Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts (ONTIME)
This study is currently recruiting participants.
Verified April 2013 by Onconova Therapeutics, Inc.
Sponsor:
Onconova Therapeutics, Inc.
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Onconova Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01241500
First received: November 1, 2010
Last updated: April 16, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes MDS RAEB Chronic Myelomonocytic Leukemia |
Drug: ON 01910.Na |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Onconova Therapeutics, Inc.:
Primary Outcome Measures:
- Overall survival [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]Overall survival (OS) is defined as the time from randomization to death from any cause. All patients will be followed until death or progression, even if they have discontinued treatment for whatever cause. Patients lost to follow-up will be censored at the time last known alive. The OS primary analysis will compare the active ON 01910.Na regimen to BSC once a total number of 223 deaths has been reached.
Secondary Outcome Measures:
- Overall response (complete and partial remission) according to 2006 IWG criteria [ Time Frame: Changes measured at Week 4 from Baseline and every 8 Weeks thereafter ] [ Designated as safety issue: No ]Compare the BSC + ON 01910.Na group to the BSC group with respect to changes in bone marrow myeloblasts, hemoglobin, peripheral neutrophils, platelets and blasts.
- Complete bone marrow response according to 2006 IWG criteria [ Time Frame: Changes measured at Week 4 from Baseline and every 8 Weeks thereafter ] [ Designated as safety issue: No ]Compare the BSC + ON 01910.Na group to the BSC group with respect to changes in bone marrow myeloblasts.
- Hematological improvements according to 2006 IWG criteria [ Time Frame: Weekly ] [ Designated as safety issue: No ]Compare the BSC + ON 01910.Na group to the BSC group with respect to in absolute neutrophil count (ANC), platelet count, and erythroid responses.
- Scores of Quality of Life Questionnaire [ Time Frame: Measured at Baseline and every 4 Weeks ] [ Designated as safety issue: No ]Compare the BSC + ON 01910.Na group to the BSC group with respect to scores of Quality-of-life (QOL)(using the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30 version 3.
- Adverse events [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]Record adverse events according to CTCAE v4.
- Change in Aneuploidy [ Time Frame: Baseline and, only if abnormal at Baseline, Week 4 and every 8 Weeks thereafter ] [ Designated as safety issue: No ]Improvements of cytogenetics as evaluated by the change in aneuploidy in bone marrow according to 2006 IWG criteria.
- Transition time to AML [ Time Frame: Measured at Week 4 from date of randomization and every 8 Weeks thereafter ] [ Designated as safety issue: No ]Transition time to AML: Defined for RAEB-1 and RAEB-2 MDS and chronic myelomonocytic leukemia (CMML) patients (with BM blasts from 10% to 20% for CMML) by an increase of at least 50% BM blasts and more than 20% BM blasts; Defined for RAEB-t by an increase of at least 50% BM blasts.
- Incidence of infections and bleeding episodes. [ Time Frame: Every 4 Weeks ] [ Designated as safety issue: Yes ]Incidence of infections (treated with intravenous antimicrobials) and bleeding episodes.
| Estimated Enrollment: | 270 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ON 01910.Na + best supportive care (BSC)
Patients will receive ON 01910.Na 1800 mg/24 hr as a continuous intravenous infusion for 72 hours every other week for the first 16 weeks then every 4 weeks afterwards and best supportive care (BSC).
|
Drug: ON 01910.Na
The dose of ON 01910.Na will be 1800 mg/24 hr as a continuous intravenous infusion for 72 hours every other week for the first 16 weeks then every 4 weeks afterwards. Infusion bags must be changed every 24 hours and a new infusion bag must be used for each of the subsequent 24 hours until completion of the total 72-hour infusion time.
