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Eric Drew posted an update in the group Acute Myeloid Leukemia AML Advocate Network
For AML patient who relapsed after allogenic transplant, the LLS has outlined these trials which is a valuable list for anyone with relapsed AML!!! Thank you for sharing!!!!
NCT Number Title Phases Locations
These first three trials are located in Florida:
NCT02587598 Study of INCB053914 in Subjects With Advanced Malignancies
Phase 1|Phase 2 Multiple locations including Mayo Clinic Jacksonville FL & Florida Cancer Specialists & Research Institute in Sarasota FL
NCT02113982 SL-401 in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia
Phase 1|Phase 2 Multiple locations including H.Lee Moffitt Cancer Center & Research Institute Tampa FL
NCT02576301 Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS (AML)
Phase 1/Phase 2 **Phase 2 (expansion) patients eligible if they have relapsed AML
Located at University of Florida in Gainesville and U. of Miami in Miami FL
The following trials are located at MD Anderson in Houston TX:
NCT02953561 Avelumab (antiPDL1) and Azacytidine in Acute Myeloid Leukemia (AML)
Phase 1|Phase 2 MD Anderson TX
NCT02488408 A Phase Ib/II Multicenter Open-label Study of BGB324 in Patients With AML or MDS
Phase 1|Phase 2 MD Anderson TX, Iowa & Ohio
NCT02399917 An Open-label Study of Lirilumab (BMS-986015) in Combination With 5-azacytidine (Vidaza) for the Treatment of Patients With Refractory/ Relapsed Acute Myeloid Leukemia
Phase 2 MD Anderson TX
NCT02397720 Study of Nivolumab (BMS-936558) in Combination With 5-azacytidine (Vidaza) or Nivolumab With Ipilimumab in Combination With 5-azacytidine for Patients With Refractory/ Relapsed Acute Myeloid Leukemia (AML)
Phase 2 MD Anderson TX
NCT02392572 ONC201 in Relapsed/Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes (HR-MDS)
Phase 1|Phase 2 MD Anderson TX
NCT02397720 Study of Nivolumab (BMS-936558) in Combination With 5-azacytidine (Vidaza) or Nivolumab With Ipilimumab in Combination With 5-azacytidine for Patients With Refractory/ Relapsed Acute Myeloid Leukemia (AML) Phase 2 MD Anderson TX
NCT02392572 ONC201 in Relapsed/Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes (HR-MDS)
Phase 1|Phase 2 MD Anderson TX
NCT02190695 Leukemia SPORE Phase II 3-arm DAC Randomized Study for R/R and Elderly Acute AML and MDS Phase 2 MD Anderson TX & Temple in PA
Located in other areas:
NCT01620216 Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Phase 2 NIH in MD, Oregon, UT Southwestern in TX & Utah
NCT02768792 High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML
Phase 2 John Hopkins & North Carolina
Relapse post-transplant trial
NCT02583893 Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
Phase 2 Located at Thomas Jefferson University in PA
NCT02484391 CIP-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma
Phase 2 Cancer Center of Wake Forest University in NC
NCT02337478 Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 2 Wake Forest University in NC
NCT02109744 Study of Decitabine in Combination With Sequential Rapamycin or Ribavirin in High Risk AML Patients
Phase 1|Phase 2 Rochester NY
NCT02044796 Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
Phase 1|Phase 2 Fred Hutch in WA
NCT01787474 IL-21-Expanded NK Cells for Induction of Acute Myeloid Leukemia (AML)
Phase 1|Phase 2 U. of Texas
NCT02509546 8-Chloro-Adenosine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase 1|Phase 2 City of Hope CAA clinical trial is a carefully controlled research study conducted by doctors to improve the care and treatment of people with cancer or other illnesses. You can find more information at these links:
• Clinical Trials: http://www.lls.org/treatment/types-of-treatment/clinical-trials
• LLS booklet, Understanding Clinical Trials for Blood Cancers: http://www.lls.org/sites/default/files/file_assets/understandingclinicaltrials.pdf
• Questions to Ask Your Healthcare Provider About Clinical Trials: http://www.lls.org/sites/default/files/National/USA/Pdf/clinical%20Questionaire2012.pdf
Recent Activity In Acute Myeloid Leukemia AML Advocate Network
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8Ting posted an update in the group Acute Myeloid Leukemia AML Advocate Network
I am looking for information regarding the safety and efficacy of using Zarxio in improving WBC situation after chemo to treat Myeloid for a friend, His doctor suggested starting Zarxio inject but did not give much more about why and how effective it has been and what is the side effect. If anyone here knows more and can share, that will be great.
