1 |
NCT02578511 |
Withdrawn |
Standard Maintenance POMP/D Plus Ixazomib Maintenance Therapy in Adult Patients With Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma or Mixed Phenotype Acute Leukemia in Complete Remission (CR) |
- Acute Lymphoblastic Leukemia in Complete Remission
- Lymphoblastic Lymphoma in Complete Remission
- Mixed Phenotype Acute Leukemia in Complete Remission
|
|
Interventional |
Phase 1 |
- Ehab L Atallah
- Medical College of Wisconsin
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of ixazomib with POMP/D maintenance
- Progression-free survival of patients treated with oral Ixazomib and standard maintenance regimen.
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT02578511 |
PRO25835 |
|
June 29, 2017 |
February 13, 2018 |
February 13, 2018 |
October 19, 2015 |
February 15, 2018 |
|
- Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
|
2 |
NCT01887587 |
Terminated |
Phase I Study Of Vincristine, Doxorubicin, And Dexamethasone (VXD) Plus Ixazomib In Adults With Relapsed Or Refractory Acute Lymphoblastic Leukemia/Lymphoma, Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia |
- Relapsed or Refractory Acute Lymphoblastic Leukemia
- Relapsed or Refractory Lymphoblastic Lymphoma
- Mixed Phenotype Acute Leukemia
|
- Drug: MLN9708
- Drug: Vincristine
- Drug: Doxorubicin
- Drug: Dexamethasone
|
Interventional |
Phase 1 |
- Ehab L Atallah
- Medical College of Wisconsin
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the number of patients with adverse events.
- To determine the optimal dose of MLN9708
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT01887587 |
PRO00020384 |
|
October 2013 |
December 2017 |
August 2018 |
June 27, 2013 |
February 12, 2016 |
|
- Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
|
3 |
NCT02135874 |
Recruiting |
A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids - Mixed Phenotype Acute Leukemia (MPAL) |
|
- Drug: Clofarabine
- Drug: Idarubicin
- Drug: Cytarabine
- (and 3 more...)
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response Rate of Newly Diagnosed Mixed Phenotype Acute Leukemia
- Response Rate of Relapsed Mixed Phenotype Acute Leukemia
|
60 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02135874 |
2013-0073 NCI-2014-02322 |
|
October 2014 |
October 2019 |
October 2020 |
May 12, 2014 |
February 12, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
4 |
NCT01701323 |
Active, not recruiting |
Laboratory-Treated Donor Cord Blood Cell Infusion Following Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia |
- Acute Leukemia of Ambiguous Lineage
- Adult Acute Myeloid Leukemia in Remission
- Childhood Acute Myeloid Leukemia in Remission
- (and 3 more...)
|
- Drug: Cytarabine
- Procedure: Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion
- Biological: Filgrastim
- Drug: Fludarabine Phosphate
|
Interventional |
Not Applicable |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
- Seattle Children's Research Institute Center for Clinical and Translational Research
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Delayed marrow recovery
- Incidence of platelet refractoriness in the presence of alloimmunization as a direct result of ex vivo expanded cord blood product infusion
- Occurrence of grade > 3 infusional toxicity with administration of ex vivo expanded cord blood therapy
- (and 12 more...)
|
15 |
All |
6 Months to 30 Years (Child, Adult) |
NCT01701323 |
2584.00 NCI-2012-01724 2584 2378 P30CA015704 |
|
December 10, 2012 |
August 5, 2018 |
August 5, 2018 |
October 5, 2012 |
July 2, 2017 |
|
- Emory University/Winship Cancer Institute
Atlanta, Georgia, United States - Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
5 |
NCT02799147 |
Recruiting |
GVHD Prophylaxis With Post-transplantation Bendamustine in Refractory Leukemia |
- Leukemia, Acute Lymphoblastic
- Acute Myeloid Leukemia
- Mixed-Lineage Acute Leukemias
|
- Procedure: Allogeneic stem cell transplantation
- Drug: Fludarabine monophosphate
- Drug: Busulfan
- Drug: Bendamustine
|
Interventional |
Phase 1 Phase 2 |
- St. Petersburg State Pavlov Medical University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Engraftment rate
- Relapse rate analysis
- Non-relapse mortality analysis
- (and 6 more...)
|
30 |
All |
18 Years to 60 Years (Adult) |
NCT02799147 |
05/16-n |
|
June 2016 |
June 2018 |
June 2019 |
June 14, 2016 |
August 24, 2017 |
|
- First Pavlov State Medical University of St. Petersburg
Saint-Petersburg, Russian Federation
|
6 |
NCT02419755 |
Terminated Has Results |
Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies |
- Mixed Lineage Acute Leukemia
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
|
- Drug: Bortezomib
- Drug: Vorinostat
- Drug: Mitoxantrone
- (and 8 more...)