Other Name: rigosertib
|
|
No Intervention: Best supportive care (BSC)
Patients will receive best supportive care (BSC).
|
Detailed Description:
This is a Phase III open-label, randomized, controlled, multicenter study (up to 50 centers). Approximately 270 patients with MDS classified as RAEB-1 and RAEB-2 using the WHO classification and as RAEB-t and chronic myelomonocytic leukemia (CMML) using the FAB classification who failed, became intolerant to, or progressed after treatment with 5-azacitidine or decitabine administered during the past 2 years, will be randomized in a 2:1 ratio into the following 2 treatment regimens:
- Best Supportive Care (BSC) + ON 01910.Na 1800 mg/24 hr administered as a 72-hr continuous intravenous (CIV) infusion on Days 1, 2, and 3 of a 2-week cycle (N = approximately 180 patients)
- BSC (N = approximately 90 patients).
Patients will be stratified at entry by bone marrow (BM) blasts (5% to 19% vs. 20% to 30%). After completing the first eight 2-week cycles (i.e., after 16 weeks of treatment), the frequency of further 72-hr CIV infusions will be decreased to an administration on Days 1, 2, and 3 of a 4-week cycle.
Patients will remain treated on study until 2006 International Working Group (IWG) progression criteria are met (i.e., 50% increase of BM blasts or worsening of cytopenias) or until death from any cause, whichever comes first.
Patients who progress to Acute Myeloid Leukemia (AML) while on study should be offered either standard treatment for AML or enrollment in an appropriate investigational study if they are eligible. These treatments with their start and end dates should be documented and patient survival time will be documented for all randomized patients.
Cross-over of BSC patients to ON 01910.Na after progression will not be allowed. However, patients in the BSC-only group will be allowed, as medically justified, access to low-dose cytarabine 20 mg/m2 subcutaneously (SC) once daily for the first consecutive 14 days of each 28-day cycle, up to 4 cycles, until progression or unacceptable toxicity develops. Low-dose cytarabine will be delayed as needed until recovery of blood counts. All study participants will be allowed, as medically justified, access to RBC and platelet transfusions and to growth factors (erythropoietin, Filgrastim [G-CSF]). Hydroxyurea will be allowed to manage blastic crisis with hyperleukocytosis when patients transition to leukemia.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- RAEB-1 (5% - 9% BM blasts)
- RAEB-2 (10% - 20% BM blasts)
- CMML (10% - 20% BM blasts) and WBC < 13,000/μL
- RAEB-t (21% - 30% BM blasts), with following criteria:
- o WBC < 25 x 10E9/L at entry
- o 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/µL or platelet count < 100,000/µL 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241500
Hide Study Locations
Contacts
| Contact: Study Call Center | 855 609-6564 |
Hide Study LocationsLocations
| United States, Arizona | |
| Virginia G. Piper Cancer Center | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Principal Investigator: Mahesh Seetharam, MD | |
| United States, California | |
| University of California San Diego Moores Cancer Center | Recruiting |
| La Jolla, California, United States, 92093 | |
| Principal Investigator: Peter T. Curtin, MD | |
| Stanford Cancer Center | Recruiting |
| Stanford, California, United States, 94305 | |
| Principal Investigator: Peter L. Greenberg, MD | |
| United States, Connecticut | |
| Yale Cancer Center | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Principal Investigator: Nikolai Podoltsev, MD, PhD | |
| United States, District of Columbia | |
| Georgetown University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Principal Investigator: Catherine Broome, MD | |
| United States, Florida | |
