European Leukemia Trial Registry
Trial: ONO 1910

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Public Title Randomized Study of ON 01910.Na in Refractory MDS With Excess Blasts
Scientific Title Phase III MultiCenter Randomized Controlled Study to Assess Efficacy and Safety of ON 01910.Na 72-Hr Continuous IV Infusion in MDS Patients With Excess Blasts Relapsing After or Refractory to or Intolerant to Azacitidine or Decitabine
Short Title ONO 1910
Id KN/ELN LN_NN_2010_473
Trialgroup NN
Type of Trial multicentric, randomized, open-label
Phase Phase III
Disease Myelodysplastic Syndrome(MDS) Intermedia II and high risk
Stage of Disease .
Aim
  • Overall survival
  • Overall response (complete and partial remission) according to 2006 IWG criteria
  • Complete bone marrow response according to 2006 IWG criteria
  • Hematological improvements according to 2006 IWG criteria
  • Scores of Quality of Life Questionnaire
  • Adverse events
  • Change in Aneuploidy
  • Transition time to AML
  • Incidence of infections and bleeding episodes.
Inclusion Criteria
  • MDS diagnosis confirmed within 6 weeks prior to entry according to WHO or FAB classification
  • MDS classified as follows, according to WHO and FAB classification:
  • a. RAEB-1 (5% - 9% BM blasts)
  • b. RAEB-2 (10% - 20% BM blasts)
  • c. CMML (10% - 20% BM blasts) and WBC < 13,000/μL
  • d. RAEB-t (21% - 30% BM blasts), with following criteria:
  • aa. WBC < 25 x 10E9/L at entry
  • bb. Stable WBC at least 4 weeks prior to entry and not requiring intervention for WBC control with hydroxyurea, chemotherapy, or leukopheresis.
  • At least one cytopenia (ANC < 1800/L or platelet count < 100,000/L or hemoglobin <10 g/dL)
  • Progression according to 2006 International Working Group (IWG) criteria any time after start of azacitidine or decitabine during past 2 years; or failure to achieve complete or partial response or hematological improvement (according to 2006 IWG) after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine during past 2 years; or relapse after initial complete or partial response or hematological improvement (according to 2006 IWG criteria) observed after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine during past 2 years; or, intolerance to azacitidine or decitabine defined by drug-related ≥Grade 3 liver or renal toxicity leading to discontinuation during the past 2 years.
  • Did not respond to, relapsed after, not eligible for, or opted not to do bone marrow transplantation
  • Off other MDS treatments for at least 4 weeks; Filgrastim (G-CSF) and erythropoietin allowed before and during the study as clinically indicated.
  • No need for induction chemotherapy
  • ECOG status 0, 1 or 2
  • Willing to adhere to protocol prohibitions and restrictions
  • Patient (or a legally authorized representative) must sign informed consent form to indicate patient's understanding study's purpose and procedures and willingness to participate
Exclusion Criteria
  • Anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding) unless stabilized for 1 week after RBC transfusion.
  • Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Active infection not adequately responding to appropriate therapy
  • Total bilirubin >=1.5 mg/dL not related to hemolysis or Gilbert's disease.
  • Alanine transaminase (ALT)/aspartate transaminase (AST) >= 2.5 x upper limit of normal (ULN)
  • Serum creatinine >= 2.0 mg/dL
  • Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 mEq/L)
  • Pregnant or lactating females
  • Patients unwilling to follow strict contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device, double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study
  • Females with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin pregnancy test at screening
  • Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start
  • Uncontrolled hypertension (defined as systolic pressure ≥160 mmHg and/or diastolic pressure ≥110 mmHg)
  • New onset seizures (within 3 months prior to first dose of ON 01910.Na) or poorly controlled seizures
  • Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy
  • Prior treatment with low-dose cytarabine during past 2 years Investigational therapy within 4 weeks of starting ON 01910.Na
  • Psychiatric illness or social situation that limits the patient's ability to tolerate and/or comply with study requirements
Age >= 18 years
Status No longer recruiting
Start of Recruitment 01.11.2010
Target Sample Size 270
Contact Person

Principal Investigator
Platzbecker, Prof. Dr. med., Uwe
Tel: +49 (0)351 4582583
Fax: +49 (0)351 458-5362
Email: Uwe.Platzbecker@uniklinikum-dresden.de

Shortprotocol Shortprotocol
Sponsors Onconova Therapeutics, Inc. (Main Sponsor)
Supporters Onconova Therapeutics, Inc.
Other Registers ClinicalTrials.gov NCT01241500
European Clinical Trials Database - EUDRACT 2010-019755-21
created 10.01.2012 Johannes Kraus
changed 29.10.2013 Sina Hehn
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