1 |
NCT02841540 |
Recruiting |
Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia |
- Myelodysplastic Syndromes
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
|
|
Interventional |
Phase 1 |
- H3 Biomedicine Inc.
- Eisai Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Dose-limiting Toxicities (DLTs) as a function of the dose of H3B-8800 for determination of the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
- Number of participants with any treatment-emergent adverse event (TEAE) and serious adverse event (SAE)
- Mean area under the plasma concentration-time curve from time 0 through the last measurable point (AUC0-t)
- (and 11 more...)
|
110 |
All |
18 Years and older (Adult, Senior) |
NCT02841540 |
H3B-8800-G000-101 2016-001792-70 |
|
August 2016 |
December 2018 |
March 2019 |
July 22, 2016 |
November 22, 2017 |
|
- Stanford Cancer Center
Stanford, California, United States - Colorado Blood Cancer Institute
Denver, Colorado, United States - Mayo Clinic
Jacksonville, Florida, United States - (and 12 more...)
|
2 |
NCT01904643 |
Recruiting |
Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
- Adult Acute Megakaryoblastic Leukemia (M7)
- Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
- Adult Acute Monoblastic Leukemia (M5a)
- (and 12 more...)
|
- Drug: lenalidomide
- Drug: mitoxantrone hydrochloride
- Drug: etoposide
- Drug: cytarabine
|
Interventional |
Phase 1 |
- Stanford University
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MTD of lenalidomide when used in combination with MEC determined by DLT using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
- Response rate (complete remission [CR], CR with incomplete blood count recovery [CRi], partial remission [PR] or stable disease [SD]) using LeukemiaNet guidelines
- Response duration
- Early mortality
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01904643 |
HEMAML0024 NCI-2013-01349 27313 P30CA124435 |
|
February 2014 |
December 31, 2018 |
July 31, 2019 |
July 22, 2013 |
January 11, 2018 |
|
- Stanford University, School of Medicine
Stanford, California, United States
|
3 |
NCT02071901 |
Recruiting |
Eltrombopag Olamine in Improving Platelet Recovery in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy |
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
- Adult Acute Basophilic Leukemia
- Adult Acute Eosinophilic Leukemia
- (and 16 more...)
|
- Drug: eltrombopag olamine
|
Interventional |
Phase 2 |
- Case Comprehensive Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Patients with a median platelet count >= 50,000/uL
- Median time needed to reach platelet count >= 50,000 /µL
- Number of days of platelet transfusions
- (and 10 more...)
|
31 |
All |
60 Years and older (Adult, Senior) |
NCT02071901 |
CASE4913 NCI-2014-00252 P30CA043703 |
|
August 14, 2014 |
October 2018 |
October 2018 |
February 26, 2014 |
April 18, 2018 |
|
- Case Comprehensive Cancer Center
Cleveland, Ohio, United States
|
4 |
NCT02019069 |
Recruiting |
CPX-351 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome |
- Adult Acute Erythroid Leukemia (M6)
- Adult Acute Megakaryoblastic Leukemia (M7)
- Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
- (and 13 more...)
|
- Drug: liposomal cytarabine-daunorubicin CPX-351
- Other: laboratory biomarker analysis
|
Interventional |
Phase 2 |
- Bruno C. Medeiros
- National Cancer Institute (NCI)
- Stanford University
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of mortality assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Incidence of mortality assessed using the CTCAE version 4.0
- Incidence of serious adverse events as assessed by CTCAE version 4.0
- (and 5 more...)
|
33 |
All |
60 Years and older (Adult, Senior) |
NCT02019069 |
HEM0036 NCI-2013-01982 4593 P30CA124435 28524 |
|
February 2014 |
July 2019 |
December 2019 |
December 24, 2013 |
June 14, 2017 |
|
- Stanford University, School of Medicine
Stanford, California, United States
|
5 |
NCT03268954 |
Recruiting |
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) |
- Myelodysplastic Syndrome
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myeloid, Acute
|
- Drug: Azacitidine
- Drug: Pevonedistat
|
Interventional |
Phase 3 |
- Millennium Pharmaceuticals, Inc.
- Takeda
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants with Overall Response by Cycle 6
- Event-Free Survival (EFS)
- Overall Survival
- (and 26 more...)
|
450 |
All |
18 Years and older (Adult, Senior) |
NCT03268954 |
Pevonedistat-3001 2017-000318-40 U1111-1189-8055 MOH_2018-02-04_002154 JapicCTI-183848 |
PANTHER |
November 28, 2017 |
April 30, 2020 |
February 28, 2023 |
August 31, 2017 |
March 26, 2018 |
|
- Southern Cancer Center
Daphne, Alabama, United States - Southern Cancer Center
Mobile, Alabama, United States - Southern Cancer Center
Mobile, Alabama, United States - (and 202 more...)
|
6 |
NCT03146871 |
Recruiting |
Recombinant EphB4-HSA Fusion Protein and Azacitidine or Decitabine for Relapsed or Refractory Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Patients Previously Treated With a Hypomethylating Agent |
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Chronic Myelomonocytic Leukemia
- Previously Treated Myelodysplastic Syndrome
- (and 2 more...)
|
- Drug: Azacitidine
- Drug: Decitabine
- Other: Laboratory Biomarker Analysis
- (and 2 more...)
|
Interventional |
Phase 2 |
- University of Southern California
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
- Overall response defined as the occurrence of complete response, marrow complete response, partial response, or hematological improvement assessed by the IWG Working Group Criteria for MDS and AML
- Time to death from any cause
- (and 2 more...)