|
Interventional |
Phase 2 |
- St. Jude Children's Research Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate in All Participants
- Number of Participants With 3 Year Event Free Survival (EFS)
- Number of Participants With 5- Year Event Free Survival
- (and 5 more...)
|
12 |
All |
up to 21 Years (Child, Adult) |
NCT02419755 |
RELMLL NCI-2015-00602 |
|
April 14, 2015 |
December 31, 2016 |
December 31, 2016 |
April 17, 2015 |
March 7, 2018 |
February 1, 2018 |
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
7 |
NCT03012672 |
Recruiting |
Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm |
- Acute Leukemia of Ambiguous Lineage
- Acute Myeloid Leukemia
- Myeloid Neoplasm
|
- Drug: Cladribine
- Drug: Cytarabine
- Biological: Granulocyte Colony-Stimulating Factor
- (and 3 more...)
|
Interventional |
Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Feasibility defined as proportion of patients willing to be randomized to either intensive or non-intensive induction and post remission chemotherapy
- Attitude of patients toward randomization as determined by a patient preference survey
- Care costs
- (and 9 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03012672 |
9759 NCI-2016-02051 P30CA015704 |
|
December 30, 2016 |
July 15, 2020 |
July 15, 2020 |
January 6, 2017 |
June 21, 2017 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
8 |
NCT01804101 |
Active, not recruiting |
Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia |
- Acute Biphenotypic Leukemia
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Untreated Adult Acute Myeloid Leukemia
|
- Other: Laboratory Biomarker Analysis
- Drug: Liposomal Cytarabine-Daunorubicin CPX-351
|
Interventional |
Not Applicable |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response (CR or CRp) rate categorized according to criteria recommended by International Working Groups
- TRM rate
|
90 |
All |
18 Years and older (Adult, Senior) |
NCT01804101 |
2642.00 NCI-2013-00481 2642 P30CA015704 |
|
May 7, 2013 |
January 10, 2017 |
|
March 5, 2013 |
June 19, 2017 |
|
- Stanford Cancer Institute
Palo Alto, California, United States - Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
9 |
NCT02828358 |
Recruiting |
Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement |
- Acute Leukemia of Ambiguous Lineage
- Childhood B Acute Lymphoblastic Leukemia
- KMT2A Gene Rearrangement
- Mixed Phenotype Acute Leukemia
|
- Drug: Azacitidine
- Drug: Cyclophosphamide
- Drug: Cytarabine
- (and 12 more...)
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events of azacitidine and combination chemotherapy, graded according to Common Terminology Criteria for Adverse Events 4.0 (version 5.0 beginning April 1, 2018)
- Biologic activity, defined as global deoxyribonucleic acid (DNA) methylation change in peripheral blood mononuclear cells (PBMC)s
|
116 |
All |
up to 364 Days (Child) |
NCT02828358 |
NCI-2016-00973 s17-00488 AALL15P1 U10CA180886 |
|
March 27, 2017 |
September 30, 2019 |
September 30, 2019 |
July 11, 2016 |
April 24, 2018 |
|
- Children's Hospital of Alabama
Birmingham, Alabama, United States - University of South Alabama
Mobile, Alabama, United States - Providence Alaska Medical Center
Anchorage, Alaska, United States - (and 159 more...)
|
10 |
NCT03194932 |
Recruiting |
Study of Venetoclax in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage |
|
- Drug: Venetoclax
- Drug: Cytarabine
- Drug: Idarubicin
- Drug: Intrathecal Triple Therapy
|
Interventional |
Phase 1 |
- St. Jude Children's Research Hospital
- Gateway for Cancer Research
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated combination (MTC)
|
54 |
All |
2 Years to 20 Years (Child, Adult) |
NCT03194932 |
VENAML NCI-2017-01129 |
|
July 11, 2017 |
August 2020 |
August 2020 |
June 21, 2017 |
March 29, 2018 |
|
- UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States - St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
11 |
NCT03267186 |
Recruiting |
Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant |
- Acute Biphenotypic Leukemia
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- (and 2 more...)
|
- Drug: Ibrutinib
- Other: Laboratory Biomarker Analysis
|
Interventional |
Phase 2 |
- Andrew Rezvani
- National Cancer Institute (NCI)
- Stanford University
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Incidence of relapsed leukemia defined as > 5% leukemic blasts detected in bone marrow or peripheral blood
- Incidence of acute GVHD grades II-IV and III-IV evaluated according standard criteria
- Incidence of chronic GVHD evaluated according to 2014 National Institutes of Health consensus criteria
- Incidence of detectable minimal residual disease assessed using high-throughput sequencing (ClonoSEQ) and high-sensitivity flow cytometry
|
50 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03267186 |
BMT302 NCI-2017-00125 IRB-38934 |
|
September 12, 2017 |
September 2019 |
March 2020 |
August 30, 2017 |
October 12, 2017 |
|
- Stanford University, School of Medicine
Palo Alto, California, United States
|
12 |
NCT01132573 |
Completed |
Entinostat and Clofarabine in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Poor-Risk Acute Lymphoblastic Leukemia or Bilineage/Biphenotypic Leukemia |
- Acute Leukemias of Ambiguous Lineage
- Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Untreated Adult Acute Lymphoblastic Leukemia
|
- Drug: entinostat
- Drug: clofarabine
- Other: pharmacological study
- Other: laboratory biomarker analysis
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Frequency of the observed toxicities based on the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- MTD of entinostat followed by clofarabine, defined as the dose at which less than 2 of 3 patients experience dose limiting toxicity graded according to NCI CTCAE version 4.0
- Percentage change in phosphorylated H2A histone family, member X (H2AX), an indication of DNA damage
- (and 2 more...)
