A Study of the Safety and Effectiveness of Experimental Uproleselan With Chemotherapy for Acute Myeloid Leukemia (blood cancer)

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Age: 18 to 75 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Acute Myeloid Leukemia, Leukemia, cancer
Type: Drug study, Phase 3
Target:
12 Participants
Investigator:
Description
The study medication, uproleselan (GMI-1271), is experimental. That means the FDA has not determined that it is safe and effective for any use, and has not approved it for use in humans.

Uproleselan is being studied to treat different types of cancers found in the blood. Your doctor has prescribed chemotherapy to treat your AML.

Uproleselan or placebo (saline) will be given in addition to the standard chemotherapy your doctor has prescribed. A placebo is a solution that looks like uproleselan but contains no study medication. The use of a placebo helps to make sure that the evaluation of the effectiveness and safety of the study medication are judged fairly. Neither you nor the study staff will know who is taking uproleselan and who is taking placebo. If needed for your safety, the Study Doctor can find out which study treatment you were given.

The purposes of this study are to:
• Test if uproleselan added to standard chemotherapy increases lifespan.

• Test if higher remission numbers occur when uproleselan is added to standard chemotherapy.

• Measure the effect of uproleselan on oral mucositis. Oral mucositis is a complication that leads to ulcers in the mouth that may result in pain and interfere with the ability to eat food and drink liquids.

• Learn about the safety and tolerability of uproleselan when given with standard chemotherapy medicines.

• Find out how much uproleselan is in the blood of study participants after being administered uproleselan.

• Measure the effect of uproleselan on blood tests that measure levels of inflammation (a response of body tissue to injury or irritation) and adhesion (stickiness) of cells in your body.

• Measure if uproleselan has an effect on cancer (AML) cells and early stage blood cells, found in your bone marrow.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • ≥18 years and ≤75 years in age
  • Patients with relapsed or refractory AML
  • No more than one prior stem cell transplant
  • Has not received the chemotherapy regimen to be used for induction on this trial
  • Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial

Exclusion criteria:

  • Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML.
  • Active signs or symptoms of CNS involvement by malignancy.
  • Stem cell transplantation ≤4 months prior to dosing.
  • Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing.
  • Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
  • Inadequate organ function.
  • Abnormal liver function.
  • Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
  • Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).
  • Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
  • Clinically significant cardiovascular disease.
  • Major surgery within 4 weeks of dosing.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You may receive the study drug or placebo for up to 4 cycles. The length of each cycle can vary depending on how long you need to be in the hospital for treatment of AML and the treatment course you are receiving. Once you complete your final cycle you will be followed for survival information.
Recruitment period
From Sept. 10, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Acute Myeloid Leukemia

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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