Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia:

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

Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia:

Official Title

Pegylated Liposomal Doxorubicin-contained Versus Daunorubicin-contained VDCLD Regimen in Previously Untreated Adult Patients With Acute Lymphoblastic Leukemia: Complete Remission Rates and Changes of Leukemia Stem Cells

Brief Summary

      To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD)
      inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with
      VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether
      chemotherapy containing PLD with a higher response rates and greater safety in adult ALL
    

Detailed Description

      This is a prospective, multicenter, open, non-intervention clinical study, with estimated
      enrollment of 200 newly diagnosed adult ALL patients. After the first course of treatment
      administered with PLD-contained or DNR-contained VDCLD regimen, CR rate and changes of
      leukemia stem cells in bone marrow, was evaluated; the safety of these chemotherapy was also
      evaluated.

      Study Patients:

      Patients included in this study should be untreated with ALL previously, being in line with
      the inclusion criteria and exclusion criteria.

      Dosage and Administration:

      PLD-contained VDCLD regimen:PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m
      iv(d1,8,15,22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19~28),Dex10mg ivdrip
      (d1~28).

      DNR-contained VDCLD regimen:DNR 45 mg/m2 ivdrip over 60 minutes(d1~3),VCR 1.4mg/m2
      iv(d1,d8,d15,d22), CTX 800 mg/m2 ivdrip(d1), L-asp 6000u/m2 ivdrip(d19~28),Dex10mg
      ivdrip(d1~28).

      Endpoints:

      Primary endpoint: The primary endpoint of the study was complete remission (CR) rates after
      the first course of regimen. The proportion of patients achieved CR was evaluated, after the
      first course of induction chemotherapy administered with PLD-contained or DNR-contained VDCLD
      regimen Secondary endpoint: The change of leukemia stem cells in bone marrow, was evaluated
      before and after administered with PLD-contained or DNR-contained VDCLD regimen.

      Safety Assessment:

      In order to adjust the treatment strategy and ensure patients' safety effectively, routine
      blood test, transaminases, and creatinine was monitored on time during the period, while lung
      CT and ECG was performed based on clinical need. Possible adverse reactions and tolerability
      during treatment, such as gastrointestinal reactions, cardiac function, as well as
      discontinuation ratio due to side effects or tolerability of PLD, was recorded.

      Statistical Analysis:

      All the calculations were performed with the SPSS statistical software. The continuous
      variables were performed with T test; categorical variables were performed withχ2 test. After
      acceptance of various observation records sheets, data were unified processed.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Complete remission (CR) rates after the first course of regimen

Secondary Outcome

 The change of leukemia stem cells in bone marrow

Condition

Acute Lymphoblastic Leukemia

Intervention

VDCLD regimen

Study Arms / Comparison Groups

 PLD-contained VDCLD regimen
Description:  PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1,8,15,22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19~28),Dex10mg ivdrip (d1~28).

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

Drug

Estimated Enrollment

200

Start Date

December 2013

Completion Date

December 2015

Primary Completion Date

November 2015

Eligibility Criteria

        Inclusion Criteria:

        Eligible men or women were age over 14,but less than 60 years;

        Eastern Cooperative Oncology Group performance status of 0 to2;

        Diagnosed with ALL (WHO classification, the primitive cells ≥ 20%);

        Previous untreated ALL patients had not received chemotherapy before (excluding
        dexamethasone, prednisone, and hydroxyurea). History of receiving blood transfusion,
        hematopoietic growth factors, vitamin, and palliative measures such as leukocyte removal,
        dexamethasone, prednisone, hydroxyurea (0.5-3g daily, more than three days) is allowed;

        The levels of LSCs in bone marrow were measured with flow cytometry before treatment;

        Subjects must be able to provide written informed consent.

        Exclusion Criteria:

        Mixed type of AL patients;

        Clinically significant active infections;

        Nursing (breastfeeding) or intending to be nursing during the study;

        Pregnancy, or intending to become pregnant during the study;

        Patients with cardiac dysfunction currently (especially congestive heart failure) or
        history of congestive heart failure;

        Patients with severe liver failure (ALT ≥ 5 times the upper limit of normal (ULN), total
        bilirubin ≥ 3mg/dL)

        Patients with renal insufficiency, creatinine clearance <30ml/min, creatinine clearance
        rate is calculated as follows: Men: Ccr (ml / min) = (140 - age) × weight (kg) / [0.8136 ×
        serum creatinine (μmol / L )] female: Ccr (ml / min) = (140 - age) × weight (kg) × 0.85 /
        [0.8136 × serum creatinine (μmol / L)];

        Patients did not or will not participate in other trials of drugs 30 days before or 90 days
        after the beginning of this study,
      

Gender

All

Ages

14 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Zhigang Yang, +86 13560512702, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02070523

Organization ID

ChangzhouJP


Responsible Party

Sponsor

Study Sponsor

Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.

Collaborators

 CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study Sponsor

Zhigang Yang, Principal Investigator, The Affiliated Hospital of Guangdong Medical College


Verification Date

February 2014