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

Related Clinical Trial
Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL) A Study Of Inotuzumab Ozogamicin Versus Investigator’s Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia Effect of Vitamin D Diffiency on Oral Mucosa in Patients Recieving Methotrexate Chemotherapy Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia: A Study of Children With Refractory or Relapsed ALL Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International Pharmacogenetically Based Dosing of Thiopurines in Childhood Acute Lymphoblastic Leukemia ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL) Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia Phase II Front-line Ponatinib in Adult Philadelphia+/BCR-ABL+ Acute Lymphoblastic Leukemia. Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia Clofarabine-cyclophosphamide as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) Adults Study Evaluating the Efficacy and Safety of JCAR015 in Adult B-cell Acute Lymphoblastic Leukemia (B-ALL) Induction Therapy With Cytarabine, High-Dose Mitoxantrone and Dasatinib for Patients With Philadelphia-Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL) Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia (ALL) Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Ph-Positive ALL CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL) A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients Rapamycin in Relapsed Acute Lymphoblastic Leukemia Treatment of Childhood Acute Lymphoblastic Leukemia Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia The Influence of Thiopurine Methyltransferase Activity on Toxicity After High-dose Methotrexate in Childhood Acute Lymphoblastic Leukemia CD19-CAR Immunotherapy for Childhood Acute Lymphoblastic Leukemia (ALL) Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL) Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 A Comparison of Reduced Dose Total Body Irradiation (TBI) and Cyclophosphamide With Fludarabine and Melphalan Reduced Intensity Conditioning in Adults With Acute Lymphoblastic Leukaemia (ALL) in Complete Remission. (ALL-RIC) Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia Pharmacokinetic Profile of Vincristine Administered With Imatinib for Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) Compared to That Without Imatinib for Bcr-Abl Negative ALL Phase III B in Acute Lymphoblastic Leukemia The Effects of Honey on Febrile Neutropenia in Children With Acute Lymphoblastic Leukemia Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia Treatment of Acute Lymphoblastic Leukemia in Children PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents Treatment of High Risk Adult Acute Lymphoblastic Leukemia Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Acute Lymphoblastic Leukemia (B-ALL) Medical Research Council (MRC) Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003 A Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL) The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia Cladribine in Combination With GAP in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I Study of Sirolimus With PEG-Asparaginase in Acute Lymphoblastic Leukemia (ALL) Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph ‘Negative in Elderly Patients (> 55 Years) Home-exercise Program for Children and Adolescent Survivors of Acute Lymphoblastic Leukemia The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008 A Study Evaluating KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia Treatment of Older Adults With Acute Lymphoblastic Leukemia Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+ CTA101 UCAR-T Cell Injection for Treatment of Relapsed or Refractory CD19+ B-cell Acute Lymphoblastic Leukemia Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) Osteonecrosis in Children With Acute Lymphoblastic Leukemia Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) Pentoxifylline In Pediatric Acute Lymphoblastic Leukemia During Induction Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL) Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL) STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia A Study in Adults With Untreated Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia Relapse in Sweden 2003-2007 The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop Cancer Care Delivery in Adolescent and Young Adult Patients With Acute Lymphoblastic Leukemia Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients Metformin Reduce the Relapse Rate on Patients With B-cell Precursor (Ph+ Negative) Acute Lymphoblastic Leukemia Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals Genomic Changes in Childhood Acute Lymphoblastic Leukemia Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children. Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL) Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia A Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia New Markers for Minimal Residual Disease in Acute Lymphoblastic Leukemia Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia FoxO3a and PU.1 in Acute Lymphoblastic Leukemia Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia Genome-wide Single Nucleotide Polymorphism (SNP) Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Lymphoblastic Leukemia Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)

Brief Title

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

Official Title

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

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)
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Disease-free survival

Secondary Outcome

 Rate of cumulative incidence of relapse

Condition

Acute Lymphoblastic Leukemia

Intervention

Haplo-identical HSCT

Study Arms / Comparison Groups

 chemotherapy
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

131

Start Date

July 2014

Completion Date

April 2019

Primary Completion Date

February 2018

Eligibility 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
      

Gender

All

Ages

18 Years - 39 Years

Accepts Healthy Volunteers

No

Contacts

Xiao-Jun Huang, MD, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02042690

Organization ID

ALL-13


Responsible Party

Principal Investigator

Study Sponsor

Peking University

Collaborators

 Peking Union Medical College Hospital

Study Sponsor

Xiao-Jun Huang, MD, Principal Investigator, Peking University People's Hospital


Verification Date

May 2019