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT03146871 |
9L-16-6 NCI-2017-00623 P30CA014089 |
|
April 20, 2017 |
April 20, 2020 |
April 20, 2021 |
May 10, 2017 |
August 22, 2017 |
|
- USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
|
7 |
NCT03289910 |
Not yet recruiting |
Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia |
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
- (and 7 more...)
|
- Drug: Carboplatin
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- (and 3 more...)
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Overall response defined as complete response/complete response with incomplete recovery
- Incidence of toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- Distribution of mutations in deoxyribonucleic acid (DNA) repair defects via assessment in Leukemia mutation panel
- (and 2 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT03289910 |
NCI-2017-01715 10147 UM1CA186691 |
|
May 18, 2018 |
June 30, 2019 |
June 30, 2019 |
September 21, 2017 |
April 13, 2018 |
|
|
8 |
NCT02367456 |
Recruiting |
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients |
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
|
- Drug: PF-04449913 (Glasdegib)
- Drug: Azacitidine
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete remission (CR) rate
- Adverse events (Safety lead-in phase)
- Response Rate
- (and 26 more...)
|
72 |
All |
18 Years and older (Adult, Senior) |
NCT02367456 |
B1371012 2014-001345-24 |
BRIGHT 1012 |
April 28, 2015 |
November 7, 2019 |
November 6, 2021 |
February 20, 2015 |
February 28, 2018 |
|
- University of Alabama at Birmingham the Kirklin Clinic
Birmingham, Alabama, United States - University of Alabama at Birmingham
Birmingham, Alabama, United States - Drug Shipment Address: University of Alabama at Birmingham
Birmingham, Alabama, United States - (and 24 more...)
|
9 |
NCT02190695 |
Recruiting |
Leukemia SPORE Phase II 3-arm DAC Randomized Study for R/R and Elderly Acute AML and MDS |
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Chronic Myelomonocytic Leukemia
|
- Drug: Decitabine
- Drug: Carboplatin
- Drug: Arsenic trioxide
|
Interventional |
Phase 2 |
- Temple University
- M.D. Anderson Cancer Center
- TEVA
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to complete or partial remission
|
130 |
All |
18 Years and older (Adult, Senior) |
NCT02190695 |
21357 |
|
April 2013 |
April 2018 |
April 2018 |
July 15, 2014 |
April 27, 2017 |
|
- Temple BMT Program at Jeanes Hospital
Philadelphia, Pennsylvania, United States - M.D. Anderson Cancer Center
Houston, Texas, United States
|
10 |
NCT02749708 |
Recruiting |
Study of IRX5183 in Relapsed and Refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome |
- Acute Myeloid Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
- Chronic Myelomonocytic Leukemia (CMML)
|
|
Interventional |
Phase 1 Phase 2 |
- Sidney Kimmel Comprehensive Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluate safety and tolerability of IRX5183 in phase I using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0, to determine dose limiting toxicities (DLTs) and the recommended phase 2 dose (RP2D).
- Determine the best overall response rate (ORR) per International Working Group (IWG) criteria with the RP2D after at least 2 therapy cycles.
- Measure trough plasma levels of IRX5183 on day 1 and day 14.
- (and 8 more...)
|
40 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT02749708 |
J15219 IRB00083855 |
|
April 2016 |
December 2020 |
December 2021 |
April 25, 2016 |
March 1, 2018 |
|
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
|
11 |
NCT01305499 |
Recruiting |
A Trial to Evaluate Two Schedules of MS275 in Combination With 5AC in Elderly Patients With Acute Myeloid Leukemia (AML) |
|
- Drug: Entinostat days 3, 10
- Drug: 5AC
- Drug: Entinostat days 10,17
|
Interventional |
Phase 2 |
- Case Comprehensive Cancer Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To estimate the major response rate in patients with AML who are ≥ 60 years old and unable to tolerate or decline cytotoxic chemotherapy or patients who have relapsed despite one prior regimen.
- To estimate the overall response rate following treatment in patients with AML ≥ 60 years old who are unable to tolerate or decline cytotoxic chemotherapy or those who have relapsed despite one prior regimen.
- To identify changes in gene promoter methylation and gene expression in response to combination therapy and compare the dynamics and kinetics of these alterations in promoter methylation and gene re-expression in the two different dosing schedules.
- (and 4 more...)
