1 |
NCT02619071 |
Recruiting |
ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia |
|
- Procedure: Tumor sampling
- Biological: Constiutional DNA sampling
|
Interventional |
Not Applicable |
- Institut Paoli-Calmettes
- Cancer Research Center of Marseille
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- The proportion of patients for whom a treatment tailored according to chemogenomic data could be proposed to the investigator within a 21 days time-frame in at least 30% of cases.
- Correlations between genomic alterations (identified by mutatome and transcriptome analyses) and drug sensitivity profiles
|
87 |
All |
18 Years and older (Adult, Senior) |
NCT02619071 |
CeGAL-IPC-2014-012 |
CeGAL |
August 2015 |
August 2017 |
August 2017 |
December 2, 2015 |
June 28, 2016 |
|
- Institut PAOLI-CALMETTES
Marseille, France
|
2 |
NCT02682732 |
Recruiting |
Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia |
|
- Procedure: FDG-PET/CT guided bone marrow sampling
|
Interventional |
Not Applicable |
- Hamilton Health Sciences Corporation
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy
- Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT02682732 |
NIF-15378 |
|
April 2016 |
December 2019 |
December 2020 |
February 15, 2016 |
February 22, 2018 |
|
- Juravinski Hospital and Cancer Center
Hamilton, Ontario, Canada
|
3 |
NCT02848001 |
Recruiting |
A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia |
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose- limiting toxicity (DLT)
- Non-tolerated dose (NTD)
- Maximum tolerated dose (MTD)
- (and 7 more...)
|
78 |
All |
18 Years and older (Adult, Senior) |
NCT02848001 |
CC-90009-AML-001 |
|
November 14, 2016 |
August 5, 2019 |
June 21, 2021 |
July 28, 2016 |
March 29, 2018 |
|
- City of Hope
Duarte, California, United States - Yale Cancer Center
New Haven, Connecticut, United States - Northwestern Memorial
Chicago, Illinois, United States - (and 16 more...)
|
4 |
NCT02984995 |
Active, not recruiting |
Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation |
|
|
Interventional |
Phase 2 |
- Daiichi Sankyo Co., Ltd.
- Daiichi Sankyo, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite complete remission (CRc) rate
- Number of participants achieving best response
- Percentage of participants achieving best response
- (and 8 more...)
|
41 |
All |
20 Years and older (Adult, Senior) |
NCT02984995 |
AC220-A-J201 JAPIC CTI-163441 |
|
December 2016 |
April 2018 |
March 2019 |
December 7, 2016 |
April 23, 2018 |
|
- Aichi, Japan
- Akita, Japan
- Chiba, Japan
- (and 24 more...)
|
5 |
NCT02348489 |
Active, not recruiting |
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction |
|
- Drug: SGI-110 (guadecitabine)
- Drug: Treatment Choice
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete response (CR)
- Overall survival
- Composite CR
- (and 5 more...)
|
815 |
All |
18 Years and older (Adult, Senior) |
NCT02348489 |
SGI-110-04 |
|
March 2015 |
June 2018 |
June 2018 |
January 28, 2015 |
December 27, 2017 |
|
- Mayo Clinic Cancer Center
Scottsdale, Arizona, United States - Scripps Cancer Center
La Jolla, California, United States - University of Southern California
Los Angeles, California, United States - (and 132 more...)
|
6 |
NCT02677922 |
Recruiting |
A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) |
|
- Drug: AG-120
- Drug: Azacitidine
- Drug: AG-221
|
Interventional |
Phase 1 Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose limiting toxicities (DLTs)-Phase 1B
- Adverse Events (AEs) in Ph 1b
- Pharmacokinetics- Cmax
- (and 18 more...)
|
127 |
All |
18 Years and older (Adult, Senior) |
NCT02677922 |
AG-221-AML-005 |
|
June 3, 2016 |
December 15, 2018 |
January 28, 2019 |
February 9, 2016 |
March 27, 2018 |
|
- City of Hope
Duarte, California, United States - Yale Cancer Center
New Haven, Connecticut, United States - Northwestern University
Chicago, Illinois, United States - (and 63 more...)
|
7 |
NCT03388749 |
Not yet recruiting |
Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) |
|
- Drug: Liposomal Annamycin
|
Interventional |
Phase 1 Phase 2 |
|
Industry |
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose-limiting Toxicity
- Pharmacokinetics - Area under the plasma concentration
- Anti-leukemic activity
|
57 |
All |
18 Years and older (Adult, Senior) |
NCT03388749 |
MB-105 |
|
January 2018 |
July 2019 |
July 2019 |
January 3, 2018 |
January 3, 2018 |
|
|
8 |
NCT03315039 |
Recruiting |
Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) |
|
- Drug: Liposomal Annamycin
|
Interventional |
Phase 1 Phase 2 |
|
Industry |
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose-limiting Toxicity
- Pharmacokinetics - Area under the plasma concentration
- Anti-leukemic activity
|
33 |
All |
18 Years and older (Adult, Senior) |
NCT03315039 |
MB-104 |
|
March 28, 2018 |
July 2019 |
July 2019 |
October 19, 2017 |
April 17, 2018 |
|
- University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
|
9 |
NCT01565668 |
Completed |
Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia |
|
|
Interventional |
Phase 2 |
- Daiichi Sankyo, Inc.