|
27 |
All |
21 Years and older (Adult, Senior) |
NCT01132573 |
NCI-2011-01436 CDR0000671796 JHOC-MD017 J09112 8298 U01CA070095 P30CA006973 |
|
April 2010 |
June 2014 |
|
May 28, 2010 |
July 17, 2014 |
|
- University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States - University of Colorado
Denver, Colorado, United States - University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States - Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
|
13 |
NCT02728050 |
Recruiting |
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib Tosylate in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome |
- Acute Biphenotypic Leukemia
- Acute Myeloid Leukemia
- de Novo Myelodysplastic Syndrome
- (and 2 more...)
|
- Drug: Cladribine
- Drug: Cytarabine
- Biological: Filgrastim
- (and 4 more...)
|
Interventional |
Phase 1 Phase 2 |
- University of Washington
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD), defined as the highest dose studied in which the incidence of dose-limiting toxicity is < 33% assuming at least 6 patients have been treated at this dose (Phase I)
- Minimal residual disease negative (MRDneg) complete response (CR) rate (Phase II)
- Complete response (CR)
- (and 16 more...)
|
71 |
All |
18 Years to 60 Years (Adult) |
NCT02728050 |
9510 NCI-2016-00286 P30CA015704 |
|
December 1, 2016 |
December 1, 2018 |
|
April 5, 2016 |
April 5, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
14 |
NCT02879695 |
Recruiting |
Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia |
- B Acute Lymphoblastic Leukemia
- B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- CD19-Positive Neoplastic Cells Present
- (and 2 more...)
|
- Biological: Blinatumomab
- Biological: Ipilimumab
- Other: Laboratory Biomarker Analysis
- Biological: Nivolumab
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- Maximum tolerated dose defined as the maximum dose level in the absence of dose limiting toxicity in each patient assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- Minimal residual disease assessed by flow cytometry
- (and 6 more...)
|
30 |
All |
16 Years and older (Child, Adult, Senior) |
NCT02879695 |
NCI-2016-01300 10030 UM1CA186691 |
|
May 5, 2017 |
November 5, 2021 |
November 5, 2021 |
August 26, 2016 |
March 5, 2018 |
|
- Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States - University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
|
15 |
NCT02212561 |
Completed |
Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome |
- Acute Myeloid Leukemia (AML)
- Acute Lymphoblastic Leukemia (ALL)
- Myelodysplastic Syndrome (MDS)
- Mixed Phenotype Acute Leukemia (MPAL)
|
- Drug: Selinexor
- Drug: Fludarabine
- Drug: Cytarabine
- Drug: methotrexate/hydrocortisone/cytarabine
|
Interventional |
Phase 1 |
- St. Jude Children's Research Hospital
- Karyopharm Therapeutics Inc
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD) of combination selinexor, fludarabine and cytarabine
- Dose limiting toxicity of combination selinexor, fludarabine and cytarabine
- Maximum plasma concentration (Cmax) of selinexor
- (and 3 more...)
|
19 |
All |
up to 24 Years (Child, Adult) |
NCT02212561 |
SELHEM NCI-2014-01704 |
|
August 2014 |
December 2015 |
December 2015 |
August 8, 2014 |
March 3, 2017 |
|
- Phoenix Children's Hospital
Phoenix, Arizona, United States - Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States - University of Chicago
Chicago, Illinois, United States - (and 3 more...)
|
16 |
NCT02220985 |
Recruiting |
Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD |
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Biphenotypic Leukemia
- Acute Leukemia of Ambiguous Lineage
- (and 18 more...)
|
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Cyclophosphamide
- Drug: Fludarabine Phosphate
- (and 7 more...)
|
Interventional |
Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Graft failure
- Occurrence of chronic graft-versus-host disease (GHVD), defined operationally as the occurrence of compatible symptoms meeting National Institutes of Health criteria and requiring systemic pharmacological immunosuppression
- Presence of acute graft-versus-host disease (GVHD) grades II-IV
- (and 12 more...)