| Integrated Community Oncology Network | Recruiting |
| Jacksonville, Florida, United States, 32256 | |
| Principal Investigator: Mehdi M. Moezi, MD | |
| Innovative Medical Research of South Florida, Inc. | Recruiting |
| Miami, Florida, United States, 33169 | |
| Principal Investigator: Mark Saltzman, MD | |
| Mount Sinai Comprehensive Cancer Centers | Recruiting |
| Miami Beach, Florida, United States, 33140 | |
| Principal Investigator: Jose Lutzky, MD | |
| Woodlands Medical Specialists | Recruiting |
| Pensacola, Florida, United States, 32503 | |
| Principal Investigator: Rami Owera, MD | |
| Martin Memorial Cancer Center | Recruiting |
| Stuart, Florida, United States, 34994 | |
| Sub-Investigator: Guillermo Abesada-Terk, Jr., MD | |
| Cleveland Clinic Florida | Recruiting |
| Weston, Florida, United States, 33331 | |
| Principal Investigator: Chieh-Lin Fu, MD | |
| United States, Georgia | |
| Emory University Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Hanna Khoury, MD | |
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Principal Investigator: Jamile Shammo, MD | |
| University of Chicago Medical Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: Lucy Godley, MD | |
| North Shore Medical Center | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| Principal Investigator: Lynne Kaminer, MD | |
| Cardinal Bernardin Cancer Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Principal Investigator: Danielle Shafer, MD | |
| Edward H. Kaplan MD & Associates | Recruiting |
| Skokie, Illinois, United States, 60076 | |
| Principal Investigator: Marlon Kleinman, MD | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Westwood, Kansas, United States, 66205 | |
| Principal Investigator: Suman Kambhampati, MD | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center | Recruiting |
| Baton Rouge, Louisiana, United States, 70809 | |
| Principal Investigator: Bryan Bienvenu, MD | |
| United States, Maryland | |
| University of Maryland Greenebaum Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Principal Investigator: Maria Baer, MD | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Principal Investigator: Steven D. Gore, MD | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: David P. Steensma, MD | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: Dale L. Bixby, MD, PhD | |
| Providence Cancer Center | Recruiting |
| Southfield, Michigan, United States, 48075 | |
| Principal Investigator: Howard R. Terebelo, DO | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: Aref Al-Kali, MD | |
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Principal Investigator: Stuart Goldberg, MD | |
| Overlook Hospital | Recruiting |
| Summit, New Jersey, United States, 07901 | |
| Principal Investigator: Neil Morganstein, MD | |
| United States, New York | |
| Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Principal Investigator: Amit Verma, MD | |
| North Shore - LIJ Health System | Recruiting |
| Lake Success, New York, United States, 11042 | |
| Principal Investigator: Steven L. Allen, MD | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Principal Investigator: Lewis R. Silverman, MD | |
| Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 10021 | |
| Principal Investigator: Gail J. Roboz, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: Mikkael Sekeres, MD | |
| United States, Oklahoma | |
| University of Oklahoma Health Science Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: Mohamad Cherry, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania Health System | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: Selina Luger, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: Robert K. Stuart, MD | |
| Bon Secours St. Francois Health System | Recruiting |
| Greenville, South Carolina, United States, 29601 | |