- Ambit Biosciences Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite Complete Response (CRc)
- Grade 2 or higher QT interval corrected for heart rate using Fridericia's factor (QTcF) prolongation at each dose level AC220
- Complete Remission (CR)
- (and 7 more...)
|
76 |
All |
18 Years and older (Adult, Senior) |
NCT01565668 |
2689-CL-2004 2011-005408-13 |
|
April 2012 |
March 2015 |
March 2015 |
March 29, 2012 |
April 10, 2017 |
|
- UCLA School of Medicine
Los Angeles, California, United States - Northwestern University
Chicago, Illinois, United States - University of Chicago
Chicago, Illinois, United States - (and 21 more...)
|
10 |
NCT02450877 |
Recruiting |
A Study of Safety, Efficacy and Pharmacodynamics of Azacitidine in Children and Young Adults With Acute Myeloid Leukemia. |
|
- Drug: Azacitidine
- Other: Control Arm
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse Events (AEs)
- Dose-limiting toxicities (DLTs)
- Progression-free rate at Day 84 post randomization
- (and 16 more...)
|
80 |
All |
3 Months to 21 Years (Child, Adult) |
NCT02450877 |
AZA-AML-004 |
|
August 12, 2015 |
November 2, 2018 |
October 28, 2019 |
May 21, 2015 |
April 2, 2018 |
|
- Rigshospitalet
Copenhagen, Denmark - Charite Berlin
Berlin, Germany - Universitatsklinikum Essen
Essen, Germany - (and 5 more...)
|
11 |
NCT03287128 |
Recruiting |
Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg® |
|
- Drug: Gemtuzumab Ozogamicin (GO)
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi).
- Overall survival defined as the time from onset of GO re-treatment for relapsed/refractory AML to the date of death.
- Duration of second remission
- (and 5 more...)
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT03287128 |
P1612_MYLOR |
MYLOR |
November 1, 2017 |
October 1, 2018 |
March 1, 2019 |
September 19, 2017 |
January 24, 2018 |
|
- C.H.U. d'Amiens - Hôpital Sud
Amiens, France - C.H.U. d'Angers
Angers, France - HIA Percy
Clamart, France - (and 8 more...)
|
12 |
NCT03416179 |
Recruiting |
A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia |
|
- Drug: glasdegib
- Drug: daunorubicin + cytarabine
- Drug: azacitidine
- (and 3 more...)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Overall survival
- Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire
- Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)
- (and 17 more...)
|
720 |
All |
18 Years and older (Adult, Senior) |
NCT03416179 |
B1371019 2017-002822-19 BRIGHT BRIGHT AML1019 |
BRIGHT AML1019 |
April 20, 2018 |
January 23, 2023 |
February 28, 2025 |
January 31, 2018 |
April 18, 2018 |
|
- University of Fukui Hospital
Yoshida-gun, Fukui, Japan - Gunma University Hospital
Maebashi, Gunma, Japan - Kobe University Hospital
Kobe-shi, Hyogo, Japan - (and 6 more...)
|
13 |
NCT03127735 |
Recruiting |
BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML) |
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD) or RP2D of BAY1436032
- Number of participants with Adverse Events as a Measure of
- Objective efficacy response
- (and 9 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT03127735 |
19036 2016-004095-22 |
|
June 14, 2017 |
August 31, 2019 |
October 11, 2019 |
April 25, 2017 |
March 30, 2018 |
|
- University of Southern California Keck School of Medicine
Los Angeles, California, United States - University of Florida-Gainesville
Gainesville, Florida, United States - Northside Hospital - Atlanta
Atlanta, Georgia, United States - (and 17 more...)
|
14 |
NCT01757535 |
Active, not recruiting |
Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission |
|
- Drug: 300 mg Oral Azacitidine
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Overall Survival (OS)
- Relapse free survival (RFS)
- Complete Remission (CR)/Complete Remission with incomplete blood count recovery (CRi)
- (and 3 more...)
|
472 |
All |
55 Years and older (Adult, Senior) |
NCT01757535 |
CC-486-AML-001 2012-003457-28 |
QUAZAR AML-001 |
April 24, 2013 |
January 31, 2019 |
April 30, 2019 |
December 31, 2012 |
April 11, 2018 |
|
- Arizona Oncology Associates, P.C.