|
80 |
All |
up to 60 Years (Child, Adult) |
NCT02220985 |
2684.00 NCI-2014-01301 K23CA154532 P30CA015704 R01HL121568 |
|
February 3, 2015 |
February 3, 2019 |
|
August 20, 2014 |
October 27, 2017 |
|
- University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States - Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
17 |
NCT01690520 |
Recruiting |
Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes |
- Acute Biphenotypic Leukemia
- Acute Erythroid Leukemia
- Acute Lymphoblastic Leukemia in Remission
- (and 12 more...)
|
- Drug: Cyclophosphamide
- Drug: Cyclosporine
- Procedure: Double-Unit Umbilical Cord Blood Transplantation
- (and 7 more...)
|
Interventional |
Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to engraftment defined as the first 2 consecutive days in which absolute neutrophil count >= 500 in both arms (standard myeloablative cord blood transplantation with and without off-the-shelf expanded cord blood progenitors)
- Platelet engraftment (20k)
- Incidence of infectious complications
- (and 3 more...)
|
160 |
All |
6 Months to 65 Years (Child, Adult) |
NCT01690520 |
2603.00 NCI-2012-01572 2603 P30CA015704 P50HL110787 |
|
December 11, 2012 |
October 31, 2018 |
|
September 21, 2012 |
March 7, 2018 |
|
- City of Hope Comprehensive Cancer Center
Duarte, California, United States - Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States - Stanford Cancer Institute Palo Alto
Palo Alto, California, United States - (and 7 more...)
|
18 |
NCT01858740 |
Active, not recruiting |
Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children |
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Biphenotypic Leukemia
- Acute Leukemia of Ambiguous Lineage
- (and 15 more...)
|
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Fludarabine Phosphate
- Other: Laboratory Biomarker Analysis
- (and 6 more...)
|
Interventional |
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
|
- Graft failure defined as failure to reach an absolute neutrophil count (ANC) of > 500/ul for 3 consecutive days or irreversible decrease in ANC to < 100 after an established donor graft
- Time to ANC of > 1,000/uL
- Time to ANC of > 500/uL
- (and 10 more...)
|
20 |
All |
up to 21 Years (Child, Adult) |
NCT01858740 |
2660.00 NCI-2013-00958 2660 K23CA154532 P30CA015704 |
|
December 17, 2013 |
January 30, 2022 |
January 30, 2022 |
May 21, 2013 |
April 24, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
19 |
NCT02044796 |
Active, not recruiting |
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes |
- Acute Biphenotypic Leukemia
- de Novo Myelodysplastic Syndrome
- Previously Treated Myelodysplastic Syndrome
- (and 3 more...)
|
- Drug: Cladribine
- Drug: Cytarabine
- Biological: Filgrastim
- (and 2 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
|
- Maximum tolerated dose of mitoxantrone, defined as the highest dose studied in which the incidence of dose-limiting toxicity is < 33%, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
- Minimal residual disease negative complete remission rate in patients with newly diagnosed disease (Phase II)
- Overall survival rate (Phase II expansion cohort)
- Remission rate (complete remission and complete remission with incomplete platelet count recovery) of this regimen in patients with relapsed/refractory disease (Phase II)
|
199 |
All |
18 Years and older (Adult, Senior) |
NCT02044796 |
2734.00 NCI-2013-02465 P30CA015704 |
|
January 23, 2014 |
August 1, 2018 |
August 1, 2022 |
January 24, 2014 |
January 9, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
20 |
NCT01925131 |
Recruiting |
S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia |
- Acute Leukemias of Ambiguous Lineage
- B-cell Adult Acute Lymphoblastic Leukemia
- Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
- (and 2 more...)
|
- Drug: cyclophosphamide
- Drug: vincristine sulfate
- Drug: prednisone
- (and 2 more...)
|
Interventional |
Phase 1 |
- Southwest Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MTD of inotuzumab ozogamicin with CVP defined as the highest dose studied in which the incidence of dose-limiting toxicities is < 33% using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
- Response rate (CR+CRi)
- Frequency of toxicities graded according to NCI CTCAE version 4.0
- Severity of toxicities graded according to NCI CTCAE version 4.0
|
38 |
All |
18 Years and older (Adult, Senior) |
NCT01925131 |
S1312 NCI-2013-01368 U10CA180888 U10CA032102 |
|
April 2014 |
January 2022 |
January 2023 |
August 19, 2013 |
April 10, 2018 |
|
- City of Hope Comprehensive Cancer Center
Duarte, California, United States - Stanford Cancer Institute Palo Alto
Palo Alto, California, United States - University of Rochester
Rochester, New York, United States - (and 2 more...)
|
21 |
NCT03399773 |
Not yet recruiting |
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes |
- Acute Biphenotypic Leukemia
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukemia in Remission
- (and 8 more...)
|
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Other: Laboratory Biomarker Analysis
- (and 4 more...)
|
Interventional |
Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Graft failure
- Incidence and severity of acute graft versus host disease (GVHD)
- Incidence and severity of chronic graft versus host disease (GVHD)
- (and 4 more...)
|
15 |
All |
18 Years to 65 Years (Adult) |
NCT03399773 |
9910 NCI-2017-02205 P30CA015704 P50HL110787 |
|
May 15, 2018 |
March 15, 2022 |
March 15, 2022 |
January 16, 2018 |
March 29, 2018 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States - Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
22 |
NCT03195010 |
Enrolling by invitation |
Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia |
- Acute Biphenotypic Leukemia
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- (and 11 more...)
|
- Biological: Platelet Transfusion
|
Interventional |
Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Number of eligible patients approached for the study
- Number of patients approached for but refusing consent
- Number of patients consenting to enrollment
- (and 10 more...)