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Thank you very much 8Ting for reaching out. I do not have personal experience with this drug, but WeHeal partners with other organizations to make sure you find the answer you need. I did find some answers at the link attached, but you may also want to contact one of the advocates at our partner Cancer Commons (CancerCommons.org). Just go to the patients tab and fill out the ASK form, and one of the advocates there will respond and hopefully will be able to give you more details. The leukemia lymphoma society also has an advocate center, and often contacting the pharma company who makes the drug can be the best source of info. https://www.everydayhealth.com/drugs/filgrastim
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8Ting joined the group Acute Myeloid Leukemia AML Advocate Network
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Jeff Jones posted an update in the group Acute Myeloid Leukemia AML Advocate Network
Do you have or know someone who is a Sibling who has found the battle: “Oh Brother: Being the Sibling of a Kid With Cancer” :
Oh Brother: Being the Sibling of a Kid With Cancer – The Seany FoundationOh Brother: Being the Sibling of a Kid With Cancer – The Seany Foundation -
Eric Drew posted an update in the group Acute Myeloid Leukemia AML Advocate Network
Improved Survival With Integration of Chinese Herbal Medicine Therapy in Patients With Acute Myeloid Leukemia: A Nationwide Population-Based Cohort StudyIntegrative Cancer Therapies – Tom Fleischer, Tung-Ti Chang, Jen-Huai Chiang, Mao-Feng Sun, Hung-Rong Yen, 2017Purpose. Acute myeloid leukemia (AML) is the most deadly subtype of leukemia, and many patients with this disease seek other complementary therapies, one of whi… -
DocT posted an update in the group Acute Myeloid Leukemia AML Advocate Network
Hoping vitamin D (in high doses) will have an inhibitory effect on AML cell proliferation, as this 2013 article states, ” these data suggest that 25(OH) vitamin D3 exerts both direct anti-proliferative effects on leukemia cells and direct/indirect leukemia inhibitory microenvironment reprograming activities”
25(OH) Vitamin D3 Affects Acute Myeloid Leukemia Cell Proliferation | Blood JournalWe recently demonstrated that acute myeloid leukemia (AML) patients with insufficient serum 25(OH) vitamin D3 levels had a worse outcome following intensive induction therapy. However, the mechanisms by which 25(OH) vitamin D3 and its metabolites exert these effects are poorly understood. We utilized in vitro systems with orthogonal genomic and computational approaches to delineate leukemia-specific vitamin D molecular targets that may contribute to its activities. To achieve this goal, we systematically investigated vitamin D anti-proliferative effects using a genomically-annotated panel of human leukemia cell lines, including lines with genetic alterations that are commonly observed in patients. Since the genetic diversity of these cell lines reflects many of the alterations found in AML patients, we hypothesized that they collectively represent a model system to replicate candidate anti-leukemia drug effects. Specifically, we cultured 40 leukemia cell lines with and without 25(OH) vitamin D3 in a dose- and time-dependent manner for 72 hours and used high-throughput (HT) cell-based assays to simultaneously measure multiple modalities/ parameters related to cell proliferation and cytotoxicity (i.e. combining several HT assay chemistries to simultaneously assess cell number, viability, cytotoxicity and caspase activation events). Six AML cell lines (THP-1, MV4;11, MOLM-6, MOLM-13, EOL-1, JK-1) that responded to 25(OH) vitamin D3 treatment were identified and selected for multi-parametric RNA-Seq studies (NB 200nM Vitamin D treatment or vehicle control for 24 hours). Total RNA was extracted and analyzed by the Illumina HiSeq 2500 sequencing platform and mRNA, microRNA and ncRNAs were unambiguously quantitated. Utilizing gene expression profiles and in silico computational modeling of canonical or putative vitamin D receptor elements (VDRE) transcription factor promoter binding sites, we (1) identified a conserved/core gene transcriptional signature and (2) subsequently developed a vitamin D – genetic inference model. Gene enrichment analysis of the inferred network model identified genes involved in abnormal hematopoiesis, proliferation and differentiation, interleukin secretion, leukocyte migration, and bone marrow cell morphology and/or development. Notably, our data identified several 25(OH) vitamin D3 transcriptional regulatory cascades that converge on ETS2, JUND, NCOA4, RXR4, WT1, and ZFP30 transcription factors. Furthermore, we also demonstrate temporal and spatial regulation of protein kinases CAMK1 and FGFR, cytokine and growth factors (cAMP, CCL2, IL-8 and TNF), and cell differentiation markers (CD14, CD97, FCGR2A, IL3RG, IL7R, ITGAM, THBD). In summary, these data suggest that 25(OH) vitamin D3 exerts both direct anti-proliferative effects on leukemia cells and direct/indirect leukemia inhibitory microenvironment reprograming activities and better clarify the complex molecular mechanisms underlying the therapeutic activity of 25(OH) vitamin D3 in AML.Disclosures: No relevant conflicts of interest to declare.