Phoenix, Arizona, United States - Providence St Joseph Medical Center Cancer Center
Burbank, California, United States - City of Hope
Duarte, California, United States - (and 217 more...)
|
15 |
NCT03298516 |
Recruiting |
A Study of DCLL9718S in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Participants With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy |
|
- Drug: DCLL9718S
- Drug: Azacitidine
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of participants With Adverse Events (AEs)
- Percentage of Participants With Dose-Limiting Toxicities (DLTs)
- MTD of DCLL9718S
- (and 14 more...)
|
110 |
All |
18 Years and older (Adult, Senior) |
NCT03298516 |
GO39902 |
|
November 15, 2017 |
September 30, 2023 |
September 30, 2023 |
October 2, 2017 |
April 2, 2018 |
|
- City of Hope
Duarte, California, United States - University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States - Yale School of Medicine
New Haven, Connecticut, United States - Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749
New York, New York, United States
|
16 |
NCT01390337 |
Completed |
A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) |
|
- Drug: AC220
- Drug: daunorubicin
- Drug: cytarabine
|
Interventional |
Phase 1 |
- Daiichi Sankyo, Inc.
- Ambit Biosciences Corporation
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety assessed by recording adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and laboratory assessments
- Incidence of Dose Limiting Toxicity (DLT)
- Pharmacokinetic assessment through analysis of blood samples
|
19 |
All |
18 Years to 60 Years (Adult) |
NCT01390337 |
2689-CL-0005 |
|
October 2011 |
February 2015 |
February 2015 |
July 11, 2011 |
November 2, 2015 |
|
- Mayo Clinic Jacksonville
Jacksonville, Florida, United States - Northwestern University
Chicago, Illinois, United States - Johns Hopkins Medical Institute
Baltimore, Maryland, United States - (and 2 more...)
|
17 |
NCT02632721 |
Recruiting |
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) |
|
- Drug: Decitabine
- Drug: BI 836858
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I: Number of patients with dose limiting toxicity (DLT(s)) during first treatment cycle
- Phase II:Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi)
- Phase I: MTD of BI 836858 in combination with decitabine
- (and 5 more...)
|
150 |
All |
18 Years and older (Adult, Senior) |
NCT02632721 |
1315.2 2015-002892-30 |
|
June 16, 2016 |
January 12, 2020 |
January 12, 2020 |
December 17, 2015 |
April 17, 2018 |
|
- Mayo Clinic Cancer Center
Jacksonville, Florida, United States - Northwestern University
Chicago, Illinois, United States - Northwell Health
Lake Success, New York, United States - (and 11 more...)
|
18 |
NCT01468467 |
Completed |
A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML) |
|
|
Interventional |
Phase 1 |
- Daiichi Sankyo, Inc.
- Ambit Biosciences Corporation
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of dose limiting toxicity (DLT)
- Safety assessed by recording adverse events, physical examinations, vital signs, electrocardiograms (ECGs) and laboratory assessments
- Duration of confirmed complete remission (CR)
- (and 8 more...)
|
13 |
All |
18 Years and older (Adult, Senior) |
NCT01468467 |
2689-CL-0011 |
|
April 2012 |
March 2015 |
March 2015 |
November 9, 2011 |
December 2, 2016 |
|
- City of Hope
Duarte, California, United States - Northwestern University
Chicago, Illinois, United States - University of Minnesota
Minneapolis, Minnesota, United States - (and 2 more...)
|
19 |
NCT02545283 |
Recruiting |
A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) |
|
- Drug: Cytarabine
- Drug: Idasanutlin
- Other: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Overall Survival in TP53 WT Population
- Overall Survival in the Overall Population
- Percentage of Participants in CR at the End of Induction According to Hematologic Malignancy Response Assessment (HMRA) in TP53 WT Population
- (and 23 more...)
|
440 |
All |
18 Years and older (Adult, Senior) |
NCT02545283 |
WO29519 2014-003065-15 |
MIRROS |
December 30, 2015 |
January 26, 2019 |
June 5, 2019 |
September 9, 2015 |
April 23, 2018 |
|
- Northwell Health
Great Neck, New York, United States - New York Medical College
Hawthorne, New York, United States - Ichan School of Medicine at Mount Sinai
New York, New York, United States - (and 96 more...)
|
20 |
NCT00224614 |
Unknown † |
Randomised Prospective Comparison of the NMA Allograft and the Traditional Allograft in Acute Myeloid Leukaemia |
|
- Procedure: Allogenic transplantation
|
Interventional |
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- To show that NMA graft reduces mortality related to the procedure to 10%, compared to 30% waited in the arm of reference (α : 5%; p: 80%; bilateral formulation), 50 patients will be included in each arm
- 1- global survival, without relapse, and the various complications of the graft at 2 years 2- quality of life 3- the cost. 4- kinetics of the chimerism donor/receiver and his predictive value of the relapse and the reaction of the graft against the host.