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT03195010 |
9799 NCI-2017-00864 P30CA015704 |
|
June 9, 2017 |
October 5, 2018 |
October 5, 2018 |
June 22, 2017 |
February 16, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
23 |
NCT02159495 |
Recruiting |
Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm |
- Adult Acute Myeloid Leukemia in Remission
- Acute Biphenotypic Leukemia
- Early Relapse of Acute Myeloid Leukemia
- (and 10 more...)
|
- Drug: cyclophosphamide
- Biological: Autologous CD123CAR-CD28-CD3zeta-EGFRt-expressing T Lymphocytes
- Other: laboratory biomarker analysis
- (and 2 more...)
|
Interventional |
Phase 1 |
- City of Hope Medical Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose-limiting toxicity (DLT) defined as any grade 3 or higher toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Incidence of adverse events as assessed by NCI CTCAE version 4.0
- Disease response (CR or CRi)
- (and 5 more...)
|
60 |
All |
12 Years and older (Child, Adult, Senior) |
NCT02159495 |
13272 NCI-2014-01147 |
|
December 1, 2015 |
December 2018 |
December 2018 |
June 10, 2014 |
March 6, 2018 |
|
- City of Hope Medical Center
Duarte, California, United States
|
24 |
NCT01028716 |
Recruiting |
Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies |
- Acute Biphenotypic Leukemia
- Acute Erythroid Leukemia in Remission
- Acute Leukemia in Remission
- (and 27 more...)
|
- Drug: Cyclophosphamide
- Biological: Filgrastim
- Drug: Fludarabine Phosphate
- (and 6 more...)
|
Interventional |
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
|
- Cumulative incidence of non-relapse mortality, defined as death without evidence of disease progression
- Incidence of chronic graft versus host disease
- Incidence of grades III/IV acute graft versus host disease
- (and 9 more...)
|
50 |
All |
Child, Adult, Senior |
NCT01028716 |
2372.00 NCI-2009-01433 2372 P30CA015704 |
|
February 8, 2010 |
August 1, 2018 |
|
December 9, 2009 |
December 13, 2017 |
|
- VA Puget Sound Health Care System
Seattle, Washington, United States - Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
25 |
NCT00796068 |
Recruiting |
Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant |
- Acute Biphenotypic Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Myeloid Leukemia in Remission
- (and 8 more...)
|
- Drug: Cyclosporine
- Drug: Fludarabine Phosphate
- Other: Laboratory Biomarker Analysis
- (and 4 more...)
|
Interventional |
Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of graft failure/rejection
- Incidence of secondary graft failure
- Incidence of non-relapse mortality
- (and 9 more...)
|
130 |
All |
up to 65 Years (Child, Adult) |
NCT00796068 |
2275.00 NCI-2010-00299 2275 P30CA015704 |
|
October 29, 2008 |
December 31, 2018 |
|
November 24, 2008 |
April 13, 2018 |
|
- University of Colorado Hospital
Aurora, Colorado, United States - Oregon Health and Science University
Portland, Oregon, United States - Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
26 |
NCT00719888 |
Recruiting |
Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematologic Disease |
- Acute Biphenotypic Leukemia
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Acute Myeloid Leukemia in Remission
- (and 22 more...)
|
- Drug: Cyclophosphamide
- Drug: Cyclosporine
- Procedure: Double-Unit Umbilical Cord Blood Transplantation
- (and 5 more...)
|
Interventional |
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
|
- Overall survival
- Incidence of transplant-related mortality
- Chimerism analysis
- (and 7 more...)
|
75 |
All |
6 Months to 45 Years (Child, Adult) |
NCT00719888 |
2010.00 NCI-2010-00190 FHCRC 2010.00 Protocol 2010 2010 P30CA015704 |
|
November 18, 2005 |
December 31, 2018 |
|
July 22, 2008 |
March 27, 2018 |
|
- University of Colorado Hospital
Aurora, Colorado, United States - VA Puget Sound Health Care System
Seattle, Washington, United States - Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
27 |
NCT01951885 |
Recruiting |
Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention |
- Chronic Myelogenous Leukemia
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- (and 7 more...)
