Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

NCT02635984 | Completed Phase 3 Results DMC

• 1 other identifier: 818888
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the effectiveness of olanzapine added to standard triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients receiving highly or moderately emetogenic chemotherapy regimens.

Conditions

Complications of Bone Marrow Transplant; Hematologic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Percentage of Patients Who Had a Complete Response

  Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (\< 25 mm on a 100 mm visual analog scale \[VAS\]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.

  Until study completion; estimated 1.5 years

Secondary Outcomes (7)

• Percent of Patients With no Significant Nausea in Overall Assessment Period

  Until study completion; estimated 1.5 years

• Percent of Patients Achieving Complete Protection in Overall Assessment Phase

  Until study completion; estimated 1.5 years

• Percent of Participants With no Significant Nausea in Acute Phase

  Until study completion; estimated 1.5 years

• Percent of Participants With no Significant Nausea in Delayed Phase

  Until study completion; estimated 1.5 years

• Percent of Patients With no Nausea in Overall Assessment Period

  Until study completion; estimated 1.5 years

Study Arms (2)

Triplet Therapy Plus Placebo

PLACEBO COMPARATOR

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Drug: Placebo

Triplet Therapy Plus Olanzapine

ACTIVE COMPARATOR

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Drug: Olanzapine

Interventions

Olanzapine DRUG

Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Also known as: Zyprexa

Triplet Therapy Plus Olanzapine

Placebo DRUG

Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

Triplet Therapy Plus Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatient or outpatient hematology patient receiving one of the following regimens:
• Chemotherapy for hematologic malignancy:
• ABVD
• ICE ± R
• Conditioning therapy for stem cell transplantation:
• BEAM
• Bu/Cy ± ATG
• Bu/Flu ± ATG
• FluCy ± ATG
• FluCy + TBI
• BuMel
• FluBuCy
• Melphalan
• Etoposide + TBI
• Cyclophosphamide + TBI

You may not qualify if:

• Allergy to olanzapine
• Documented nausea or vomiting ≤24 hours prior to enrollment
• Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to enrollment or planned during protocol therapy
• Chronic alcoholism
• Pregnant
• Declined or unable to provide an informed consent

Sponsors & Collaborators

• Augusta University: lead
• University of Georgia: collaborator

Study Sites (1)

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

• Clemmons AB, Orr J, Andrick B, Gandhi A, Sportes C, DeRemer D. Randomized, Placebo-Controlled, Phase III Trial of Fosaprepitant, Ondansetron, Dexamethasone (FOND) Versus FOND Plus Olanzapine (FOND-O) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Hematologic Malignancies Receiving Highly Emetogenic Chemotherapy and Hematopoietic Cell Transplantation Regimens: The FOND-O Trial. Biol Blood Marrow Transplant. 2018 Oct;24(10):2065-2071. doi: 10.1016/j.bbmt.2018.06.005. Epub 2018 Jun 13.

  PMID: 29906570 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Amber Clemmons, Clinical Pharmacist - BMT/Hematology & Clinical Associate Professor
• Organization: AU Medical Center / University of Georgia College of Pharmacy

aclemmons@augusta.edu

706-721-6493

Study Officials

• Amber B Clemmons, PharmD

  Augusta University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 21, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 20, 2018
• Results First Posted: August 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)