|
100 |
All |
35 Years to 55 Years (Adult) |
NCT00224614 |
P040420 AOM04088 |
|
July 2005 |
|
July 2009 |
September 23, 2005 |
December 14, 2005 |
|
- Henri Mondor Hospital
Créteil, Val de Marne, France
|
21 |
NCT02781467 |
Terminated |
A Safety Study of Human Cord Blood Derived, Culture Expanded Natural Killer Cell (PNK-007) Infusion With Subcutaneous Recombinant Human IL-2 (rhIL-2) in Adults With Relapsed and/or Refractory Acute Myeloid Leukemia (AML) |
|
- Biological: PNK-007
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Human recombinant Interleukin-2 (rhIL-2)
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose-Limiting Toxicity (DLT)
- Maximum Tolerated Dose (MTD)
- Adverse Events (AEs)
- (and 2 more...)
|
10 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02781467 |
CCT-PNK-007-AML-001 |
|
July 11, 2016 |
December 7, 2017 |
December 7, 2017 |
May 24, 2016 |
March 1, 2018 |
|
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States - University of Minnesota
Minneapolis, Minnesota, United States - John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States - (and 4 more...)
|
22 |
NCT02670044 |
Recruiting |
A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients Aged >/= 60 Years With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy |
|
- Drug: Cobimetinib
- Drug: Idasanutlin
- Drug: Venetoclax
|
Interventional |
Phase 1 Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase Ib: Number of Participants with Dose Limiting Toxicities (DLTs)
- Phase Ib: Number of Participants with Adverse Events, Including Adverse Events of Special Interest and Serious Adverse Events
- Phase Ib: Number of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Physical Exam Findings, Electrocardiograms (ECGs) and Clinical Laboratory
- (and 24 more...)
|
140 |
All |
60 Years and older (Adult, Senior) |
NCT02670044 |
GH29914 2015-003386-28 |
|
March 31, 2016 |
January 15, 2020 |
January 15, 2020 |
February 1, 2016 |
April 17, 2018 |
|
- USC Norris Cancer Center
Los Angeles, California, United States - UC Davis; Comprehensive Cancer Center
Sacramento, California, United States - Univ of Calif, San Francisco
San Francisco, California, United States - (and 16 more...)
|
23 |
NCT02003573 |
Terminated |
Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML) |
|
- Drug: decitabine iv
- Drug: volasertib iv infusion
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1
- Maximum Tolerated Dose (MTD) in Cycle 1
|
127 |
All |
65 Years and older (Adult, Senior) |
NCT02003573 |
1230.30 2013-001752-36 |
|
January 2014 |
November 2016 |
November 2016 |
December 6, 2013 |
December 15, 2016 |
|
- Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States - Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States - Boehringer Ingelheim Investigational Site
Lake Success, New York, United States - Boehringer Ingelheim Investigational Site
Houston, Texas, United States
|
24 |
NCT02722135 |
Withdrawn |
A Study to Find a Safe Dose of Volasertib Given in Addition to Standard Salvage Chemotherapy in Children (Age 3 Months to Less Than 18 Years) With Acute Myeloid Leukaemia, in Whom Front-line Chemotherapy Failed |
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determination of the maximal tolerated dose of volasertib or the recommended volasertib dose for further studies in combination with standard salvage therapy in paediatric patients with AML after failure of the front-line intensive chemotherapy regimen
- Anti-leukaemic activity of volasertib in combination with standard salvage therapy
- Event-free survival (EFS)
- (and 7 more...)
|
0 |
All |
3 Months to 17 Years (Child) |
NCT02722135 |
1230.28 2015-004625-14 |
|
November 2016 |
May 2018 |
September 2018 |
March 29, 2016 |
January 27, 2017 |
|
- Boehringer Ingelheim Investigational Site
Gent, Belgium
|
25 |
NCT01662505 |
Completed |
Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML) |
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determination of the maximum tolerated dose based on the incidence of dose limiting toxicities
- Complete remission (CR)
- Complete remission with incomplete blood count recovery (CRi)
- Partial remission (PR)
|
19 |
All |
18 Years and older (Adult, Senior) |
NCT01662505 |
1230.26 |
|
August 2012 |
May 2015 |
May 2015 |
August 10, 2012 |
July 31, 2015 |
|
- 1230.26.002 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan - 1230.26.003 Boehringer Ingelheim Investigational Site
Isehara, Kanagawa, Japan - 1230.26.005 Boehringer Ingelheim Investigational Site
Maebashi, Gunma,, Japan - (and 3 more...)
|
26 |
NCT02140606 |
Unknown † |
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML) |
|
- Drug: Cafusertib Hydrochloride
|
Interventional |
Phase 1 |
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities
- Efficacy (complete remission, CR; complete remission with incomplete blood count recovery, Cri; Partial remission (PR))
- Incidence and intensity of adverse events graded according to CTCAE (version 4.0)
- (and 2 more...)