|
108 |
All |
60 Years and older (Adult, Senior) |
NCT01305499 |
CASE2914 J1093 |
|
July 1, 2011 |
September 2018 |
February 2019 |
February 28, 2011 |
February 27, 2018 |
|
- Yale School of Medicine
New Haven, Connecticut, United States - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States - Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
|
12 |
NCT02684162 |
Recruiting |
SGI-110 With Donor Lymphocyte Infusion (DLI) for Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Relapsing Post Allogeneic Stem Cell Transplantation (AlloSCT) |
- Leukemia
- Myeloproliferative Diseases
|
- Drug: SGI-110
- Procedure: Donor Lymphocyte Infusion
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
- Astex Pharmaceuticals
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response of Participants with Hematologic Malignancies Exhibiting Minimal Residual Disease (MRD) After Allogeneic Stem Cell Transplant (Allosct) and SGI-110
- Response of Participants with Hematologic Malignancies Who Have Relapsed After Allogeneic Stem Cell Transplant (Allosct) and SGI-110
- Relapse-Free Survival With SGI-110 as Maintenance Therapy in Patients with High Risk Acute Myeloid Leukemia or Myelodysplastic Syndrome After Hematopoietic Stem Cell Transplantation
|
90 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02684162 |
2015-0117 NCI-2016-00343 |
|
June 2016 |
June 2021 |
June 2022 |
February 17, 2016 |
March 21, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
13 |
NCT02935361 |
Recruiting |
Guadecitabine and Atezolizumab in Treating Patients With Advanced Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia That Is Refractory or Relapsed |
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndrome
- Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes
|
- Drug: Atezolizumab
- Drug: Guadecitabine
|
Interventional |
Phase 1 Phase 2 |
- University of Southern California
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of dose-limiting toxicities evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
- Overall response (complete response [CR] + partial response + marrow CR + hematological improvement) (Phase II)
- Incidence of grade 3 or higher adverse events and grade 2 toxicities that do not resolve after 3 weeks assessed by CTCAE 4.0
- (and 5 more...)
|
72 |
All |
18 Years and older (Adult, Senior) |
NCT02935361 |
9L-16-3 NCI-2016-01233 P30CA014089 |
|
November 2, 2016 |
November 2, 2020 |
November 2, 2021 |
October 17, 2016 |
November 13, 2017 |
|
- USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States - University of Maryland Medical Center
Baltimore, Maryland, United States - Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States - Temple University Hospital
Philadelphia, Pennsylvania, United States
|
14 |
NCT01773395 |
Recruiting |
GVAX vs. Placebo for MDS/AML After Allo HSCT |
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
|
- Biological: GVAX
- Biological: Placebo Vaccine
- Procedure: Allogeneic Hematopoietic Stem Cell Transplant
- (and 4 more...)
|
Interventional |
Phase 2 |
- Dana-Farber Cancer Institute
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Progression Free Survival
- Safety and toxicity of vaccination, as measured by the development of grade II-IV and III-IV acute graft versus host disease, CTC grade 3 and higher non-hematologic toxicity, or grade 4 and higher hematologic toxicity attributable to vaccination
- Incidence of acute and chronic GVHD
- (and 4 more...)
|
152 |
All |
18 Years and older (Adult, Senior) |
NCT01773395 |
12-217 |
|
January 2013 |
July 2019 |
January 2033 |
January 23, 2013 |
July 21, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States - Brigham and Women's Hospital
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
15 |
NCT02061800 |
Recruiting |
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant |
- Chronic Myeloid Leukemia (CML)
- Acute Myelogenous Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
- (and 3 more...)
|
- Device: CliniMACS CD34+ Reagent System
- Drug: Thiotepa
- Drug: Cyclophosphamide
- (and 6 more...)
|
Interventional |
Phase 1 Phase 2 |
- Diane George, MD
- Columbia University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of acute GVHD
- Time to neutrophil engraftment
- Time to immune reconstitution
- (and 7 more...)
|
25 |
All |
up to 22 Years (Child, Adult) |
NCT02061800 |
AAAK8060 |
|
June 3, 2013 |
December 2018 |
December 2018 |
February 13, 2014 |
July 17, 2017 |
|
- Columbia University Medical Center
New York, New York, United States
|
16 |
NCT02663622 |
Recruiting |
A Phase II Trial of CD24Fc for Prevention of Acute Graft-versus-Host Disease Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplant |
- Acute Myeloid Leukemia (AML)
- Chronic Myelogenous Leukemia (CML)
- Myelodysplastic Syndrome (MDS)
- Chronic Myelomonocytic Leukemia (CMML)
|
- Drug: CD24Fc
- Drug: Methotrexate
- Drug: Tacrolimus
- Other: Placebo
|
Interventional |
Phase 2 |
- OncoImmune, Inc.
- Ohio State University
- University of Michigan Cancer Center
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The cumulative incidence of acute GVHD
- The cumulative incidence of relapse
- The cumulative incidence of non-relapse mortality
- (and 3 more...)
|
204 |
All |
18 Years and older (Adult, Senior) |
NCT02663622 |
UMCC 2015.181 HUM00107805 |
|
August 2016 |
June 2020 |
|
January 26, 2016 |
July 2, 2017 |
|
- Indiana University School of Medicine
Indianapolis, Indiana, United States - The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States - Karmanos Cancer Institute
Detroit, Michigan, United States - Ohio State University
Columbus, Ohio, United States
|
17 |
NCT03493646 |
Not yet recruiting New |
Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486 |
- Myelodysplastic Syndromes
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
|
- Drug: Azacitidine
- Drug: CC-486
|
Interventional |
Phase 2 |
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- DNA incorporation of Vidaza® compared to CC-486
- DNA incorporation in bone marrow mononuclear cells
- DNA AZA derivative uptake
- (and 2 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT03493646 |
2018-01-AZA VZ-CL-MDSAML-PI-13085 |
|
April 2018 |
December 2019 |
December 2021 |
April 10, 2018 |
April 10, 2018 |
|
- Calvary Mater Newcastle
Newcastle, New South Wales, Australia - Nepean Hospital
Penrith, New South Wales, Australia - Prince of Wales Hospital
Sydney, New South Wales, Australia - (and 6 more...)
