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Clinical Trials

Leukemia: Myeloid leukemia

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients with Advanced Hematologic Malignancies with an IDH1 and/or IDH2 Mutation

This purpose of this study is to find out how safe and tolerable the study drug AG-881 is in patients with hematological cancers which does not respond to standard treatment. Patients diagnosed with the following types of blood cancers - Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM) Myeloproliferative Neoplasm (MPN) or Angioimmunoblastic T-cell Lymphoma (AITL) may qualify for the study. The main purpose of the study is to identify and test the highest dose of the study drug (AG-881) that can be given safely to patients. This drug is designed to target two proteins known as Isocitrate Dehydrogenase (IDH1 and IDH2), which have been discovered to be critical for cancer cell growth by supporting its enhanced metabolic activity. Researchers have discovered that many types of blood cancers have mutations in this protein that causes it to become overactive. The study will mainly answer the following questions: 1) the maximum dose that can be given to the patient with minimal side effects; 2) the amount of the study drug that gets into the blood stream at different time points and what it does to the body after being taken orally.

Status: PENDING
Principal Investigator: Altman

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

The purpose of this study is twofold. First,to determine if the vaccine, ASP0113, prevents or reduces cytomegalovirus (CMV)infections and complications caused by CMV. Second, to study the safety of the vaccine.

Status: Accepting New Patients
Principal Investigator: Mehta

A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

The purpose of this study is to compare the effects, good and/or bad of three drug combinations on patients and their cancer. The combinations are: 1) daunorubicin plus AraC (called “7+3” treatment), 2) idarubicin plus AraC (called “IA” treatment), and 3) vorinostat added to IA therapy.

Status: Accepting New Patients
Principal Investigator: Altman

A Phase 1b Study of ABT-199 (GDC-0199) in Combination with Azacitidine or Decitabine in Treatment Naïve Subjects with Acute Myelogenous Leukemia Who Are >/= 65 Years of Age and Who Are Not Eligible for Standard Induction Therapy

This research study is evaluating the safety, effectiveness, and pharmacokinetics (how much the drug is absorbed in the body at different times) of an investigational drug called ABT-199 in patients who have not yet been treated for acute myeloid leukemia (AML).

Status: Accepting New Patients
Principal Investigator: Frankfurt

An Open-Label, Phase 1b/2 Study Investigating Recommended Phase 2 Dose, Safety, Tolerability, and Preliminary Efficacy of TAK-659 in Adult Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)

This study is divided into 2 parts. The main purpose of the first part of this study (phase 1b) is to evaluate the side effects and risks of an investigational drug, TAK-659, to identify the highest dose that can be tolerated safely, and to decide upon the recommended dose for the second part of the study. The second part of this study (phase 2) will evaluate how well AML responds to the investigational drug.

Status: Accepting New Patients
Principal Investigator: Kaplan

A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

The purpose of the clinical part of the study is to determine if metformin in combination with cytarabine is safe and effective.

Status: Accepting New Patients
Principal Investigator: Altman

A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839 in Patients with Relapsed and/or Treatment-Refractory Leukemia

The purpose of this study is to evaluate the safety of an investigational drug, CB-839, and to determine the best dose to use for future studies.

Status: Accepting New Patients
Principal Investigator: Frankfurt

A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

The purpose of this study is to evaluate the safety and effectiveness of the drug ASP2215 in patients with either relapsed or refractory acute myeloid leukemia (AML).

Status: Accepting New Patients
Principal Investigator: Altman

An Open-Label Phase 2 Prospective, Randomized, Controlled Study Of CLT-008 Myeloid Progenitor Cells as a Supportive Care Measure During Induction Chemotherapy for Acute Myeloid Leukemia

The purpose of the study is to explore the safety and efficacy of an investigational drug called CLT-008 as an extra supportive care measure after induction chemotherapy for patients with acute myeloid leukemia (AML).

Status: Accepting New Patients
Principal Investigator: Galvin

REDEFINE AYAO: Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology

The purpose of this study is to test an 8-week stress reduction course that is intended to reduce anxiety and improve the quality of life of adolescents and young adults diagnosed with cancer. This study will include a total of 100 participants, all of whom have been diagnosed with cancer.