|
|
All |
18 Years and older (Adult, Senior) |
NCT02140606 |
HS-10159-I-01 |
|
May 2014 |
December 2015 |
|
May 16, 2014 |
May 16, 2014 |
|
- Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Tianjin, China
|
27 |
NCT00129948 |
Terminated |
Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) |
|
- Drug: Troxatyl™ (troxacitabine)
|
Interventional |
Phase 2 |
- SGX Pharmaceuticals, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine complete response (CR) rate
- To determine the complete response with incomplete platelet recovery (CRp) rate, and recurrent disease (RD) rates
- Efficacy and safety, preliminary evidence of the anti-tumor activity, determination of Troxatyl™ infusion pharmacokinetic parameters
|
211 |
All |
18 Years and older (Adult, Senior) |
NCT00129948 |
SPD758-216 |
|
July 2005 |
|
October 2007 |
August 12, 2005 |
November 3, 2006 |
|
- Scripps Clinic
LaJolla, California, United States - USC-Norris Neuro-Oncology Program
Los Angeles, California, United States - UCSD Moores Cancer Center
San Diego, California, United States - (and 17 more...)
|
28 |
NCT01518556 |
Recruiting |
Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia |
|
|
Interventional |
Phase 1 Phase 2 |
- Konkuk University Medical Center
- Chung-Ang University Hosptial, Chung-Ang University College of Medicine
- Seoul National University Hospital
- (and 6 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of idarubicin in the phase I study.
- Complete remission rate in the phase II study.
- Dose-limiting toxicity in the phase I study.
- Event-free survival and overall survival in the phase II study.
|
67 |
All |
20 Years to 65 Years (Adult) |
NCT01518556 |
AML-2011-01 |
IDAML |
July 2011 |
June 2019 |
December 2019 |
January 26, 2012 |
March 13, 2018 |
|
- Division of Hematology-Oncology, Konkuk University Medical Center
Seoul, Korea, Republic of
|
29 |
NCT01632852 |
Completed |
A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission |
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Frequency and Severity of Adverse Events (AEs)
- Dose-limiting toxicity (DLT) evaluation
- Pharmacokinetic (PK) Parameters
- Number of subjects developing antibodies against CSL362
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01632852 |
CSLCT-AML-11-73 |
|
July 2012 |
August 2015 |
|
July 3, 2012 |
October 9, 2015 |
|
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School
Chicago, Illinois, United States - Sidney Kimmel Cancer Center at Johns Hopkins
Baltimore, Maryland, United States - Weill Cornell Medical College
New York, New York, United States - (and 2 more...)
|
30 |
NCT01016600 |
Completed Has Results |
Azacitidine and Lenalidomide for Acute Myeloid Leukemia |
|
- Drug: Lenalidomide
- Drug: Azacitidine
|
Interventional |
Phase 1 Phase 2 |
- Washington University School of Medicine
- Celgene Corporation
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)
- Phase I Only - Maximum Tolerated Dose (MTD)
- Phase II Only - Complete Remission Rate (CRm + CRi) in Participants With Untreated AML ≥60 Years of Age
- (and 12 more...)
|
31 |
All |
18 Years and older (Adult, Senior) |
NCT01016600 |
09-1816 / 201101749 |
|
April 2010 |
November 2013 |
October 2014 |
November 19, 2009 |
September 7, 2015 |
September 7, 2015 |
- Washington University School of Medicine
St. Louis, Missouri, United States
|
31 |
NCT01246752 |
Unknown † |
Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) <= 60y. After First CR |
|
- Biological: Human Stem Cell Transplantation
- Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
|
Interventional |
Phase 3 |
- University Hospital Carl Gustav Carus
- German Research Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent of Patients alive after 4 years (Overall Survival)
- Disease-free survival
- Cumulative incidence of relapse
- (and 2 more...)
|
356 |
All |
18 Years to 60 Years (Adult) |
NCT01246752 |
TUD-ETAL-1-045 |
AML |
November 2010 |
December 2017 |
December 2017 |
November 23, 2010 |
December 3, 2014 |
|
- Universitätsklinikum Aachen
Aachen, Germany - Klinikum Augsburg
Augsburg, Germany - Bielefeld Klinikum Mitte
Bielefeld, Germany - (and 24 more...)