|
18 |
NCT01595295 |
Recruiting |
Registry on Hypomethylating Agents in Myeloid Neoplasms |
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndromes
- Acute Myeloid Leukemia
|
- Other: non interventional
|
Observational |
|
- Arbeitsgemeinschaft medikamentoese Tumortherapie
|
Other |
- Observational Model: Other
- Time Perspective: Other
|
- Response evaluation
- Overall survival
- Documentation of adverse events and toxicities
- (and 3 more...)
|
1500 |
All |
18 Years and older (Adult, Senior) |
NCT01595295 |
AGMT_HMA Register |
|
February 2009 |
December 2018 |
December 2018 |
May 10, 2012 |
April 5, 2017 |
|
- LKH Feldkirch
Feldkirch, Austria - LKH Fürstenfeld
Fürstenfeld, Austria - UK Graz: Universitätsklinik für Innere Medizin; Klinische Abteilung für Hämatologie
Graz, Austria - (and 16 more...)
|
19 |
NCT03404726 |
Recruiting |
A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies |
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose
- Number of Adverse Events as a measure of safety and tolerability
- AUC (0-24) (Area under the curve)
- (and 5 more...)
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT03404726 |
19420 2017-002896-24 |
|
March 29, 2018 |
September 25, 2020 |
September 25, 2020 |
January 19, 2018 |
April 5, 2018 |
|
- Albert Einstein College of Medicine
Bronx, New York, United States - Memorial Sloan Kettering Cancer Center
New York, New York, United States - Thomas Jefferson University
Philadelphia, Pennsylvania, United States - (and 2 more...)
|
20 |
NCT00600860 |
Recruiting |
A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes |
- Myelodysplastic Syndromes (MDS)
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Demographics
- Correlations
- New prognostic scoring systems
- Scientific research in MDS
|
4000 |
All |
18 Years and older (Adult, Senior) |
NCT00600860 |
883 |
EUMDS |
April 2008 |
June 2020 |
December 2020 |
January 25, 2008 |
November 28, 2016 |
|
- University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology
Innsbruck, Austria - Clinical Hospital Merkur
Zagreb, Croatia - Institute of Haematology and Blood Transfusion U nemocnice
Prague, Czech Republic - (and 14 more...)
|
21 |
NCT01620216 |
Recruiting |
Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia |
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndrome
- (and 3 more...)
|
- Other: Antitumor Drug Screening Assay
- Drug: Dasatinib
- Other: Laboratory Biomarker Analysis
- (and 5 more...)
|
Interventional |
Phase 2 |
- OHSU Knight Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical activity, defined as a decrease of at least 25% in bone marrow blast counts
- Changes in transfusion requirements
- Clinical activity (defined as a decrease of at least 25% in bone marrow blast counts) in subjects who have failed the initial inhibitor but are then treated with another inhibitor identified on repeat pre-clinical activity testing
- (and 3 more...)
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT01620216 |
IRB00007195 NCI-2012-01084 CA180-392 P30CA069533 R21CA159265 |
|
May 11, 2012 |
March 30, 2019 |
March 30, 2019 |
June 15, 2012 |
April 17, 2018 |
|
- National Heart Lung and Blood Institute
Bethesda, Maryland, United States - OHSU Knight Cancer Institute
Portland, Oregon, United States - UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States - Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
|
22 |
NCT02666950 |
Recruiting |
WEE1 Inhibitor AZD1775 With or Without Cytarabine in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome |
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndrome With Isolated Del(5q)
- Myelodysplastic/Myeloproliferative Neoplasm
- (and 3 more...)
|
- Drug: Cytarabine
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- (and 3 more...)
|
Interventional |
Phase 2 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete response rate (CR or CRi) per the National Comprehensive Cancer Network (NCCN) guidelines or according to specific criteria from expert panels (Arm A)
- Complete response rate (CR or CRi) per the NCCN guidelines or according to specific criteria from expert panels (Arm B and C)
- Clinical benefit (i.e. hematological improvements, transfusion requirements)
- (and 6 more...)
|
102 |
All |
18 Years and older (Adult, Senior) |
NCT02666950 |
MC1488 NCI-2015-02136 P30CA015083 |
|
May 5, 2017 |
April 15, 2021 |
April 15, 2021 |
January 28, 2016 |
December 2, 2017 |
|
- Mayo Clinic in Arizona
Scottsdale, Arizona, United States
|
23 |
NCT03128034 |
Recruiting |
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome |
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Acute Myeloid Leukemia in Remission
- (and 5 more...)
|
- Drug: Cyclosporine
- Drug: Fludarabine Phosphate
- Other: Laboratory Biomarker Analysis
- (and 6 more...)
|
Interventional |
Phase 1 Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients who develop grades III/IV Bearman regimen-related toxicity
- Achievement of remission
- Disease-free survival
- (and 6 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03128034 |
9595 NCI-2017-00452 P01CA078902 P30CA015704 |
|
October 24, 2017 |
July 19, 2021 |
April 19, 2026 |
April 25, 2017 |
February 23, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
24 |
NCT03072043 |
Recruiting |
Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms |
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Myeloproliferative Neoplasm
- Chronic Myelomonocytic Leukemia
|
- Drug: APR-246
- Drug: Azacitidine
|
Interventional |
Phase 1 Phase 2 |
- H. Lee Moffitt Cancer Center and Research Institute
- Aprea Therapeutics AB
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase 1b: Maximum Tolerated Dose (MTD)
- Phase 2: Overall Survival (OS)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT03072043 |
MCC-18973 |
|
May 5, 2017 |
May 2020 |
May 2021 |
March 7, 2017 |
March 16, 2018 |
|
- H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States - The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
|
25 |
NCT03358719 |
Recruiting |
DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia |
- Acute Myeloid Leukemia
- Blasts 30 Percent or Less of Bone Marrow Nucleated Cells
- Chronic Myelomonocytic Leukemia
- (and 3 more...)