|
- Drug: tacrolimus
- Drug: methotrexate
- Drug: Mycophenolate mofetil
- Drug: Methotrexate (low dose)
|
Interventional |
Phase 3 |
- Case Comprehensive Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Incidence of severe (grade 3-4) mucositis graded according to the World Health Organization (WHO) grading scale
- Time to neutrophil engraftment
- Time to platelet engraftment
- (and 11 more...)
|
100 |
All |
up to 70 Years (Child, Adult, Senior) |
NCT01951885 |
CASE6Z13 NCI-2013-01800 CASE 6Z13 P30CA043703 |
|
May 21, 2014 |
July 2018 |
July 2019 |
September 27, 2013 |
March 13, 2018 |
|
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States - Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
|
28 |
NCT03326921 |
Recruiting |
HA-1 T TCR T Cell Immunotherapy for the Treating of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant |
- HLA-A*0201 HA-1 Positive Cells Present
- Minimal Residual Disease
- Recurrent Acute Biphenotypic Leukemia
- (and 8 more...)
|
- Biological: CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR
- Drug: Fludarabine Phosphate
- Other: Laboratory Biomarker Analysis
|
Interventional |
Phase 1 |
- Fred Hutchinson Cancer Research Center
- Alex Lemonade Stand Foundation
- National Cancer Institute (NCI)
- The Leukemia and Lymphoma Society
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Feasibility of manufacturing minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells
- Feasibility of administering minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells
- Incidence of dose-limiting toxicities of HA-1 T cell receptor (TCR) T cells
- (and 9 more...)
|
24 |
All |
up to 70 Years (Child, Adult, Senior) |
NCT03326921 |
9716 NCI-2017-01054 P30CA015704 |
|
April 23, 2018 |
December 16, 2019 |
October 16, 2020 |
October 31, 2017 |
March 29, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
29 |
NCT02793544 |
Recruiting |
HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide |
- Myelodysplastic Syndrome (MDS)
- Chronic Lymphocytic Leukemia (CLL)
- Chemotherapy-sensitive Lymphoma
- (and 4 more...)
|
- Drug: Fludarabine
- Drug: Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Radiation: Total Body Irradiation (TBI) 200cGy on Day -1
- (and 13 more...)
|
Interventional |
Phase 2 |
- Center for International Blood and Marrow Transplant Research
- National Marrow Donor Program
- Resource for Clinical Investigation in Blood and Marrow Transplantation
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival
- Progression-free survival
- Transplant-related mortality
- (and 15 more...)
|
80 |
All |
15 Years to 70 Years (Child, Adult, Senior) |
NCT02793544 |
15-MMUD |
|
December 2016 |
December 2019 |
December 2019 |
June 8, 2016 |
April 19, 2018 |
|
- Shands HealthCare & University of Florida
Gainesville, Florida, United States - University of Miami
Miami, Florida, United States - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States - (and 7 more...)
|
30 |
NCT03198234 |
Recruiting |
Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders |
- AML - Acute Myeloid Leukemia
- MDS (Myelodysplastic Syndrome)
- Mixed Phenotype Acute Leukemia
- (and 3 more...)
|
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of treatment emergent adverse events (TEAE)
- Severity of treatment emergent adverse events (TEAE)
- Safety of T-allo10 will be measured by the time to stem cell engraftment after Hematopoietic Stem Cell Transplant.
- (and 2 more...)
|
30 |
All |
3 Years to 30 Years (Child, Adult) |
NCT03198234 |
SU-IRB-38734 |
T-allo10 |
August 30, 2017 |
July 2019 |
July 2020 |
June 26, 2017 |
September 21, 2017 |
|
- Lucile Packard Children's Hospital
Palo Alto, California, United States
|
31 |
NCT01319864 |
Active, not recruiting |
POETIC Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients |
- Relapsed/Refractory AML
- Relapsed/Refractory ALL
- Secondary AML/MDS
- (and 3 more...)
|
- Drug: Plerixafor Dose Escalation
|
Interventional |
Phase 1 |
- Seattle Children's Hospital
- Children's Healthcare of Atlanta
- Pediatric Oncology Experimental Therapeutics Investigation Consortium
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of Plerixafor given in combination with chemotherapy
- Response Rate
- Pharmacokinetics
- (and 2 more...)
|
21 |
All |
3 Years to 29 Years (Child, Adult) |
NCT01319864 |
IRB00047475 POETIC Plerixafor |
|
March 2011 |
July 2017 |
July 2017 |
March 22, 2011 |
October 19, 2016 |
|
- Phoenix Children's Hospital
Phoenix, Arizona, United States - The Children's Hospital of Denver
Denver, Colorado, United States - Children's Healthcare of Atlanta/Emory University
Atlanta, Georgia, United States - (and 6 more...)
|
32 |
NCT02921061 |
Recruiting |
Decitabine, Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome |
- Mixed Phenotype Acute Leukemia
- Previously Treated Myelodysplastic Syndrome
- Recurrent Adult Acute Myeloid Leukemia
- (and 4 more...)