|
32 |
NCT00727766 |
Completed |
Oral Clofarabine for Acute Myeloid Leukemia |
|
|
Interventional |
Phase 1 |
- Washington University School of Medicine
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD) and dose limiting toxicity (DLT)
- Adverse events by grade and attribution
- Disease-free survival
- Overall survival
|
25 |
All |
60 Years and older (Adult, Senior) |
NCT00727766 |
08-0853 / 201108049 |
|
January 2009 |
September 2012 |
November 2014 |
August 4, 2008 |
November 11, 2014 |
|
- Washington University
St. Louis, Missouri, United States
|
33 |
NCT01690624 |
Active, not recruiting |
BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients in Complete Remission With High Risk to Relapse |
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determination of the maximum tolerated dose of BI 836858
- Number of patients with dose limiting toxicity during maximum tolerated dose evaluation for patients with refractory or relapsed acute myeloid leukemia
- Number of patients with dose limiting toxicity during maximum tolerated dose evaluation for acute myeloid leukemia patients in complete remission with high risk to relapse
- (and 16 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01690624 |
1315.1 |
|
September 13, 2012 |
April 27, 2018 |
May 31, 2018 |
September 24, 2012 |
April 24, 2018 |
|
- Northwestern University
Chicago, Illinois, United States - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States - Washington University School of Medicine
Saint Louis, Missouri, United States - (and 2 more...)
|
34 |
NCT01721876 |
Active, not recruiting |
Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2) |
|
- Drug: placebo
- Drug: volasertib
- Drug: low dose cytarabine
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Complete Remission (CR)
- Complete remission with incomplete blood count recovery (CRi)
- Overall survival (OS)
- (and 2 more...)
|
666 |
All |
Child, Adult, Senior |
NCT01721876 |
1230.14 2012-002487-27 |
|
January 29, 2013 |
August 12, 2014 |
December 31, 2019 |
November 6, 2012 |
April 13, 2018 |
|
- University of California
Los Angeles, California, United States - St. Luke's Hospital Association of Duluth, Inc.
Duluth, Minnesota, United States - Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States - (and 119 more...)
|
35 |
NCT00906945 |
Completed Has Results |
Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia |
|
- Drug: G-CSF
- Drug: Plerixafor
- Drug: Mitoxantrone
- (and 2 more...)
|
Interventional |
Phase 1 Phase 2 |
- Washington University School of Medicine
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC
- Phase II: Complete Response Rate (CR+CRi)
- Phase I and Phase II: Safety and Tolerability of Regimen as Measured by Grade and Frequency of Adverse Events Exceeding 10% in Total Frequency
- (and 9 more...)
|
39 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00906945 |
10-0910 / 201106039 |
|
February 2011 |
November 2012 |
September 2015 |
May 21, 2009 |
April 4, 2017 |
April 4, 2017 |
- Dana Farber Cancer Institute
Boston, Massachusetts, United States - Washington University
St. Louis, Missouri, United States - MD Anderson Cancer Center
Houston, Texas, United States
|
36 |
NCT01001143 |
Completed |
Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML) |
|
- Drug: Decitabine
- Drug: Bexarotene
|
Interventional |
Phase 1 |
- Washington University School of Medicine
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Toxicity of combination decitabine and bexarotene during four cycles of therapy
- To determine the complete remission (CR) and partial remission (PR) rate after four cycles of therapy.
- To determine the rates of hematological improvement, transfusion independence, time to progression, cytogenetic response, and survival.
- (and 4 more...)
|
19 |
All |
18 Years and older (Adult, Senior) |
NCT01001143 |
09-1661 / 201012801 |
AML |
May 2010 |
May 2013 |
May 2014 |
October 23, 2009 |
July 29, 2014 |
|
- Washington University School of Medicine
St. Louis, Missouri, United States
|
37 |
NCT01027923 |
Terminated |
IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML) |
|
- Drug: Plerixafor
- Drug: Mitoxantrone
- Drug: Etoposide
- Drug: Cytarabine
|
Interventional |
Phase 1 |
- Washington University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the maximum tolerated dose and dose limiting toxicities of intravenous plerixafor when combined with MEC in patients with relapsed or refractory AML.
- To determine the complete response rate (CR) for plerixafor when combined with MEC in patients with relapsed or refractory AML.
- To determine the safety and tolerability of plerixafor in combination with MEC
- (and 8 more...)