|
- Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401
- Drug: Decitabine
- Other: Laboratory Biomarker Analysis
- (and 2 more...)
|
Interventional |
Phase 1 |
- Roswell Park Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events
- Immune cell profile
- Peripheral blood and bone marrow cells responses
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT03358719 |
I 49217 NCI-2017-02012 P30CA016056 |
|
March 27, 2018 |
September 13, 2019 |
September 13, 2020 |
December 2, 2017 |
March 29, 2018 |
|
- Roswell Park Cancer Institute
Buffalo, New York, United States
|
26 |
NCT03175978 |
Recruiting |
IGF-MTX Conjugate in the Treatment of Myelodysplastic Syndrome |
- Myelodysplastic Syndromes
- Leukemia, Myelomonocytic, Chronic
- Anemia, Refractory, With Excess of Blasts
|
|
Interventional |
Phase 1 Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events
- Response criteria for AML, Complete Remission (CR)
- Response criteria for AML, CR with incomplete recovery
- (and 19 more...)
|
9 |
All |
18 Years and older (Adult, Senior) |
NCT03175978 |
AML-03 |
|
February 21, 2018 |
June 2020 |
September 2020 |
June 5, 2017 |
April 4, 2018 |
|
- Mayo Clinic
Rochester, Minnesota, United States - Regions Cancer Care Center
Saint Paul, Minnesota, United States
|
27 |
NCT03280888 |
Recruiting |
Relevance of Peripheral Cells in the Pathophysiology of Chronic Myelomonocytic Leukemia (CMML) |
- Chronic Myelomonocytic Leukemia
|
|
Observational |
|
- Centre Hospitalier Universitaire de Nice
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Characterization of molecular mechanisms
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03280888 |
13-PP-11 |
|
November 5, 2014 |
November 5, 2018 |
November 5, 2018 |
September 13, 2017 |
March 19, 2018 |
|
|
28 |
NCT01010256 |
Recruiting |
The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia |
- Chronic Myelomonocytic Leukemia
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
|
22 |
All |
18 Years and older (Adult, Senior) |
NCT01010256 |
111245 |
|
November 1, 2009 |
January 2020 |
January 2020 |
November 9, 2009 |
February 14, 2018 |
|
- University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
|
29 |
NCT02530476 |
Recruiting |
Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia |
- Leukemia
- Acute Myeloid Leukemia
|
- Drug: Selinexor
- Drug: Sorafenib
|
Interventional |
Phase 1 Phase 2 |
- M.D. Anderson Cancer Center
- Karyopharm Therapeutics Inc
- National Cancer Institute (NCI)
|
Other / Industry / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of Selinexor with Sorafenib
- Composite CR (CRc) Rate defined as CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) within 3 months of treatment initiation
|
52 |
All |
18 Years and older (Adult, Senior) |
NCT02530476 |
2014-0975 NCI-2015-01523 P50CA100632 |
|
December 8, 2015 |
December 2019 |
December 2020 |
August 21, 2015 |
April 17, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
30 |
NCT02546284 |
Recruiting |
Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML) |
- Chronic Myelomonocytic Leukemia (CMML)
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of lenzilumab (as measured by the number of participants with adverse events) at various doses in order to determine a recommended Phase 2 dose
- Clinical activity of lenzilumab (as measured by changes in spleen size, blood and bone marrow measurements of disease, clinical symptoms, etc)
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT02546284 |
HGEN003-05 |
|
July 2016 |
July 2018 |
October 2018 |
September 10, 2015 |
March 15, 2018 |
|
- Moffitt Cancer Center
Tampa, Florida, United States - Mayo Clinic Cancer Center Clinical Research
Rochester, Minnesota, United States
|
31 |
NCT00167219 |
Recruiting |
Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML) |
- Juvenile Myelomonocytic Leukemia
|
- Biological: Stem Cell Transplant
- Drug: Preparative Regimen
|
Interventional |
Phase 1 Phase 2 |
- Masonic Cancer Center, University of Minnesota
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine probability of long-term disease free survival in JMML
- Secondary outcome measures are the incidence of neutrophil engraftment, graft-versus-host disease (GVHD), regimen-related toxicity, and relapse.
|
20 |
All |
up to 18 Years (Child, Adult) |
NCT00167219 |
1999LS073 MT1999-20 9911M24961 |
|
November 18, 1999 |
December 2020 |
December 2020 |
September 14, 2005 |
December 5, 2017 |
|
- Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
|
32 |
NCT02807272 |
Recruiting |
Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia |
- Leukemia, Myelomonocytic, Chronic
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with CMML who obtain objective response following treatment with tipfarnib
- Number of patients with CMML whose disease is KRAS/NRAS wild type who obtain objective response following treatment with tipfarnib.