| Principal Investigator: Gary Spitzer, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Principal Investigator: Robert H. Collins, Jr., MD | |
| University of Texas M. D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Guillermo Garcia-Manero, MD | |
| Cancer Care Centers of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: Roger M. Lyons, MD | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Principal Investigator: Bart Scott, MD | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: Ehab Attalah, MD | |
| Belgium | |
| H. Hartziekenhuis Roeselare-Menen vzw | Recruiting |
| Roeselare, West-vlaanderen, Belgium, 8800 | |
| Principal Investigator: Dries Deeren, MD | |
| Ziekenhuis Netwerk Antwerpen | Recruiting |
| Antwerp, Belgium, 2060 | |
| Principal Investigator: Dimitri A. Breems, MD | |
| Universitair Ziekenhuis Gent | Recruiting |
| Gent, Belgium, 9000 | |
| Principal Investigator: Lucien Noens, MD | |
| CHU de Mont-Godinne | Recruiting |
| Yvoir, Belgium, 5530 | |
| Principal Investigator: Carlos Graux, MD | |
| France | |
| CHU Angers Service de Medecine D - Maladies du Sang | Recruiting |
| Angers, France, 49033 | |
| Principal Investigator: Mathilde Hunault, MD | |
| CHU Avignon Centre Hospitalier Henri Dufaut | Recruiting |
| Avignon, France, 84000 | |
| Principal Investigator: Borhane Slama, MD | |
| Hôpital Avicenne Hématologie Clinique | Recruiting |
| Bobigny, France, 93009 | |
| Principal Investigator: Pierre Fenaux, MD, PhD | |
| CHU Caen Hématologie Clinique | Recruiting |
| Caen, France, 14000 | |
| Principal Investigator: Stéphane Cheze, MD | |
| CHU Estaing Service d'hématologie | Recruiting |
| Clermont-Ferrand, France, 63000 | |
| Principal Investigator: Benoit De Renzis, MD | |
| CHU Lille Hôpital Claude Huriez | Recruiting |
| Lille, France, 59037 | |
| Principal Investigator: Bruno Quesnel, MD | |
| CHU Limoges Hopital Dupuytren | Recruiting |
| Limoges, France, 87042 | |
| Principal Investigator: Dominique Bordessoule, MD, PhD | |
| Institute Paoli Calmettes | Recruiting |
| Marseille, France, 13009 | |
| Principal Investigator: Thomas Prebet, MD | |
| Hôpital de L'archet I | Recruiting |
| Nice, France, 6202 | |
| Principal Investigator: Laurence Legros, MD | |
| Hôtel Dieu Sce Hématologie Clinique | Recruiting |
| Paris, France, 75004 | |
| Principal Investigator: François Dreyfus, MD | |
| Hôpital Saint-Antoine | Recruiting |
| Paris, France, 75571 | |
| Principal Investigator: Ollivier Legrand, MD | |
| CHU Perpignan Centre Hospitalier Hôpital Saint-Jean | Recruiting |
| Perpignan, France, 66046 | |
| Principal Investigator: Laurence Sanhes, MD | |
| CRLCC Henri Becquerel | Recruiting |
| Rouen, France, 76038 | |
| Principal Investigator: Aspasia Stamatoullas-Bastard, MD | |
| Chu-Strasbourg-Hopital Civil | Recruiting |
| Strasbourg, France, 67091 | |
| Principal Investigator: Shanti Natarajan-Ame, MD | |
| Hôpital Purpan | Recruiting |
| Toulouse, France, 31059 | |
| Principal Investigator: Odile Beyne-Rauzy, MD | |
| Germany | |
| Universitätsklinikum Bonn | Recruiting |
| Bonn, Nordrhein-westfalen, Germany, 53127 | |
| Principal Investigator: Peter Brossart, MD | |
| Universitätsklinikum Dresden | Recruiting |
| Dresden, Germany, 01307 | |
| Principal Investigator: Uwe Platzbecker, MD | |
| Heinrich-Heine-Universität Düsseldorf | Recruiting |
| Düsseldorf, Germany, 40225 | |
| Principal Investigator: Ulrich Germing, MD | |
| Klinikum der Johann Wolfgang-Goethe-Universität | Recruiting |
| Frankfurt am Main, Germany, 60590 | |
| Principal Investigator: Oliver Ottmann, MD | |
| Universitätsklinikum Hamburg-Eppendorf | Recruiting |
| Hamburg, Germany, 20246 | |
| Principal Investigator: Philippe Schafhausen, MD | |
| Universitätsklinikum zu Köln | Recruiting |
| Köln, Germany, 50924 | |
| Principal Investigator: Karl-Anton Kreuzer, MD, PhD | |