|
6 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01027923 |
09-1825 / 201101703 |
AML |
May 2010 |
July 2010 |
September 2011 |
December 9, 2009 |
January 26, 2015 |
|
- Washington University School of Medicine
St. Louis, Missouri, United States
|
38 |
NCT00850304 |
Completed |
Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide |
|
- Drug: Cytosar
- Drug: Arsenic trioxide
|
Interventional |
Phase 2 |
- Tehran University of Medical Sciences
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response Rate
- Overall Survival
|
10 |
All |
60 Years and older (Adult, Senior) |
NCT00850304 |
87-02-36-7242 |
|
October 2007 |
February 2008 |
February 2008 |
February 24, 2009 |
February 24, 2009 |
|
- Hematology-Oncology and SCT Research Center
Tehran, Iran, Islamic Republic of
|
39 |
NCT02928523 |
Active, not recruiting |
PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment |
|
- Drug: Autologous Fecal Microbiota Transplantation
|
Interventional |
Phase 1 Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of AFMT efficacy in dysbiosis correction by measure of microbiota diversity
- Evaluation of AFMT efficacy in MDRB eradication based on bacterial culture
- Definition of a dysbiosis biosignature using combination of biological parameters
|
20 |
All |
18 Years to 65 Years (Adult) |
NCT02928523 |
MPOH02 |
ODYSSEE |
June 2016 |
September 2017 |
June 2018 |
October 10, 2016 |
November 21, 2017 |
|
- IPC
Marseille, France - CHU Nantes
Nantes, France - Hopital Saint Antoine
Paris, France - HCL Lyon Sud
Pierre Benite, France
|
40 |
NCT00546897 |
Completed Has Results |
Lenalidomide in Older Patients With Acute Myeloid Leukemia Without Chromosome 5q Abnormalities |
|
|
Interventional |
Phase 2 |
- Washington University School of Medicine
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete Remission Rate (CRm + CRi + CRc)
- Safety and Tolerability (Removal From Study Due to Adverse Events)
- Response Rate (RR)
- (and 13 more...)
|
48 |
All |
60 Years and older (Adult, Senior) |
NCT00546897 |
06-0907 |
|
February 2007 |
June 2010 |
March 2012 |
October 19, 2007 |
September 29, 2014 |
September 29, 2014 |
- Washington University School of Medicine
St. Louis, Missouri, United States
|
41 |
NCT00804856 |
Active, not recruiting |
Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia |
|
- Drug: BI 6727 (d1 and 15)
- Drug: Cytarabine
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I part: MTD of BI 6727 monotherapy and BI 6727 in combination with LDAraC
- Phase IIa part: Efficacy (complete remission, CR; complete remission with incomplete blood count recovery, CRi)
- Incidence and intensity of adverse events graded according to CTCAE (version 3.0)
- (and 13 more...)
|
180 |
All |
18 Years and older (Adult, Senior) |
NCT00804856 |
1230.4 2008-003617-27 |
|
November 27, 2008 |
March 9, 2012 |
July 11, 2018 |
December 9, 2008 |
March 9, 2018 |
|
- LKH-Univ. Klinikum Graz
Graz, Austria - AZ Sint-Jan Brugge
Brugge, Belgium - Brussels - UNIV St-Luc
Bruxelles, Belgium - (and 24 more...)
|
42 |
NCT02715011 |
Recruiting |
Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) |
|
|
Interventional |
Phase 1 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Part 1: Number of subjects with dose-limiting toxicity (DLT)
- Part 1: Type of dose-limiting toxicity (DLT)
- Part 2: Occurence of adverse events and serious adverse events
- (and 10 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02715011 |
CR108147 63709178AML1001 2016-000208-27 |
|
June 1, 2016 |
October 29, 2020 |
October 29, 2020 |
March 22, 2016 |
March 30, 2018 |
|
- University of Colorado
Aurora, Colorado, United States - University of Maryland
Baltimore, Maryland, United States - Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States - (and 13 more...)
|
43 |
NCT00701766 |
Completed |
BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia |
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
|
- Maximum tolerated dose Best objective response
- Event free survival, Overall survival, Remission duration, BI 2536 plasma concentrations, Incidence and intensity of adverse events graded according to CTCAE, PD, Incidence of DLT
|
71 |
All |
60 Years and older (Adult, Senior) |
NCT00701766 |
1216.20 EudraCT No:2006-000613-38 |
|
October 2006 |
October 2009 |
|
June 19, 2008 |
May 16, 2014 |
|
- 1216.20.43001 Boehringer Ingelheim Investigational Site
Innsbruck, Austria - 1216.20.43002 Boehringer Ingelheim Investigational Site
Wien, Austria - 1216.20.49006 Boehringer Ingelheim Investigational Site
Bonn, Germany - (and 6 more...)
|
44 |
NCT02809092 |
Recruiting |
Interleukin-21 (IL-21)- Expanded Natural Killer Cells for Induction of Acute Myeloid Leukemia |
|
- Biological: NK Cells + Chemotherapy Starting
|
Interventional |
Phase 1 Phase 2 |
- Hospital de Clinicas de Porto Alegre
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of membrane-bound interleukin 21 (mbIL21)-Expanded Haploidentical NK Cells After Induction Chemotherapy with Fludarabine, Cytarabine, and Granulocyte-colony stimulating factor (G-CSF).
