Dose Escalation and Cohort Expansion Study of TEN-010 in Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome

The Weill Cornell Leukemia Program has recently opened a new clinical trial for men and women who have been diagnosed with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). The study sponsor is Tensha Therapeutics, Inc. and the principal investigator at Weill Cornell is Dr. Gail Roboz. For more information about the study, please call Tania Curcio, RN at (212) 746-2571 or e-mail tjc9003@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older with a confirmed diagnosis of AML or MDS
  • Previously treated with at least one prior therapy
  • Subjects with a history of allogeneic (from another person) stem cell transplant are eligible for study participation
  • Life expectancy of at least 2 months
  • Detailed eligibility reviewed when you contact the study team

Study Details

This is a Phase 1, non-randomized, open-label, multi-center study that utilizes the investigational study drug TEN-010. TEN-010 belongs to a group of drugs called bromodomain inhibitors.  Bromodomains are found in cancer cells and bromodomain inhibitors may have promise as a therapy for patients who have cancer.  Currently, there are no bromodomain inhibitors approved by the FDA for humans. Research in the laboratory has shown that TEN 010 kills cancer cells in different types of both blood cancers.

The study is conducted in two parts; Part A and Part B. In Part A, escalating doses of TEN-010 will be administered to patients to evaluate safety and side effects that may limit the amount of TEN-010 given to patients. One of the goals of Part A is to establish the maximum tolerated dose (MTD) of TEN-010. Part B is an expansion study in which patients are treated at the MTD of TEN-010 to identify safety, tolerability, and how well the disease responds to treatment with TEN-010.

All subjects participating in this study will receive the study drug TEN-010 once daily. Subjects will be assigned to one of three different dose levels ranging from 0.06 mg/kg to 0.24 mg/kg .


New Clinical Trial: Randomized, Open Label, Phase 2 Study of Selinexor (KPT-330) vs Physician’s Choice in Patients Greater Than or Equal to 60 Years Old with Relapsed/Refractory Acute Myeloid Leukemia (AML) who are Ineligible for Intensive Chemotherapy and/or Transplant

The Weill Cornell Leukemia Program has recently opened a new clinical trial for men and women who have been diagnosed with Acute Myeloid Leukemia (AML). The study sponsor is Karyopharm Therapeutics and the principal investigator at Weill Cornell is Dr. Gail Roboz. For more information about the study, please call Tania Curcio, RN at (212) 746-2571 or e-mail tjc9003@med.cornell.edu.

Key Eligibility

  • Men and women age 60 and older with a confirmed diagnosis of AML
  • Previously treated with at least one prior therapy
  • Have not undergone and currently  ineligible for stem cell transplant and/or intensive chemotherapy
  • Have not been diagnosed with Acute Promyelotic Leukemia (AML M3),  Chronic Myeloid Leukemia (CML), and Central Nervous System Leukemia
  • Detailed eligibility reviewed when you contact the study team

Study Details

This randomized, open label study has been designed to assess whether Selinexor (KPT-330) can improve the overall survival in patients with relapsed or refractory AML who are not candidates for intensive chemotherapy. Selinexor (KPT-330) works by trapping “tumor suppressing proteins” within the cell and thus causing the cancer cells to die or stop growing.  The study drug has previously been tested in humans to define a safe dose to be administered. Selinexor is currently being tested in other clinical trials in patients with advanced cancers. This study will examine the effects of Selinexor on AML and the side effects that may occur as a result of treatment. It will also compare the effect of Selinexor with the effect of other existing treatments for AML that your physician can recommend.

Potential subjects will be enrolled in of two treatment groups:
Treatment group 1: In group 1, KPT-330 will be given orally (by mouth) twice weekly
Treatment group 2: In group 2, your physician will choose one of the following AML treatments that are currently available:

  • Best supportive care (BSC) including blood product transfusions, antimicrobial drugs, growth factors as needed, and hydroxyurea
  • BSC + low dose Ara-C given twice a day by subcutaneous injection
  • BSC + hypomethylating agent azacitidine given by subcutaneous injection or decitabine administered intravenously

Selinexor will be given orally twice weekly (Monday and Wednesday or Tuesday and Thursday) at a dose of 60-120 mg


Dr. Gail Roboz reviews existing and evolving approaches to the treatment of patients with AML for Medscape Education

Medscape AML Presentation  To view the entire presentation and slideshow, click here.


Weill Cornell Cancer Center Highlighted in New York Times

cancer-1-articleLarge   An April 21, 2013 article in the New York Times describes the budding field of Precision Medicine.  The article highlights Weill Cornell’s state-of-the-art Cancer Center and how Precision Medicine is being used to treat patients with Leukemia.  To read the full article, click here.


Targeted Healthcare interviews Dr. Gail Roboz on improving the standard treatment of AML

To view the video, click here.

Targeted Healthdare Interview


New Clinical Trial: Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

The Weill Cornell Leukemia Program is now recruiting patients for a new study, “CALGB 10801: A Phase II Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy Plus Dasatinib and Continuation Therapy with Dasatinib Alone in Newly Diagnosed Patients with Core Binding Factor Acute Myeloid Leukemia (AML).”

The physician leading the study at Weill Cornell is Gail Roboz, MD. For more information or to see if you are eligible for the study, please contact Tania Curcio, RN at (212) 746-2571 or email Tania at tjc9003@med.cornell.edu.

Study details:

This is a clinical trial for patients with acute myeloid leukemia (AML) that possesses an abnormal molecular feature (a gene mutation). The purpose of this study is to test the safety and effectiveness of adding the drug dasatinib to a treatment regimen in patients with AML and to determine how well the leukemia responds to the treatment. The study is being done because currently available treatment is not effective in curing patients with this type of leukemia.

There are three parts to the treatment in this study. The first part of the therapy will test the safety and effectiveness of adding dasatinib to the standard combination of chemotherapy drugs used to treat AML that include daunorubicin and cytarabine. The second part of the therapy will test the safety and effectiveness of combining dasatinib with another chemotherapy treatment, consolidation therapy with high-dose cytarabine. Finally, the third part of the therapy will test the effectiveness of the use of dasatinib alone for 12 months during continuation therapy.

Patients will receive therapy for about 18 months on study. After you are finished with the therapy, you will be asked to visit the office for follow-up at least every 2 months for 2 years, then every 3 months for 2 years, then yearly for a maximum of 10 years from when you entered the study.

Key Eligibility
  • Men and women age 18 and older
  • Acute myeloid leukemia (AML with Core Binding Factor (CBF) abnormality
  • No prior chemotherapy for leukemia or myelodysplasia
  • Detailed eligibility reviewed when you contact the study team

Dr. Roboz Speaks on Genomics in AML

Dr. Gail Roboz spoke with ecancertv at ASH 2011 in San Diego about the major genomic research on acute myeloid leukaemia.  There has been a lot of recent success on identifying mutations and abnormalities in AML; however, Prof Roboz believes that the discovery period with genomic research is coming to an end and a move towards clinical trials and targeted therapies need to be developed.  The largest development has been the role of stems cell in research and how to target the cells that are left over after chemotherapy.

Roboz ecancer.tv