|
- Drug: Cladribine
- Drug: Cytarabine
- Drug: Decitabine
- (and 3 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
|
- Determination of Maximum Tolerated Dose (MTD) for decitabine when given together with G-CLAM determined by dose limiting toxicities (DLTs) (Phase I)
- Rate of minimal residual disease negative (MRDneg) complete remission (Phase II)
- Remission (complete remission [CR]/CR with incomplete peripheral blood count recovery [CRi])
- (and 3 more...)
|
41 |
All |
18 Years and older (Adult, Senior) |
NCT02921061 |
9713 NCI-2016-01401 P30CA015704 |
|
November 17, 2016 |
December 15, 2018 |
|
September 30, 2016 |
April 18, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
33 |
NCT02551718 |
Recruiting |
High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia |
- Acute Leukemia of Ambiguous Lineage
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- (and 5 more...)
|
- Other: Chemosensitivity Assay
- Other: Cytology Specimen Collection Procedure
- Genetic: Gene Expression Analysis
- (and 2 more...)
|
Interventional |
Not Applicable |
- University of Washington
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of patients we are able to test and initiate treatment within a 21 day period.
- Rate of complete remission
- Survival
|
25 |
All |
3 Years and older (Child, Adult, Senior) |
NCT02551718 |
9226 NCI-2015-01299 P30CA015704 |
|
September 11, 2015 |
July 1, 2019 |
|
September 16, 2015 |
March 1, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
34 |
NCT01371656 |
Completed |
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation |
- Acute Leukemias of Ambiguous Lineage
- Bacterial Infection
- Diarrhea
- (and 7 more...)
|
|
Interventional |
Phase 3 |
- Children's Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single
- Primary Purpose: Supportive Care
|
- Occurrence of at least 1 episode of true bacteremia among AL and HSCT subjects, respectively
- Susceptibility of E. coli, K. pneumoniae, and P. aeruginosa stool or peri-rectal swab isolates to cefepime, imipenem, and levofloxacin
- Susceptibility of S. mitis peri-rectal swab isolates to cefepime, levofloxacin, and penicillin
- (and 10 more...)
|
740 |
All |
6 Months to 21 Years (Child, Adult) |
NCT01371656 |
ACCL0934 NCI-2011-02636 CDR0000695661 COG-ACCL0934 U10CA095861 |
|
September 2011 |
June 2017 |
June 2017 |
June 13, 2011 |
February 19, 2018 |
|
- Arkansas Children's Hospital
Little Rock, Arkansas, United States - Southern California Permanente Medical Group
Downey, California, United States - City of Hope Medical Center
Duarte, California, United States - (and 81 more...)
|
35 |
NCT00933985 |
Terminated |
Obatoclax Mesylate, Vincristine Sulfate, Doxorubicin Hydrochloride, and Dexrazoxane Hydrochloride in Treating Young Patients With Relapsed or Refractory Solid Tumors, Lymphoma, or Leukemia |
- Acute Leukemias of Ambiguous Lineage
- Acute Undifferentiated Leukemia
- Angioimmunoblastic T-cell Lymphoma
- (and 26 more...)
|
- Drug: dexrazoxane hydrochloride
- Drug: doxorubicin hydrochloride
- Drug: obatoclax mesylate
- (and 3 more...)
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum-tolerated dose of obatoclax mesylate in combination with vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane hydrochloride, defined as the maximum dose at which fewer than one-third of patients experience dose limiting toxicity
- Incidence of adverse events characterized by grade, relationship to study therapy, and prior experience, assessed by NCI CTCAE v4.0
- Disease response assessed using Response Evaluation Criteria in Solid Tumors
|
22 |
All |
up to 21 Years (Child, Adult) |
NCT00933985 |
NCI-2011-01936 COG-ADVL0816 CDR0000647160 ADVL0816 U01CA097452 |
|
June 2009 |
April 2013 |
April 2013 |
July 8, 2009 |
May 1, 2014 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Childrens Hospital of Orange County
Orange, California, United States - Children's National Medical Center
Washington, District of Columbia, United States - (and 17 more...)
|
36 |
NCT01231919 |
Completed |
MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia |
- Accelerated Phase Chronic Myelogenous Leukemia
- Acute Leukemias of Ambiguous Lineage
- Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
- (and 48 more...)
|
- Drug: Akt inhibitor MK2206
- Other: diagnostic laboratory biomarker analysis
- Other: pharmacological study
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MTD and/or recommended phase 2 dose of Akt inhibitor MK2206 determined according to incidence of dose-limiting toxicities (DLTs) graded using CTCAE v4.0 (Part A)
- Pharmacokinetic (PK) parameters of Akt inhibitor MK-2206
- Antitumor activity assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1
- (and 2 more...)
|
45 |
All |
1 Year to 21 Years (Child, Adult) |
NCT01231919 |
NCI-2011-02612 CDR0000687929 COG-ADVL1013 ADVL1013 U01CA097452 |
|
January 2011 |
April 2013 |
|
November 1, 2010 |
April 29, 2014 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Childrens Hospital of Orange County
Orange, California, United States - University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States - (and 22 more...)
|
37 |
NCT00013533 |
Completed |
Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies |
- Hodgkin Lymphoma
- Lymphocytic Leukemia
- Mixed Cell Leukemia
- (and 6 more...)
|
- Procedure: Stem cell transplantation
|
Interventional |
Early Phase 1 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the efficacy and safety of this chemotherapy regimen in facilitating donor engraftment after allogeneic bone marrow transplantation (BMT).