- Complete Remission (CR) Assessment Following Infusion of the NK Cells
- Donor NK-Cell Expansion
|
30 |
All |
2 Years to 59 Years (Child, Adult) |
NCT02809092 |
10-0457 |
|
April 1, 2017 |
December 2018 |
September 2020 |
June 22, 2016 |
November 27, 2017 |
|
- Centro Terapia e Tecnologia Celular
Porto Alegre, Rio Grande Do Sul, Brazil
|
45 |
NCT02860793 |
Completed |
Role of PTK-7 in Acute Myeloid Leukemias |
|
- Other: Bone marrow aspiration
- Other: Blood sampling
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Evaluation PTK7+ and PTK7- AML cells hematopoietic homing abilities in xenografted mice by in vivo bioluminescence imaging
- Soluble PTK7 measurement in the serum
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT02860793 |
LAM-PTK7-IPC 2013-011 |
LAM-PTK7 |
January 2014 |
April 2015 |
|
August 9, 2016 |
August 10, 2016 |
|
- Institut Paoli Calmettes
Marseille, Bouches du Rhone, France
|
46 |
NCT02319135 |
Recruiting |
Azacytidine (Vidaza®) Versus Fludarabine and Cytarabine (Fluga Scheme) in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia |
|
- Drug: Azacitadine
- Drug: Fludarabine
- Drug: Cytarabine
- (and 2 more...)
|
Interventional |
Phase 3 |
- PETHEMA Foundation
- Dynamic Solutions
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy (overall survival (OS) attained without increasing the therapy-related toxicity or decreasing the patients QoL.
- Efficacy (Event free survival (EFS)
- Efficacy (Duration of remission.)
- (and 2 more...)
|
350 |
All |
65 Years and older (Adult, Senior) |
NCT02319135 |
FLUGAZA |
FLUGAZA |
October 2014 |
October 2018 |
October 2019 |
December 18, 2014 |
March 20, 2018 |
|
- Hospital Universitari i Politècnic La Fe
Valencia, Spain
|
47 |
NCT02920008 |
Recruiting |
Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia |
|
- Drug: guadecitabine
- Drug: Treatment Choice (TC)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Event-free survival
- Long-term survival
- (and 9 more...)
|
404 |
All |
18 Years and older (Adult, Senior) |
NCT02920008 |
SGI-110-06 |
|
March 16, 2017 |
April 2019 |
June 2019 |
September 30, 2016 |
March 16, 2018 |
|
- The University of Arizona Cancer Center
Tucson, Arizona, United States - University of Southern California
Los Angeles, California, United States - The University of Chicago Medical Center
Chicago, Illinois, United States - (and 89 more...)
|
48 |
NCT02975869 |
Recruiting |
A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia |
|
- Other: Standard Leukemia Care
- Other: Palliative Care
|
Interventional |
Not Applicable |
- Massachusetts General Hospital
- Duke University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Comparison Of The Change In Patients' FACT-Leukemia Score From Baseline To Week-2 Between Study Arms
- Compare Change In FACT-Leukemia Scores From Baseline To Months 1, 3, And 6, And Longitudinally Between The Study Arms.
- Compare Rates of Patients' Depressive Symptoms (as per HADS), and Major Depressive Syndrome (as per PHQ-9) at Baseline, Week-2, Months 1, 3, and 6, and Longitudinally Between the Two Arms
- (and 8 more...)
|
160 |
All |
60 Years and older (Adult, Senior) |
NCT02975869 |
16-439 |
|
September 2016 |
December 2019 |
December 2021 |
November 29, 2016 |
August 16, 2017 |
|
- Massachusetts general Hospital
Boston, Massachusetts, United States - Duke University
Durham, North Carolina, United States - University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
49 |
NCT01961765 |
Completed |
Phase I Trial of Cabozantinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia |
- Relapsed Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
|
|
Interventional |
Phase 1 |
- Massachusetts General Hospital
- Exelixis
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD) of cabozantinib in patients with advanced acute myeloid leukemia
- Number of patients with adverse events including grade 3/4 adverse events
- Response rate
- (and 4 more...)
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT01961765 |
13-363 |
|
November 2013 |
May 2016 |
January 2017 |
October 11, 2013 |
July 21, 2017 |
|
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States - Massachusetts General Hospital
Boston, Massachusetts, United States
|
50 |
NCT01889407 |
Unknown † |
Idarubicin Overcomes MDR1 Induced Chemoresistance With Higher Induction Remission Rate and Quality Than Daunorubicin in Acute Myeloid Leukemia Patients |
|
|
Observational |
|
- Nanfang Hospital of Southern Medical University
- Pfizer
|
Other / Industry |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- complete remission rate
- WT1 and MDR1 expression level change after 2 courses of chemotherapy with IA regimen or DA regimen in high-MDR1 expression AML patients.
|
94 |
All |
14 Years to 60 Years (Child, Adult) |
NCT01889407 |
IDA20130517 |
|
August 2013 |
July 2016 |
July 2016 |
June 28, 2013 |
April 21, 2015 |
|
- Bing Xu
GuangZhou, Guangdong, China
|