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Thanks DocT for posting this, and please let us know how the study turns out! Our goal is to make this data available for all AML treatment providers, patients, and researchers! We will be organizing an oversight committee for this community to do just that!
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I thought it would be valuable for any AML patients considering treatment options to have the full correspondence form the LLS.
You would like to stay in Florida, but you are willing to travel if needed. I have done a clinical trial search for relapsed AML throughout the US. You will find my results below and also attached in a Word document. There are many clinical trials that are available for relapsed AML. As you will see, I have sorted them into three different groups. The first group are trials that are located in Florida. The second section includes clinical trials located at MD Anderson. The third section are trials located in other parts of the US. As we discussed, I have eliminated early Phase 1 clinical trials.
To access information about a particular trial, right click on the title of the trial and ‘open hyperlink’. This will bring you to a brief description; a list of centers where the trial is taking place; and some general information about the protocol. If you are interested in one of these trials and there is not specific information about the site, let me know and I can research that information for you.
NCT Number Title Phases Locations
These first three trials are located in Florida:
NCT02587598 Study of INCB053914 in Subjects With Advanced Malignancies
Phase 1|Phase 2 Multiple locations including Mayo Clinic Jacksonville FL & Florida Cancer Specialists & Research Institute in Sarasota FL
NCT02113982 SL-401 in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia
Phase 1|Phase 2 Multiple locations including H.Lee Moffitt Cancer Center & Research Institute Tampa FL
NCT02576301 Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS (AML)
Phase 1/Phase 2 **Phase 2 (expansion) patients eligible if they have relapsed AML
Located at University of Florida in Gainesville and U. of Miami in Miami FL
The following trials are located at MD Anderson in Houston TX:
NCT02953561 Avelumab (antiPDL1) and Azacytidine in Acute Myeloid Leukemia (AML)
Phase 1|Phase 2 MD Anderson TX
NCT02488408 A Phase Ib/II Multicenter Open-label Study of BGB324 in Patients With AML or MDS
Phase 1|Phase 2 MD Anderson TX, Iowa & Ohio
NCT02399917 An Open-label Study of Lirilumab (BMS-986015) in Combination With 5-azacytidine (Vidaza) for the Treatment of Patients With Refractory/ Relapsed Acute Myeloid Leukemia
Phase 2 MD Anderson TX
NCT02397720 Study of Nivolumab (BMS-936558) in Combination With 5-azacytidine (Vidaza) or Nivolumab With Ipilimumab in Combination With 5-azacytidine for Patients With Refractory/ Relapsed Acute Myeloid Leukemia (AML)
Phase 2 MD Anderson TX
NCT02392572 ONC201 in Relapsed/Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes (HR-MDS)
Phase 1|Phase 2 MD Anderson TX
NCT02397720 Study of Nivolumab (BMS-936558) in Combination With 5-azacytidine (Vidaza) or Nivolumab With Ipilimumab in Combination With 5-azacytidine for Patients With Refractory/ Relapsed Acute Myeloid Leukemia (AML) Phase 2 MD Anderson TX
NCT02392572 ONC201 in Relapsed/Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes (HR-MDS)
Phase 1|Phase 2 MD Anderson TX
NCT02190695 Leukemia SPORE Phase II 3-arm DAC Randomized Study for R/R and Elderly Acute AML and MDS Phase 2 MD Anderson TX & Temple in PA
Located in other areas:
NCT01620216 Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Phase 2 NIH in MD, Oregon, UT Southwestern in TX & Utah
NCT02768792 High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML
Phase 2 John Hopkins & North Carolina
Relapse post-transplant trial
NCT02583893 Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
Phase 2 Located at Thomas Jefferson University in PA
NCT02484391 CIP-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma
Phase 2 Cancer Center of Wake Forest University in NC
NCT02337478 Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 2 Wake Forest University in NC
NCT02109744 Study of Decitabine in Combination With Sequential Rapamycin or Ribavirin in High Risk AML Patients
Phase 1|Phase 2 Rochester NY
NCT02044796 Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
Phase 1|Phase 2 Fred Hutch in WA
NCT01787474 IL-21-Expanded NK Cells for Induction of Acute Myeloid Leukemia (AML)
Phase 1|Phase 2 U. of Texas
NCT02509546 8-Chloro-Adenosine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase 1|Phase 2 City of Hope CA
A clinical trial is a carefully controlled research study conducted by doctors to improve the care and treatment of people with cancer or other illnesses. You can find more information at these links:
• Clinical Trials: http://www.lls.org/treatment/types-of-treatment/clinical-trials
• LLS booklet, Understanding Clinical Trials for Blood Cancers: http://www.lls.org/sites/default/files/file_assets/understandingclinicaltrials.pdf
• Questions to Ask Your Healthcare Provider About Clinical Trials: http://www.lls.org/sites/default/files/National/USA/Pdf/clinical%20Questionaire2012.pdf