Status: Accepting New Patients
Principal Investigator: Victorson

A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Cancer Patients with Depression and Anxiety

The purpose of this study is to test the safety and tolerability of left- and right-sided rTMS as a treatment for depression in the cancer population.

Status: Accepting New Patients
Principal Investigator: Dokucu

Modular phase II study to link targeted therapy to patients with pathway activated tumors:Module 6 – BGJ398 for patients with tumors with FGFR genetic alterations

Researchers want to know if BGJ398 is safe and has beneficial effects in people who have different tumor types (cancer), and/or blood malignancies with a FGFR regulated pathway. This pathway is thought to play a role in tumor cell growth as well as in the growth of new blood vessels, which supply the tumor with nutrients and oxygen.

Status: Accepting New Patients
Principal Investigator: Chae

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 7 – Ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1

The purpose of this clinical trial is to study if ceritinib is safe and has beneficial effects in people who have different tumor types (cancer), and/or blood malignancies with an ALK or ROS1 activated pathway.

Status: Accepting New Patients
Principal Investigator: Chae

Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Cancer

The purpose of this research study is to determine a safe dose of the drug Trastuzumab and then determine how effective this treatment is.

Status: Accepting New Patients
Principal Investigator: Raizer

A Phase 1 Study of CSL362 (Anti-IL3Ra / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse

The main purpose of the study is to find out the safety and effectiveness of repeat doses of CSL362 at increasing dose levels.

Status: Accepting New Patients
Principal Investigator: Altman

A Phase 3 Open-Label Randomized Study of Quizartinib (Ac220) Monotherapy versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-Line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

The purpose of this study is to evaluate the effectiveness of quizartinib when it is compared to standard forms of chemotherapy used in treating acute myeloid leukemia (AML).

Status: Accepting New Patients
Principal Investigator: Dinner

A Phase IB Open-Label, Multi-Center, Dose Escalation and Expansion Study of Orally Administered MEK162 Plus BYl719 in Adult Patients with Selected Advanced Solid Tumors

The main purpose of this study is to see what effect, good and/or bad, MEK162 and BYL719 given together has on certain advanced solid tumors.

Status: Accepting New Patients
Principal Investigator: Chae

Extended Duration Varenicline for Smoking among Cancer Patients: A Clinical Trial

The main purpose of this research study is to compare 12 versus 24 weeks of varenicline treatment, also known as Chantix®, for smoking cessation.

Status: Accepting New Patients
Principal Investigator: Hitsman

A Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD

The purpose of a phase 2 study is to determine the efficacy, safety and tolerability of intravenous bortezomib in patients with pulmonary GVHD after allogeneic HSCT.

Status: Accepting New Patients
Principal Investigator: Jain

Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients with Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

The purpose of this study is to find what effects treatment with two drugs has on the body and leukemia.

Status: Accepting New Patients
Principal Investigator: Altman

A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Relapsed/Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic Malignancies

The purpose of this study is to find out the effects, good and bad, that EPZ-5676 has on patients and their cancer.

Status: Accepting New Patients
Principal Investigator: Altman

A Phase IIa, Multicenter, Open-Label Study Designed to Evaluate the Safety and Efficacy of Escalating Doses of BL-8040 in Adult Subjects with Relapsed/Refractory Acute Myeloid Leukemia

The main purpose of the study is to examine the safety and tolerability of BL-8040 when given once daily for two days, followed by five days of combined treatment with BL-8040 and Ara-C.

Status: Accepting New Patients
Principal Investigator: Altman

A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia

The purpose of this research study is three-fold: to identify the maximum tolerated dose, that is, the highest dose of the study drug that does not cause unacceptable side effects; to obtain information on the safety and effectiveness in people given the study drug alone; and to measure and evaluate the behavior of the study drug in the blood.

Status: Accepting New Patients
Principal Investigator: Altman

last updated: Mon - August 31, 2015 - 02:54 PM

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