- Rate of complete response (CR)
- (and 7 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02807272 |
KO-TIP-004 |
CMML |
October 2016 |
December 2018 |
April 2019 |
June 21, 2016 |
October 12, 2017 |
|
- UC San Diego Moores Cancer Center
La Jolla, California, United States - H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, United States - Massachusetts General Hospital
Boston, Massachusetts, United States - (and 4 more...)
|
33 |
NCT03040401 |
Recruiting |
A Study of HDC/IL-2 Treatment in Chronic Myelomonocytic Leukemia (CMML) |
- Leukemia, Myelomonocytic, Chronic
|
- Drug: Cohort 1, Ceplene® and Proleukin®
- Drug: Cohort 2, Ceplene® and Proleukin®
- Drug: Cohort 3, Ceplene® and Proleukin®
|
Interventional |
Phase 1 Phase 2 |
- Vastra Gotaland Region
- Sahlgrenska University Hospital, Sweden
- Karolinska University Hospital
- Nordic MDS Group
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events as defined by CTCAE v4.03.
- Disease progression according to IWG criteria for MDS/MPN
- Percentage of blasts in peripheral blood
- (and 6 more...)
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT03040401 |
NMDSG14A |
|
February 15, 2017 |
December 15, 2018 |
December 15, 2019 |
February 2, 2017 |
December 19, 2017 |
|
- Sahlgrenska University Hospital
Gothenburg, Sweden - Karolinska University Hospital, Huddinge
Stockholm, Sweden
|
34 |
NCT03018223 |
Recruiting |
Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT |
- Non-Hodgkin's Lymphoma
- Acute Leukemia in Remission
- Chronic Myeloid Leukemia
- (and 5 more...)
|
- Drug: Fludarabine
- Drug: Busulfan
- Drug: Cyclophosphamide
- (and 5 more...)
|
Interventional |
Phase 2 |
- H. Lee Moffitt Cancer Center and Research Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Incidence of Grade II-IV Acute Graft vs. Host Disease (GVHD)
- Incidence of Chronic GVHD
- Overall Survival (OS)
- Progression Free Survival (PFS)
|
32 |
All |
18 Years and older (Adult, Senior) |
NCT03018223 |
MCC-18766 |
|
January 10, 2017 |
January 2020 |
January 2021 |
January 11, 2017 |
December 15, 2017 |
|
- H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
|
35 |
NCT02996773 |
Recruiting |
Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine |
- Acute Lymphoblastic Leukemia
- Acute Myelogenous Leukemia
- Myelodysplastic Syndromes
- (and 10 more...)
|
- Drug: Bendamustine
- Drug: Cyclophosphamide
|
Interventional |
Phase 1 Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety in regards to engraftment, incidence and grade of acute and chronic graft versus host disease and toxicity/non-relapse mortality post-haploidentical bone marrow transplantation.
- Incidence of regimen-related organ toxicities
- Severity of regimen-related organ toxicities
- (and 17 more...)
|
32 |
All |
8 Years to 65 Years (Child, Adult) |
NCT02996773 |
1609876907 |
|
November 29, 2016 |
April 2018 |
April 2018 |
December 19, 2016 |
March 15, 2018 |
|
- The University of Arizona Cancer Center
Tucson, Arizona, United States
|
36 |
NCT02193958 |
Recruiting |
Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies |
|
|
Interventional |
Phase 1 Phase 2 |
- Fujifilm Pharmaceuticals U.S.A., Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety
- Determination of overall response rates.
- Evaluate the pharmacokinetic profile of FF-10501-01 and its metabolite.
- (and 4 more...)
|
68 |
All |
18 Years and older (Adult, Senior) |
NCT02193958 |
BS FF1050101US01 |
|
July 2014 |
June 2018 |
December 2018 |
July 18, 2014 |
February 6, 2018 |
|
- Cleveland Clinic at Taussig Cancer Center
Cleveland, Ohio, United States - M D Anderson Cancer Center
Houston, Texas, United States
|
37 |
NCT02530034 |
Not yet recruiting |
Phase I Study of Hu8F4 in Patients With Advanced Hematologic Malignancies |
|
|
Interventional |
Phase 1 |
- M.D. Anderson Cancer Center
- The Leukemia and Lymphoma Society
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of Hu8F4 During Dose Escalation
- Maximum Tolerated Dose (MTD) of Hu8F4 During Dose Expansion Determined by Dose Limiting Toxicity
- Overall Survival Estimated Using the Kaplan-Meier Methods
- (and 3 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02530034 |
2014-0057 P-TRP-2447-14 NCI-2015-02131 |
|
June 2018 |
June 2021 |
June 2022 |
August 20, 2015 |
April 12, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
38 |
NCT01339988 |
Not yet recruiting |
Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT) |
- Acute Leukemias
- Chronic Leukemias
- Myelodysplastic Syndrome
- Juvenile Myelomonocytic Leukemia
|
- Drug: Busulfan/Cyclophosphamide
|
Interventional |
Phase 4 |
- Tel-Aviv Sourasky Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Disease free survival
|
10 |
Male |
up to 21 Years (Child, Adult) |
NCT01339988 |
TASMC-11-MB-442-CTIL |
|
June 2011 |
June 2014 |
June 2019 |
April 21, 2011 |
April 21, 2011 |
|
|
39 |
NCT03314974 |
Not yet recruiting |
Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders |
- Acute Leukemia
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- (and 25 more...)
