Olanzapine for Nausea/Vomiting Prophylaxis in Recipients of Hematopoietic Stem Cell Transplants

• Status: Recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to see if olanzapine helps to prevent nausea and/or vomiting (throwing up) when it is added to other medicines in subjects having stem cell transplants. Subjects will either be given olanzapine or an inactive pill (called a placebo) before getting any chemotherapy that is known to cause nausea and vomiting. During the study, the study coordinators will ask the subjects to complete surveys to understand if the patient is having nausea and vomiting, and if so, how bad it is making the patient feel.

This trial will split subjects into two groups: one group will be given an inactive pill (placebo), and the other group will be given the active pill (olanzapine). Study coordinators will collect surveys every morning before chemotherapy and 5 days after the last dose of chemotherapy. These surveys may be given by members of the study team or possibly on a mobile device.

Subjects may benefit from being in this research study because olanzapine may reduce the frequency or severity of chemotherapy-induced nausea and vomiting (CINV). The most common risks of using olanzapine include possibly becoming more tired, mild dizziness, mild low blood pressure, and mild muscle "quivering." Other possible adverse effects include low blood pressure, muscle weakness, increased appetite, weight gain, constipation, and liver function test changes however these risks are less common in subjects with cancer. In addition, there may be a change detected in heart rhythm however subjects will be screened for this ahead of time.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: University of North Carolina, Chapel Hill
• Treatments: Olanzapine

Criteria

Inclusion Criteria:

1. Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.

2. Recipients receiving autologous or allogeneic HCT for any disease

3. Any conditioning chemotherapy regimen considered a standard BMT conditioning regimen

4. ECOG Performance Status of 0-2

5. The subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.

Exclusion Criteria:

1. 1. Patients must not have started conditioning chemotherapy prior to consent. Note:

test dose Busulfan is not part of conditioning chemotherapy

2. Known allergy to olanzapine

3. Baseline QTc >500 msec as calculated by Fridericia formula

4. Patients receiving post-transplant cyclophosphamide as planned GVHD prophylaxis

5. Pregnant or breastfeeding (NOTE: patients pregnant or breast-feeding are not eligible to proceed to transplant).

6. Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.

7. Treatment with any investigational drug within 7 days prior to registration.

8. Subject is receiving prohibited medications (ciprofloxacin or fluvoxamine) that cannot be discontinued/replaced by an alternative therapy.