- Safety/Efficacy
- Toxicity of regimen
- (and 8 more...)
|
30 |
All |
4 Years to 20 Years (Child, Adult) |
NCT00013533 |
010125 01-C-0125 |
|
March 14, 2001 |
March 1, 2008 |
May 7, 2015 |
March 21, 2001 |
April 24, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
38 |
NCT00723099 |
Recruiting |
Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer |
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Aggressive Non-Hodgkin Lymphoma
- (and 23 more...)
|
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Cyclophosphamide
- Drug: Cyclosporine
- (and 5 more...)
|
Interventional |
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
|
- Overall survival
- Incidence of chronic GVHD for each arm
- Incidence of clinically significant infections
- (and 7 more...)
|
76 |
All |
up to 69 Years (Child, Adult, Senior) |
NCT00723099 |
2239.00 NCI-2009-01551 2239 P30CA015704 |
|
June 25, 2008 |
November 13, 2018 |
November 13, 2019 |
July 28, 2008 |
January 19, 2018 |
|
- University of Colorado Hospital
Aurora, Colorado, United States - Colorado Blood Cancer Institute
Denver, Colorado, United States - LDS Hospital
Salt Lake City, Utah, United States - (and 3 more...)
|
39 |
NCT01431664 |
Completed |
AT9283 in Treating Young Patients With Relapsed or Refractory Acute Leukemia |
|
- Drug: multikinase inhibitor AT9283
- Other: laboratory biomarker analysis
- Other: pharmacological study
|
Interventional |
Phase 1 |
|
Other |
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum-tolerated dose and recommended phase II dose of multikinase inhibitor AT9283
- Adverse events to multikinase inhibitor AT9283 and grading severity according to NCI CTCAE Version 4.02
- Partial remission, complete remission, or complete remission with incomplete bone marrow recovery using disease-specific criteria based on ANC, platelets, and % blasts in the bone marrow
- (and 3 more...)
|
7 |
All |
up to 18 Years (Child, Adult) |
NCT01431664 |
CDR0000709775 CRUK-CR0708-12 EUDRACT-2009-016952-36 |
|
September 2011 |
July 2014 |
July 2014 |
September 9, 2011 |
December 2, 2014 |
|
- Royal Marsden Hospital
Surrey, London, United Kingdom - Birmingham Children's Hospital
Birmingham,, United Kingdom - Leeds General Infirmary
Leeds, United Kingdom - (and 2 more...)
|
40 |
NCT00990249 |
Completed |
Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation |
- Leukemia
- Lymphoma
- Allogeneic Haematopoietic Stem Cell Transplantation
- Acute Lymphoblastic Leukemia
|
- Drug: Busulfan
- Drug: Clofarabine
- Drug: Thymoglobulin
- Procedure: Stem Cell Transplant
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment-Related Mortality (TRM)
|
120 |
All |
up to 65 Years (Child, Adult) |
NCT00990249 |
2009-0209 NCI-2012-01270 |
|
October 2009 |
May 2016 |
May 2016 |
October 6, 2009 |
May 12, 2016 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
41 |
NCT02115295 |
Recruiting |
Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With Acute Myeloid Leukemia (AML), High Risk Myelodysplastic Syndrome (HR MDS) or Myeloid Blast Phase of Chronic Myeloid Leukemia (CML) |
|
- Drug: Cladribine
- Drug: Cytarabine
- Drug: Idarubicin
- Behavioral: Phone Calls
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete Response Rate (CR)
- Overall Response Rate (ORR)
|
308 |
All |
18 Years to 65 Years (Adult) |
NCT02115295 |
2012-0648 NCI-2014-01103 |
|
May 2014 |
May 2019 |
May 2019 |
April 16, 2014 |
June 23, 2017 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
42 |
NCT02718755 |
Not yet recruiting |
Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies |
|
- Drug: Fludarabine
- Drug: Cytarabine
- Drug: Erwinase
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
- Jazz Pharmaceuticals
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
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- Overall Response of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies
- Disease-Free Survival (DFS) of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies
|
20 |
All |
18 Years to 60 Years (Adult) |
NCT02718755 |
2015-0807 NCI-2016-00691 |
|
May 2018 |
May 2021 |
May 2022 |
March 24, 2016 |
March 14, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|