| Universitätsmedizin Mannheim | Recruiting |
| Mannheim, Germany, 68167 | |
| Principal Investigator: Wolf-Karsten Hofmann, MD | |
| Johannes-Wesling-Klinikum Minden | Recruiting |
| Minden, Germany, 32429 | |
| Principal Investigator: Martin Griesshammer, MD | |
| Klinikum Rechts der Isar der Technischen Universität München | Recruiting |
| München, Germany, 81675 | |
| Principal Investigator: Katharina Goetze, MD | |
| Universitätsklinikum Ulm | Recruiting |
| Ulm, Germany, 89081 | |
| Principal Investigator: Richard Schlenk, MD | |
| Italy | |
| Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte | Recruiting |
| Siena, SI, Italy, 53100 | |
| Principal Investigator: Monica Bocchia, MD | |
| Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo | Recruiting |
| Alessandria, Italy, 15100 | |
| Principal Investigator: Flavia Salvi, MD | |
| Azienda Ospedaliero-Universitaria di Bologa Policlinico S. Orsola-Malpighi | Recruiting |
| Bologna, Italy, 40138 | |
| Principal Investigator: Michele Baccarani, MD | |
| Azienda Ospedaliera-Universitairia Vittorio Emanuele-Ferrarotto-Santo Bambino | Recruiting |
| Catania, Italy, 95124 | |
| Principal Investigator: Francesco Di Raimondo, MD | |
| Azienda Ospedaliera Universitaria Careggi di Firenze | Recruiting |
| Firenze, Italy, 50134 | |
| Principal Investigator: Valeria Santini, MD | |
| Azienda Ospedaliera Universitaria San Martino | Recruiting |
| Genova, Italy, 16132 | |
| Principal Investigator: Marco Gobbi, MD | |
| Azienda Osperdaliera Universitaria Maggiore della Carità | Recruiting |
| Novara, Italy, 28100 | |
| Principal Investigator: Gianluca Gaidano, MD | |
| Università degli Studi La Sapienza | Recruiting |
| Roma, Italy, 00161 | |
| Principal Investigator: Giuliana Alimena, MD | |
| Azienda Ospedaliero Universitaria San Giovanni Battista di Torino | Recruiting |
| Torino, Italy, 10126 | |
| Principal Investigator: Bernardino Allione, MD | |
| Spain | |
| Hospital Universitario Central de Asturias | Recruiting |
| Oviedo, Asturias, Spain, 33006 | |
| Principal Investigator: Teresa Bernal, MD | |
| Hospital Universitario La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Principal Investigator: Raquel de Paz, MD | |
| Hospital Universitario La Princesa | Recruiting |
| Madrid, Spain, 28006 | |
| Principal Investigator: Valle Gomez Garcia de Soria, MD | |
| Hospital Clínico Universitario Virgen de la Victoria | Recruiting |
| Málaga, Spain, 29010 | |
| Principal Investigator: Ana Isabel Rosell Mas, MD | |
| Hospital Universitario Son Espases | Recruiting |
| Palma de Mallorca, Spain, 07012 | |
| Principal Investigator: Antonia Sampol, MD | |
| Hospital Clínico Universitario de Salamanca | Recruiting |
| Salamanca, Spain, 37007 | |
| Principal Investigator: Maria Consuelo del Cañizo, MD | |
| Hospital Universitari i Politècnic La Fe | Recruiting |
| Valencia, Spain, 46009 | |
| Principal Investigator: Guillermo Sanz Santillana, MD | |
| Hospital Clínico Universitario de Valencia | Recruiting |
| Valencia, Spain, 46010 | |
| Principal Investigator: Mar Tormo, MD | |
Sponsors and Collaborators
Onconova Therapeutics, Inc.
The Leukemia and Lymphoma Society
Investigators
| Study Director: | Francois E. Wilhelm, MD, PhD | Onconova Therapeutics, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Onconova Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01241500 History of Changes |
| Other Study ID Numbers: | 04-21 |
| Study First Received: | November 1, 2010 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Onconova Therapeutics, Inc.:
|
Myelodysplastic syndromes MDS |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Preleukemia Leukemia, Myelomonocytic, Acute Neoplasms by Histologic Type |
Neoplasms Leukemia, Myeloid Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
ClinicalTrials.gov processed this record on June 18, 2013