|
- Biological: HSCT with TBI Regimen
- Biological: HSCT with Non-TBI Regimen
|
Interventional |
Phase 2 |
- Masonic Cancer Center, University of Minnesota
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Chronic GVHD - 1 year
- Grade II-IV acute GVHD
- Chronic GVHD - 2 years
- (and 6 more...)
|
40 |
All |
Child, Adult, Senior |
NCT03314974 |
2015LS034 MT2015-29 |
|
December 10, 2018 |
November 10, 2022 |
November 10, 2023 |
October 19, 2017 |
December 19, 2017 |
|
|
40 |
NCT02338479 |
Recruiting |
Natural History and Biology of Long-Term Late Effects Following Hematopoietic Cell Transplant for Childhood Hematologic Malignancies |
- Acute Lymphoblastic Leukemia/Lymphoma
- Myelodysplasia
- Acute Myelogenous Leukemia
- (and 2 more...)
|
|
Observational |
|
- Center for International Blood and Marrow Transplant Research
- Pediatric Blood and Marrow Transplant Consortium
- National Marrow Donor Program
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To report the incidence of chronic kidney disease (CKD), metabolic syndrome, and osteopenia
- To identify prognostic risk factors for the development and progression of post-HCT CKD, metabolic syndrome, and osteopenia
- To investigate potential associations of systemic hypertension as measured with intermittent blood pressure assessment with proteinuria, acute kidney injury, and CKD
- (and 7 more...)
|
340 |
All |
up to 22 Years (Child, Adult) |
NCT02338479 |
13-TLEC |
|
March 2015 |
February 2020 |
February 2020 |
January 14, 2015 |
February 6, 2018 |
|
- Mayo Clinic
Scottsdale, Arizona, United States - University of Arizona Medical Center
Tucson, Arizona, United States - Children's Hospital of Los Angeles
Los Angeles, California, United States - (and 29 more...)
|
41 |
NCT03263637 |
Recruiting |
Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies |
- Relapsed or Refractory Haematological Malignancies Including
- Acute Myeloid Leukemia
- Acute Lymphocytic Leukemia
- (and 8 more...)
|
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events
- Dose limiting toxicities
- maximum tolerated dose
- (and 10 more...)
|
42 |
All |
18 Years to 130 Years (Adult, Senior) |
NCT03263637 |
D8230C00001 |
|
October 24, 2017 |
October 31, 2019 |
October 31, 2019 |
August 28, 2017 |
March 29, 2018 |
|
- Research Site
Aachen, Germany - Research Site
Bonn, Germany - Research Site
Heidelberg, Germany - (and 9 more...)
|
42 |
NCT02790515 |
Recruiting |
Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation |
- Acute Lymphoblastic Leukemia (ALL)
- Acute Myeloid Leukemia (AML)
- Myeloid Sarcoma
- (and 4 more...)
|
- Drug: Anti-thymocyte globulin (rabbit)
- Drug: Blinatumomab
- Drug: Cyclophosphamide
- (and 10 more...)
|
Interventional |
Phase 2 |
- St. Jude Children's Research Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The number of patients engrafted by day +30 post-transplant
- The number of patients experiencing Blinatumomab permanent discontinuation due to toxicity
- The estimate of cumulative incidence of relapse
- (and 2 more...)
|
18 |
All |
up to 21 Years (Child, Adult) |
NCT02790515 |
REF2HCT NCI-2016-00812 |
|
June 14, 2016 |
June 2019 |
June 2020 |
June 6, 2016 |
January 5, 2018 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
43 |
NCT02268253 |
Recruiting |
SL-401 in Advanced, High Risk Myeloproliferative Neoplasms (Systemic Mastocytosis, Advanced Symptomatic Hypereosinoophic Disorder, Myelofibrosis, Chronic Myelomonocytic Leukemia) |
- Myelofibrosis
- Chronic Myelomonocytic Leukemia
|
|
Interventional |
Phase 1 Phase 2 |
- Stemline Therapeutics, Inc.
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02268253 |
STML-401-0314 |
|
December 2014 |
December 2018 |
June 2019 |
October 20, 2014 |
January 29, 2018 |
|
- City of Hope
Duarte, California, United States - University of California, Los Angeles
Los Angeles, California, United States - University of Kansas Cancer Center
Westwood, Kansas, United States - (and 8 more...)
|
44 |
NCT03190915 |
Recruiting |
Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia |
- Activating RAS Mutation
- Juvenile Myelomonocytic Leukemia
- Monosomy 7
- (and 4 more...)
|
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Drug: Trametinib
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective response
- Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- Pharmacokinetic parameters of trametinib
|
24 |
All |
2 Years to 21 Years (Child, Adult) |
NCT03190915 |
NCI-2017-00921 ADVL1521 U10CA180886 |
|
October 6, 2017 |
December 30, 2020 |
December 30, 2020 |
June 19, 2017 |
April 23, 2018 |
|
- Phoenix Childrens Hospital
Phoenix, Arizona, United States - Arkansas Children's Hospital
Little Rock, Arkansas, United States - Southern California Permanente Medical Group
Downey, California, United States - (and 27 more...)
|
45 |
NCT00309842 |
Recruiting |
Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases |
- Acute Myeloid Leukemia
- Acute Lymphocytic Leukemia
- Chronic Myelogenous Leukemia
- (and 10 more...)
|
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: cyclosporine
- (and 4 more...)
|
Interventional |
Phase 2 |
- Masonic Cancer Center, University of Minnesota
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Patients Who Died Due to Transplant
- Chimerism
- (and 4 more...)
|
150 |
All |
up to 55 Years (Child, Adult) |
NCT00309842 |
2005LS043 UMN-MT2005-10 UMN-0507M71475 |
|
July 2005 |
October 2018 |
October 2018 |
April 3, 2006 |
December 2, 2017 |
|
- Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States - Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
|
46 |
NCT03306264 |
Recruiting |
Study of ASTX727 vs IV Decitabine in MDS and CMML |
- Myelodysplastic Syndromes
- Chronic Myelomonocytic Leukemia
|
- Drug: ASTX727
- Drug: Dacogen
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Total 5-day Area Under the Curve (AUC) exposures of decitabine
- Numbers of subjects with adverse events (AEs); the severity (intensity) of AEs will be graded according to CTCAE v4.03.
- Long Interspersed Nucleotide Elements (LINE)-1 demethylation
- (and 11 more...)
|
132 |
All |
18 Years and older (Adult, Senior) |
NCT03306264 |
ASTX727-02 |
|
February 15, 2018 |
December 31, 2018 |
June 30, 2019 |
October 11, 2017 |
April 17, 2018 |
|
- Regional Cancer Care Associates
Bethesda, Maryland, United States - Hackensack
Hackensack, New Jersey, United States - Roswell Park
Buffalo, New York, United States - (and 4 more...)
|
47 |
NCT03333486 |
Recruiting |
Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer |
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Leukemia in Remission
- Acute Lymphoblastic Leukemia
- (and 34 more...)
|
- Drug: Cyclophosphamide
- Drug: Fludarabine Phosphate
- Other: Laboratory Biomarker Analysis
- (and 2 more...)
|
Interventional |
Phase 2 |
- Roswell Park Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Relapse rate
- Engraftment rate
- Incidence of acute graft versus host disease (GVHD)
- (and 4 more...)
|
58 |
All |
1 Year to 75 Years (Child, Adult, Senior) |
NCT03333486 |
I 40916 NCI-2017-01949 P30CA016056 |
|
December 7, 2017 |
September 6, 2021 |
September 6, 2022 |
November 7, 2017 |
December 11, 2017 |
|
- Roswell Park Cancer Institute
Buffalo, New York, United States
|
48 |
NCT01384513 |
Recruiting |
A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies |
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- (and 44 more...)
|
- Drug: Fludarabine
- Drug: Busulfan
- Radiation: Total Body Irradiation (TBI)
- (and 6 more...)
|
Interventional |
Phase 2 |
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Thomas Jefferson University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival (OS) in patients with haploidentical family donors with hematological malignancies in morphological or radiographic remission or with chemosensitive, indolent diseases
- Treatment Related Mortality (TRM)
- Incidence and severity of GVHD, graded according to standard criteria
- (and 5 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT01384513 |
11D.247 2011-31 |
|
August 4, 2011 |
December 1, 2019 |
July 2020 |
June 29, 2011 |
December 6, 2017 |
|
- Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
49 |
NCT01760655 |
Recruiting |
Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies |
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- (and 65 more...)
|
- Drug: Fludarabine phosphate
- Drug: Thiotepa
- Radiation: Total body irradiation
- (and 6 more...)
|
Interventional |
Phase 2 |
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Thomas Jefferson University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease-free survival (DFS)
- Overall survival
- Incidence of Regimen Related Toxicity
- (and 3 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT01760655 |
12D.501 2012-67 |
|
December 24, 2012 |
December 2019 |
January 2020 |
January 4, 2013 |
March 6, 2018 |
|
- Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
50 |
NCT00619879 |
Recruiting |
Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies |
- Leukemia, Myelogenous, Chronic
- Leukemia, Lymphoblastic, Acute
- Leukemia, Myelogenous, Acute
- (and 2 more...)
|
- Drug: Myeloablative Chemotherapy Regimen for Lymphoid Malignancies or Cord Blood Unit Recipients
- Drug: Myeloablative Chemotherapy Regimen for Non-Cord Blood Unit Recipients with Myeloid Malignancies
- Other: Hematopoietic Progenitor Cell Transplantation (HPCT)
- Radiation: CNS radiation treatment for ALL with prior CNS disease patients
|
Interventional |
Phase 3 |
- Ann & Robert H Lurie Children's Hospital of Chicago
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluate the morbidity and mortality of hematopoietic progenitor cell transplantation (HPCT) at Children's Memorial Hospital.
- Evaluate the effectiveness of graft versus host disease prevention with a combination of anti-thymocyte globulin, continuous infusion cyclosporine, and short course methotrexate for transplants.
- Determine the toxicity of a single conditioning regimen consisting of total body irradiation, etoposide, and Cyclophosphamide for patients with transplant eligible lymphoid malignant conditions or myeloid malignant conditions receiving cord blood units.
- Determine the toxicity of a single conditioning regimen consisting of Busulfan and Cyclophosphamide for patients with transplant eligible myeloid malignant conditions who are not receiving cord blood units.
|
200 |
All |
up to 21 Years (Child, Adult) |
NCT00619879 |
SCT 0307 |
|
March 2007 |
January 2020 |
January 2020 |
February 21, 2008 |
March 30, 2011 |
|
- Children's Memorial Hospital
Chicago, Illinois, United States
|