoblastic Leukemia
hematopoietic stem cell transplantation
chemotherapy
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Epirubicin
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Cyclophosphamide
Methotrexate
Mercaptopurine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents