ClinicalTrials.gov

History of Changes for Study: NCT03504410
Study Evaluating Efficacy and Safety of CPI-613 in Combination With HD Cytarabine and Mitoxantrone Compared to HD Cytarabine and Mitoxantrone and Control Sub-groups: MEC and FLAG in Older Patients With R/R AML
Latest version (submitted July 16, 2020) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 19, 2018 None (earliest Version on record)
2 April 19, 2018 Arms and Interventions, Outcome Measures and Study Status
3 September 7, 2018 Study Status and Arms and Interventions
4 October 18, 2018 Arms and Interventions, Study Status, Outcome Measures, Eligibility and Study Identification
5 November 15, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
6 November 19, 2018 Contacts/Locations and Study Status
7 January 13, 2019 Study Status and Study Identification
8 January 14, 2019 Study Status and Study Identification
9 April 8, 2019 Contacts/Locations and Study Status
10 May 1, 2019 Study Status and Contacts/Locations
11 May 7, 2019 Contacts/Locations and Study Status
12 June 10, 2019 Study Status and Contacts/Locations
13 July 8, 2019 Study Status and Contacts/Locations
14 July 29, 2019 Contacts/Locations and Study Status
15 July 31, 2019 Contacts/Locations and Study Status
16 August 2, 2019 Study Status and Contacts/Locations
17 August 11, 2019 Contacts/Locations and Study Status
18 August 21, 2019 Contacts/Locations and Study Status
19 August 30, 2019 Contacts/Locations and Study Status
20 September 2, 2019 Study Status and Contacts/Locations
21 September 5, 2019 Contacts/Locations and Study Status
22 September 13, 2019 Contacts/Locations and Study Status
23 October 1, 2019 Study Status and Contacts/Locations
24 October 2, 2019 Contacts/Locations and Study Status
25 October 10, 2019 Contacts/Locations and Study Status
26 October 24, 2019 Contacts/Locations and Study Status
27 January 23, 2020 Contacts/Locations and Study Status
28 February 7, 2020 Contacts/Locations, Eligibility, Outcome Measures, Study Status, Study Description and Study Identification
29 April 19, 2020 Contacts/Locations and Study Status
30 May 21, 2020 Arms and Interventions, Study Identification, Contacts/Locations, Eligibility, Study Description and Study Status
31 July 16, 2020 Study Status and Contacts/Locations
Comparison Format:

Scroll up to access the controls

Changes (Merged) for Study: NCT03504410
April 19, 2020 (v29) -- May 21, 2020 (v30)

Changes in: Arms and Interventions, Study Identification, Contacts/Locations, Eligibility, Study Description and Study Status

Study Identification
Unique Protocol ID: AML003
Brief Title: Study Evaluating Efficacy and Safety of CPI-613 in Combination With HD Cytarabine and Mitoxantrone vs Compared to HD Cytarabine and Mitoxantrone and Control Sub-groups: MEC and FLAG in Older Patients With R/R AML
Official Title: Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613® (Devimistat) in Combination With High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) Therapy and Control Sub-groups: Combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and Combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in Older Patients (≥ 50 Years) With Relapsed/Refractory Acute Myeloid Leukemia (AML)
Secondary IDs:
Study Status
Record Verification: February 2020
Overall Status: Recruiting
Study Start: November 12, 2018
Primary Completion: October 2022 [Anticipated]
Study Completion: March 2023 [Anticipated]
First Submitted: April 12, 2018
First Submitted that
Met QC Criteria:
April 19, 2018
First Posted: April 20, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
April 19 May 21, 2020
Last Update Posted: April 21 May 26, 2020 [Actual]
Sponsor/Collaborators
Sponsor: Rafael Pharmaceuticals Inc.
Responsible Party: Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Study Description
Brief Summary: A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups.
Detailed Description:
Conditions
Conditions: Relapsed/Refractory Acute Myeloid Leukemia
Keywords:
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 500 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Experimental: CPI-613 + HD Cytarabine and Mitoxantrone

CPI-613 + High Dose Cytarabine and Mitoxantrone

CPI-613 at 2,000 mg/m2/day from day 1 to 5.

Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 2nd and 5th doses of Cytarabine.

Drug: CPI-613 + High Dose Cytarabine and Mitoxantrone
CPI-613 + High Dose Cytarabine and Mitoxantrone CPI-613: 2000mg/m2, 5 doses once a day, days 1-5 Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine
Other Names:
  • CPI-613, CHAM
Active Comparator: HD Cytarabine and Mitoxantrone Active Comparator: Control (HAM) and control sub-groups (MEC and FLAG)

High Dose Cytarabine and Mitoxantrone

Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 3rd and 5th doses of Cytarabine.

Mitoxantrone, Etoposide and Cytarabine

Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6

Fludarabine, Cytarabine and Filgrastim

Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5

Drug: High Dose Cytarabine and Mitoxantrone
Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine
Other Names:
  • HAM
Drug: Mitoxantrone, Etoposide and Cytarabine

Mitoxantrone, Etoposide and Cytarabine

Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6

Other Names:
  • MEC
Drug: Fludarabine, Cytarabine, Filgrastim

Fludarabine, Cytarabine and Filgrastim

Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5

Other Names:
  • FLAG
Outcome Measures
Primary Outcome Measures:
1. Complete Remission (CR)
Complete disappearance of all clinical evidence of disease

[Time Frame: 8 months]
Secondary Outcome Measures:
2. Overall Survival (OS)
the duration from the date of randomization to the date of death from any cause

[Time Frame: 12 months]
3. CR+CRh
Complete Remission + CR with partial hematological recovery (CRh)

[Time Frame: 12 months]
Eligibility
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

INCLUSION CRITERIA:

  1. Patient has provided an informed consent prior to initiation of any study specific activities/procedures .
  2. Males and females age ≥ 50 years must have histologically documented AML that is relapsed from, or refractory to, prior standard therapies .
  3. Refractory is defined as failure to achieve CR or CRi following:
    1. Two standard dose Cytarabine based induction cycles or one HiDAC based cycle or, At least one cycle of any anthracycline, cytarabine or fludarabine containing induction regimen or persistence of disease on a nadir marrow following at least one cycle of any anthracycline, cytarabine or fludarabine containing induction regimen
    2. Persistent disease after one cycle of standard dose cytarabine (defined as no decrease in marrow blast percentage from diagnosis on Day 14 marrow) or,
    3. Persistent disease after at least 2 cycles of a hypomethylating agent (azacytidine or decitabine) with or without venetoclax
  4. Relapse is defined as development of recurrent AML (as described by Döhner et al, 2017)6 after CR or CRi has been achieved with a prior chemotherapy or after disease progression on a hypomethylating agent with or without venetoclax .
  5. ECOG PS 0-2
  6. Expected survival greater than 3 months .
  7. Women of child-bearing potential (i.e. women who are pre-menopausal or < 2 years post menopausal or not surgically sterile) must practice a highly effective method of birth control consistent with local regulations regarding the use of birth control methods. Examples: use of oral, injected or implanted hormonal methods of contraception; placement of an intra uterine device (IUD) or intrauterine system (IUS); male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence during and for 6 months after the last administered dose of CHAM or HAM therapy and control sub-groups (MEC and FLAG), and must have a negative serum pregnancy test within 1 week prior to treatment initiation and at 1st day of each cycle and at the end of systemic exposure. (Note: pregnant patients are excluded because the effects of CPI-613® (devimistat) on a fetus are unknown) .
  8. Fertile men who are sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository during the study period and up to 6 months after completion of the study screening, unless documentation of infertility exists .
  9. Good state of mental health, ability to understand and willingness to sign the informed consent form (ICF) .
  10. No radiotherapy, treatment with cytotoxic chemotherapy, treatment with biologic agents or any anti-cancer therapy for R/R AML within the 1 week prior to treatment with CPI-613® (devimistat). Hydroxyurea and/or venetoclax and oral tyrosine kinase (FLT3) or Isocitrate Dehydrogenase 1 and 2 (IDH1/2), BCL-2 or hedgehog inhibitors being used with Grade ≤ 2 toxicity can be taken until the day prior to starting study of CHAM or HAM therapy or control sub-groups (MEC and FLAG). Previous exposure to a hypomethylating agent either alone or in combination with Venetoclax is Isocitrate Dehydrogenase 1 and 2 (IDH1/2), BCL-2 or hedgehog inhibitors are allowed until the day prior to starting of CHAM or HAM therapy and control sub-groups (MEC and FLAG). Patients must have fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities with the exception of alopecia (returned to baseline status as noted before most recent treatment). Patients with persisting, non-hematologic, non-infectious toxicities from prior treatment Grade ≤ 2 are eligible but must be documented as such
  11. Laboratory values ≤ 2 weeks before dosing must be:
    • Adequate hepatic function (aspartate aminotransferase/serum glutamic-oxaloacetic transaminase [AST/SGOT] ≤ 5 x upper limit of normal [ULN], alanine aminotransferase/serum glutamic oxaloacetic transaminase [ALT/SGPT] ≤ 5 × ULN, bilirubin ≤ 1.5 × ULN) .
    • Adequate renal function (serum creatinine clearance ≥ 60 mL/min per CockCroft Gault formula) .
    • Adequate coagulation (International Normalized Ratio [INR] must be < 1.7 unless on vitamin k antagonist anticoagulation) .
  12. Left Ventricular Ejection Fraction (LVEF) by Transthoracic Echocardiogram (TTE) or Multigated Acquisition Scan (MUGA) or cardiac Magnetic Resonance Imaging (MRI), sufficient to safely administer mitoxantrone. Subjects must have an LVEF ≥ 45% .
  13. No marked baseline prolongation of QT/QTc interval (repeated exhibition of a QTc interval > 450 480 ms for both male and > 470 ms for female patients) .
  14. No history of additional risk factors for torsade de pointes (e.g. clinically significant heart failure, hypokalemia, immediate family history of Long QT Syndrome) .
  15. Allow only patients who experienced relapse after 1 year from previous HiDAC treatment or who didn't receive HiDAC previously (Note: This inclusion applies only to South Korea) .

EXCLUSION CRITERIA:

  1. Patients who have received cytotoxic chemotherapy treatment for their current relapsed or refractory AML. (Treatment with hypomethylating agents (decitabine or azacytidine) either alone or in combination with venetoclax is are allowed until the day prior to starting of CHAM or HAM therapy and control sub-groups (MEC and FLAG). Targeted therapies including FLT3 or IDH1/2 inhibitors and/or Hydrea and/or venetoclax are allowed. Targeted therapies and Hydrea may be taken until the day prior to starting CHAM or HAM therapy or control sub-groups (MEC and FLAG)
  2. Vulnerable adult and patient whose health conditions does not allow them to give their consent
  3. History or evidence of any other clinically significant disorder, condition or disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, symptomatic myocardial infection, uncontrolled cardiac arrhythmia, pericardial disease or heart failure New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity and in the opinion of the Investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures or completion
  4. Patients with active Central Nervous System (CNS) involvement (leukemic infiltration, blast in the spinal fluid)
  5. Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g. active peptic ulcer disease)
  6. Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of CHAM or HAM therapy or control sub-groups, MEC and FLAG (the teratogenic potential of CPI-613® (devimistat) is unknown). Female patients of childbearing potential with a positive pregnancy test assessed by a serum pregnancy test at Screening .
  7. Women of childbearing potential (i.e. women who are pre-menopausal or < 2 years postmenopausal or not surgically sterile) unwilling to practice a highly effective method of birth control consistent with local regulations regarding the use of birth control methods during treatment and for 6 months after completion of CHAM or HAM therapy or control sub-groups, MEC and FLAG for AML
  8. Male patients with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for 6 months after completion of CHAM or HAM therapy . or control sub-groups, MEC and FLAG
  9. Male patients unwilling to abstain from donating sperm during treatment and for 6 months after completion of CHAM or HAM therapy or control sub-groups, MEC and FLAG with potential highest teratogenic risk .
  10. Known hypersensitivity to study treatment drugs or any of the excipient(s) contained in the drug formulation .
  11. Life expectancy less than 3 months .
  12. Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients .
  13. Unwilling or unable to follow protocol requirements .
  14. Patients with large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly) .
  15. Patients with any amount of clinically significant pericardial effusion that requires drainage.
  16. Evidence of ongoing, uncontrolled bacterial, viral or fungal infection .
  17. Patients with known human immunodeficiency virus infection .
  18. History of other malignancy within the past 5 years, with the following exception(s):
    1. Malignancy treated with curative intent and with no known active disease present for ≥ 5 years before enrolment and felt to be at low risk for recurrence by the treating physician
    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of recurrent or residual disease
    3. Adequately treated cervical carcinoma in situ without evidence of disease
    4. Prostate cancer Stage 1
  19. Patients receiving any other standard or investigational treatment for AML, or any other investigational agent for any indication within the past 1 week prior to initiation of CPI-613® (devimistat) treatment (the use of Hydrea and/or venetoclax, oral tyrosine kinase inhibitors FLT3 or IDH 1/2 inhibitors is are allowed until the day prior to starting CHAM or HAM therapy or control sub-groups, MEC and FLAG. Previous exposure to a hypomethylating agent either alone or in combination with venetoclax is are allowed until the day prior to starting of CHAM or HAM therapy and control sub-groups (MEC and FLAG) . )
  20. Patients who have received immunotherapy of any type within the past 1 week prior to initiation of CPI-613® (devimistat) treatment .
  21. Requirement for immediate palliative treatment of any kind including minor surgery .
  22. Patients who have received a chemotherapy regimen with autologous stem cell support (bone marrow transplantation) within 6 months . of starting CHAM or HAM therapy or control sub-groups (MEC and FLAG)
  23. Patients who have had allogenic bone marrow transplantation within the last 6 months. Patients who have had an allogenic transplant more than 6 months ago are eligible provided they have no graft vs host disease. (Note: Exclude only patients with active GVHD requiring therapy with immunosuppressive agents and not patients with stable GVHD not requiring immunosuppression.)
  24. Cytarabine contraindications
    • Hypersensitivity to the cytarabine or to any of the excipients of cytarabine injection .
    • Anemia, leucopenia and thrombocytopenia of non-malignant aetiology (e.g bone marrow aplasia); unless the clinician feels that such management offers the most hopeful alternative for the patient .
    • Degenerative and toxic encephalopathies, especially after the use of methotrexate or treatment with ionizing radiation .
  25. Mitoxantrone contraindications
    • Mitoxantrone Sterile Concentrate is contraindicated in patients who have demonstrated prior hypersensitivity to mitoxantrone hydrochloride, other anthracyclines or any of its components. Use in patients with profound bone marrow suppression is a relative contraindication depending on the clinical circumstances .
    • Mitoxantrone Sterile Concentrate should not be used during pregnancy or lactation .
  26. Strong CYP450 inducers should be prohibited
  27. Etoposide contraindications

    •. Contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products

  28. Fludarabine contraindications

    •. Contraindicated in those patients who are hypersensitive to this drug or its components

  29. Filgrastim contraindications •. Contraindicated in patients with known hypersensitivity to E coli-derived proteins, Filgrastim, or any component of the product
Contacts/Locations
Central Contact: Sanjeev Luther
Telephone: 585-978-1351
Email: sanjeev.luther@rafaelpharma.com
Study Officials: Jorge Eduardo Cortes, MD
Principal Investigator
Augusta University
Locations: United States, Arizona
Honor Health Research Institute
[Recruiting]
Scottsdale, Arizona, United States, 85258
Principal Investigator: Jeffery Schriber, MD
United States, California
Chao Family Comprehensive Cancer Center (University of California Irvine)
[Recruiting]
Orange, California, United States, 92868
Principal Investigator: Deepa Jeyakumar, MD
California Pacific Medical Center
[Recruiting]
San Francisco, California, United States, 94115
Principal Investigator: Ari Baron, MD
United States, Illinois
Northwestern Memorial Hospital
[Recruiting]
Chicago, Illinois, United States, 60611
Principal Investigator: Olga Frankfurt, MD
University of Chicago
[Recruiting]
Chicago, Illinois, United States, 60637
Principal Investigator: Richard A Larson, MD
Loyola University Medical Center
[Recruiting]
Maywood, Illinois, United States, 60153
Principal Investigator: Patrick Stiff, MD
United States, Iowa
University of Iowa-Holden Cancer Care Center
[Recruiting]
Iowa City, Iowa, United States, 52242
Principal Investigator: Carlos V Gonzales, MD
United States, Kentucky
University of Kentucky
[Recruiting]
Lexington, Kentucky, United States, 40436
Principal Investigator: Gerhard Hildebrandt, MD
Norton Cancer Institute
[Recruiting]
Louisville, Kentucky, United States, 40207
Principal Investigator: Joseph Maly, MD
United States, New Jersey
Atlantic Health System
[Recruiting]
Morristown, New Jersey, United States, 07960
Principal Investigator: Mohamad Cherry, MD
Rutgers Cancer Institute of New Jersey
[Recruiting]
New Brunswick, New Jersey, United States, 08901
Principal Investigator: Athena Kritharis, MD
United States, New York
Stony Brook University Hospital
[Recruiting]
Long Island City, New York, United States, 11794
Principal Investigator: Michael Schuster, MD
Memorial Sloan Kettering Cancer Center
[Recruiting]
New York, New York, United States, 10065
Principal Investigator: Martin Tallman, MD
United States, North Carolina
UNC Chapel Hill
[Recruiting]
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Matthew Foster, MD
Wake Forest Baptist Health
[Recruiting]
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Bayard L Powell, MD
United States, Ohio
University of Cincinnati
[Recruiting]
Cincinnati, Ohio, United States, 45219
Principal Investigator: Zartash Gul, MD
Cleveland Clinic
[Recruiting]
Cleveland, Ohio, United States, 44195
Principal Investigator: Aziz Nazha, MD
United States, Oregon
Oregon Health & Science University
[Recruiting]
Portland, Oregon, United States, 97239
Principal Investigator: Rachel Cook, MD
United States, Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center
[Recruiting]
Dallas, Texas, United States, 75246
Principal Investigator: Moshe Levy, MD
University of Texas - Southwestern Medical Center
[Recruiting]
Dallas, Texas, United States, 75390
Principal Investigator: Prapti Patel, MD
Baylor Temple (BSW)
[Recruiting]
Temple, Texas, United States, 76508
Principal Investigator: Vinit Karur, MD
United States, Virginia
University of Virginia
[Recruiting]
Charlottesville, Virginia, United States, 22908
Principal Investigator: Michael Keng, MD
Australia, New South Wales
Border Medical Oncology Research Unit
[Recruiting]
Albury, New South Wales, Australia, 2640
Principal Investigator: Richard Eek, MD
Gosford Hospital
[Recruiting]
Gosford, New South Wales, Australia, 2250
Principal Investigator: Tasman Armytage, MD
Calvary Mater Newcastle Hospital
[Recruiting]
Waratah, New South Wales, Australia, 2298
Principal Investigator: Anoop Enjeti, MD
Australia, Western Australia
Royal Perth Hospital
[Recruiting]
Perth, Western Australia, Australia, 6000
Principal Investigator: Peter Tan, MD
Austria
Universitätsklinik für Innere Medizin
[Recruiting]
Graz, Austria, 8036
Principal Investigator: Heinz Sill
Paracelsus Medical University
[Recruiting]
Salzburg, Austria, 5020
Principal Investigator: Richard Greil
Hanuschkrankenhaus der WGKK
[Recruiting]
Wien, Austria, 1140
Principal Investigator: Elisabeth Koller, MD
Belgium
Algemeen Ziekenhuis Sint-Jan
[Recruiting]
Brugge, Belgium, 8000
Principal Investigator: Dominik Selleslag, MD
Clinique Universitaire St Luc
[Recruiting]
Brussels, Belgium, 1200
Principal Investigator: Violaine Havelange, MD
UN Gent
[Recruiting]
Gent, Belgium, 9000
Principal Investigator: Ine Moors, MD
France, Yvelines
Centre Hospitalier de Versailles - Hôpital André Mignot
[Recruiting]
Le Chesnay, Yvelines, France, 78157
Principal Investigator: Phillippe Rousselot, MD
France
CHU Amiens
[Recruiting]
Amiens, France, 80054
Principal Investigator: Lebon Delphine, MD
Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris
[Recruiting]
Bobigny, France, 9300
Principal Investigator: Thorsten Braun, MD
CHU de Caen
[Recruiting]
Caen, France, 14033
Principal Investigator: Sylvain Chantepie, MD
Centre Hospitalier Universitaire Grenoble Hopital Michalon
[Recruiting]
Grenoble Cedex 9, France, 38043
Principal Investigator: Claude Eric Bulabois, MD
CHU la Conecption
[Recruiting]
Marseille, France, 13005
Principal Investigator: Regis Costello, MD
CHU de Nice
[Recruiting]
Nice, France, 06202
Principal Investigator: Thomas Cluzeau, MD
Hopital Saint Louis
[Recruiting]
Paris, France, 75010
Principal Investigator: Raphael Itzykson, MD
Centre hospitalier Lyon Sud
[Recruiting]
Pierre-Bénite, France, 69495
Principal Investigator: Xavier Thomas, MD
Germany
Universitatsklinikum Marburg
[Recruiting]
Marburg, Germany, 35033
Principal Investigator: Andreas Neubauer, MD
Robert-Bosch- Krankenhaus
[Recruiting]
Stuttgart, Germany, 70376
Principal Investigator: Martin Kaufmann, MD
Korea, Republic of
Seoul National University Hospital
[Recruiting]
Seoul, Korea, Republic of, 03080
Principal Investigator: Sung-Soo Yoon
Severance Hospital
[Recruiting]
Seoul, Korea, Republic of, 03722
Principal Investigator: June-Won Cheong, MD
Asan Medical Center
[Recruiting]
Seoul, Korea, Republic of, 05505
Principal Investigator: Eunji Choi, MD
Samsung Medical Center
[Recruiting]
Seoul, Korea, Republic of, 06351
Principal Investigator: Jun Ho Jang, MD
Poland
Zespół Szpitali Miejskich w Chorzowie
[Recruiting]
Chorzów, Poland, 41500
Principal Investigator: Sebastian Grosicki, MD
Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii
[Recruiting]
Gdańsk, Poland, 80211
Principal Investigator: Ewa Zarzycka, MD
Spain
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol
[Recruiting]
Badalona, Spain, 08916
Principal Investigator: Susana Vives Polo, MD
Hospital Vall d'Hebron
[Recruiting]
Barcelona, Spain, 08035
Principal Investigator: Olga Salamero
Hospital Son ESPASES
[Recruiting]
Palma De Mallorca, Spain, 07120
Principal Investigator: Antonia Sampol, MD
Hospital Clínico Universitario de Salamanca
[Recruiting]
Salamanca, Spain, 37007
Principal Investigator: Maria Belen Vidriales Vicente, MD
Hospital U. P. La Fe
[Recruiting]
Valencia, Spain, 46026
Principal Investigator: Pau Montesinos, MD
IPDSharing
Plan to Share IPD: Undecided
References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services