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    Summary
    EudraCT Number:2010-022946-25
    Sponsor's Protocol Code Number:AALL0622
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-12-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2010-022946-25
    A.3Full title of the trial
    Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
    A.4.1Sponsor's protocol code numberAALL0622
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00720109
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/200/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChildren's Oncology Group
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportChildren's Oncology Group
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportNational Cancer Institute
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Children’s Hospital of Philadelphia
    B.5.2Functional name of contact pointPeter C. Adamson - COG Group Chair
    B.5.3 Address:
    B.5.3.1Street Address3501 Civic Center Blvd, CTRB 10060
    B.5.3.2Town/ cityPhiladelphia
    B.5.3.3Post codePA 19104
    B.5.3.4CountryUnited States
    B.5.4Telephone number1(215) 590-6359
    B.5.5Fax number1(215) 590-7544
    B.5.6E-mailAdamson@email.chop.edu
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/338-339
    D.3 Description of the IMP
    D.3.1Product nameDasatinib
    D.3.2Product code BMS-354825
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDASATINIB
    D.3.9.1CAS number 302962-49-8
    D.3.9.2Current sponsor codeBMS-354825
    D.3.9.4EV Substance CodeSUB23322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/338-339
    D.3 Description of the IMP
    D.3.1Product nameDasatinib
    D.3.2Product code BMS-354825
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDASATINIB
    D.3.9.1CAS number 302962-49-8
    D.3.9.2Current sponsor codeBMS-354825
    D.3.9.4EV Substance CodeSUB23322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/338-339
    D.3 Description of the IMP
    D.3.1Product nameDasatinib
    D.3.2Product code BMS-354825
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDASATINIB
    D.3.9.1CAS number 302962-49-8
    D.3.9.2Current sponsor codeBMS-354825
    D.3.9.4EV Substance CodeSUB23322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)
    E.1.1.1Medical condition in easily understood language
    Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000844
    E.1.2Term Acute lymphoblastic leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10034877
    E.1.2Term Philadelphia chromosome positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To determine the feasibility and toxicity of dasatinib in combination with intensified chemotherapy in young patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
    •To determine whether the intensification of tyrosine kinase inhibition (TKI) through the addition of dasatinib to induction therapy (on days 15-28) and the substitution of dasatinib for imatinib mesylate during post-induction therapy will lead to a 3-year event-free survival (EFS) in ≥ 60% of these patients.
    E.2.2Secondary objectives of the trial
    •To determine whether the addition of dasatinib to induction therapy will decrease levels of minimal residual disease (MRD) present at the end of induction therapy as compared with MRD levels in patients treated on COG-AALL0031.
    •To determine whether early intensified TKI therapy (dasatinib) will lower levels of MRD at the end of consolidation therapy as compared with MRD levels in patients who received imatinib mesylate during blocks 1 and 2 consolidation therapy (cohorts 3-5) on COG-AALL0031.
    •To determine the overall 3-year EFS rate for both standard- and high-risk patients treated with dasatinib.
    •To determine the long-term effects of dasatinib on growth, development, and bone metabolism.
    •To assess BCR-ABL mutation status at time of diagnosis and progression/relapse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    DISEASE CHARACTERISTICS:
    •Newly diagnosed acute lymphoblastic leukemia (ALL)
    ◦Definitive evidence of BCR-ABL fusion (Philadelphia chromosome positive [PH+]) from an approved Children's Oncology Group (COG) cytogenetics laboratory
    •Meets one of the following criteria:
    ◦Concurrent enrollment on COG-AALL03B1 (or a successor trial) AND COG-AALL0232, COG-AALL0331, COG-AALL0434 or other front-line COG ALL clinical trial
    ◦Concurrent enrollment on COG-AALL03B1 (or a successor trial) AND scheduled to receive a 3 or 4-drug standard induction regimen
    ◦Concurrent enrollment on a DFCI Childhood ALL Consortium trial (or scheduled to be treated as per a DFCI Childhood ALL Consortium induction regimen)
    •Received the first 2 weeks of induction therapy prior to study enrollment
    ◦Patients may NOT have received day 15 of induction therapy (or day 18 if enrolled on a DFCI Childhood ALL Consortium trial)
    •No Down syndrome
    PATIENT CHARACTERISTICS:
    •Karnofsky performance status (PS) 50-100% (for patients > 16 years of age)
    •Lansky PS 50-100% (for patients ≤ 16 years of age)
    •Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR maximum serum creatinine based on age and gender as follows:
    ◦0.4 mg/dL (for patients 1 to 5 months of age)
    ◦0.5 mg/dL (for patients 6 to 11 months of age)
    ◦0.6 mg/dL (for patients 1 year of age)
    ◦0.8 mg/dL (for patients 2 to 5 years of age)
    ◦1.0 mg/dL (for patients 6 to 9 years of age)
    ◦1.2 mg/dL (for patients 10 to 12 years of age)
    ◦1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
    ◦1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)
    •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
    •ALT < 2.5 times ULN
    •Shortening fraction ≥ 27% by echocardiogram OR LVEF ≥ 50% by gated radionuclide study
    •QTc ≤ 0.45 seconds by EKG
    •Not pregnant or nursing
    •Negative pregnancy test
    •Fertile patients must use effective contraception
    •No evidence of dyspnea at rest
    •No exercise intolerance
    •Pulse oximetry > 94% at sea level (if there is a clinical indication for determination)
    •Seizure disorder allowed provided it is well controlled on anticonvulsants
    PRIOR CONCURRENT THERAPY:
    •No other concurrent cancer chemotherapy or immunomodulatory agents (including steroids)
    E.4Principal exclusion criteria
    • Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method.
    • Female patients who are lactating must agree to stop breast-feeding.
    • Patients with Down syndrome
    • Patients with QTc greater than 0.45 seconds. Patients must have an EKG fewer than 6 days prior to enrollment onto AALL0622.
    E.5 End points
    E.5.1Primary end point(s)
    •Feasibility as assessed by examining the adverse events, delays in administering combination therapy, minimal residual disease (MRD) levels at the completion of induction therapy and consolidation therapy, and event-free survival (EFS)
    •Toxicity as assessed by NCI CTCAE v3.0
    •3-year event-free survival (EFS) of patients with standard-risk disease treated with dasatinib in combination with intensified chemotherapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    •At the end-of-induction - Day 28
    •At the end-of-consolidation block 2
    •Overall 3-year EFS rate
    E.5.2Secondary end point(s)
    •Comparison of the end-of-induction minimal residual disease (MRD) levels in patients treated with dasatinib on this study with the end-of-induction MRD levels in patients treated on clinical trial COG-AALL0031
    •Comparison of the end-of-consolidation MRD levels in patients treated with dasatinib on this study with the end-of-consolidation MRD levels in patients treated with imatinib mesylate during blocks 1 and 2 consolidation therapy (cohorts 3-5) on COG
    •Overall 3-year EFS rate for both standard- and high-risk patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    •At the end-of-induction - Day 28
    •At the end-of-consolidation block 2
    •Overall 3-year EFS rate
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Australia
    Canada
    New Zealand
    Puerto Rico
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 58
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 7
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 114
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 54
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Chldren from 1 to 30 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 195
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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