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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-002811-29
    Sponsor's Protocol Code Number:PDX-008
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-12
    Trial 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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-002811-29
    A.3Full title of the trial
    A Multi-center Phase 2 Open-label Study of (RS)-10-Propargyl-10-Deazaaminopterin (pralatrexate) with Vitamin B12 and Folic Acid Supplementation in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
    A.4.1Sponsor's protocol code numberPDX-008
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAllos Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namepralatrexate
    D.3.2Product code PDX
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPralatrexate
    D.3.9.1CAS number 146464-95-1
    D.3.9.2Current sponsor codePDX
    D.3.9.3Other descriptive name10-Propargyl-10-deazaaminopterin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeChemotherapy product
    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
    Phase 2 Open-label Study of (RS)-10-Propargyl-10-Deazaaminopterin (pralatrexate) with Vitamin B12 and Folic Acid Supplementation in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the efficacy of pralatrexate with concurrent Vitamin B12 and Folic Acid Supplementation when administered to Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
    E.2.2Secondary objectives of the trial
    Determine the safety of pralatrexate with concurrent Vitamin B12 and Folic Acid Supplementation when administered to Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

    Determine the pharmacokinetic profile of pralatrexate when administered with Vitamin B12 and Folic Acid Supplementation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has histologically/cytologically confirmed PTCL, using the Revised European
    American Lymphoma (REAL) WHO disease classification:
    a. T/NK-cell leukemia/lymphoma
    b. Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
    c. Angioimmunoblastic T-cell lymphoma
    d. Blastic NK lymphoma (with skin, lymph node, or visceral involvement)
    e. Anaplastic large cell lymphoma, primary systemic type
    Allos Therapeutics, Inc.
    Protocol PDX-008 Page 37
    f. PTCL – unspecified
    g. T/NK-cell lymphoma – nasal
    h. Enteropathy-type intestinal lymphoma
    i. Hepatosplenic T-cell lymphoma
    j. Extranodal peripheral T/NK-cell lymphoma – unspecified
    k. Subcutaneous panniculitis T-cell lymphoma
    l. Transformed mycosis fungoides
    2. Patient has documented progression of disease after at least 1 prior treatment.
    Patients may not have received experimental drugs or biologics as their only prior
    therapy. Patient must have clear disease progression after the last treatment received.
    Patient has at least 1 biopsy from initial diagnosis or in the relapsed setting to confirm
    the diagnosis of PTCL. Patient has recovered from the toxic effects of prior therapy.
    Patients treated with a FDA-approved monoclonal antibody therapy may be enrolled
    regardless of the time frame of the therapy if they have progression of disease.
    3. ECOG Performance Status ≤ 2.
    4. At least 18 years of age.
    5. Adequate hematological, hepatic, and renal function as defined by: ANC ≥ 1000/µL,
    platelet count ≥ 100,000/µL (at both screening and within 3 days prior to dosing on
    cycle 1, day 1), total bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST) and
    ALT ≤ 2.5 × ULN, (AST/ALT < 5 × ULN if documented hepatic involvement with
    lymphoma), creatinine ≤ 1.5 mg/dL (if the patient’s creatinine is > 1.5 mg/dL, then
    the calculated creatinine clearance must be ≥ 50 mL/min).
    6. Women of childbearing potential must agree to practice a medically acceptable
    contraceptive regimen from study treatment initiation until at least 30 days after the
    last administration of pralatrexate and must have a negative serum pregnancy test
    within 14 days prior to the first day of study treatment. Patients who are
    postmenopausal for at least 1 year (> 12 months since last menses) or are surgically
    sterilized do not require this test.
    7. Men who are not surgically sterile must agree to practice a medically acceptable
    contraceptive regimen from study treatment initiation until at least 90 days after the
    last administration of pralatrexate.
    8. Patient has given written informed consent (IC).
    E.4Principal exclusion criteria
    1. Patient has:
    a. Precursor T/NK neoplasms, with the exception of blastic NK lymphoma
    b. T-PLL
    c. T-cell large granular lymphocytic leukemia
    d. Mycosis fungoides, other than transformed mycosis fungoides
    e. Sézary syndrome
    f. Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and
    lymphomatoid papulosis
    2. Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in
    situ of the cervix). If there is a history of prior malignancy, the patient must be
    disease-free for ≥ 5 years.
    3. Congestive heart failure Class III/IV according to the New York Heart Association’s
    Heart Failure Guidelines.
    4. Uncontrolled hypertension.
    5. Human immunodeficiency virus (HIV)-positive diagnosis and is receiving
    combination anti-retroviral therapy.
    6. Patient has, or history of, brain metastases or central nervous system (CNS) disease.
    7. Patient has undergone an allogeneic stem cell transplant.
    8. Patient has relapsed less than 75 days from time of an autologous stem cell transplant.
    9. Active uncontrolled infection, underlying medical condition including unstable
    cardiac disease, or other serious illness that would impair the ability of the patient to
    receive protocol treatment.
    10. Patient has had major surgery within 2 weeks of study entry.
    11. Receipt of any conventional chemotherapy or radiation therapy (RT) within 4 weeks
    (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use
    during the course of the study.
    12. Receipt of corticosteroids within 7 days of study treatment, unless patient has been
    taking a continuous dose of no more than 10 mg/day of prednisone for at least
    1 month.
    13. Use of any investigational drugs, biologics, or devices within 4 weeks prior to study
    treatment or planned use during the course of the study.
    14. Previous exposure to pralatrexate.
    E.5 End points
    E.5.1Primary end point(s)
    Response 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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-02-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 100
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-22
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