Phase 3
Completed N=108
Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens
Complications of Bone Marrow Transplant · Hematologic Neoplasms
Source: ClinicalTrials.gov NCT02635984 ↗
Enrolled (actual)
108
Serious AEs
—
Results posted
Aug 2018
Primary outcomePrimary: Overall Percentage of Patients Who Had a Complete Response — 13; 28 Participants — p=0.003
◆ Published Evidence
Established
55citations · ~7 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Percentage of Patients Who Had a Complete Response |
13; 28 | 0.003 sig |
| SECONDARY Percent of Patients With no Significant Nausea in Overall Assessment Period |
14; 30 | 0.001 sig |
| SECONDARY Percent of Patients Achieving Complete Protection in Overall Assessment Phase |
6; 13 | 0.11 |
| SECONDARY Percent of Participants With no Significant Nausea in Acute Phase |
33; 39 | 0.28 |
| SECONDARY Percent of Participants With no Significant Nausea in Delayed Phase |
16; 34 | 0.002 sig |
| SECONDARY Percent of Patients With no Nausea in Overall Assessment Period |
6; 18 | 0.006 sig |
| SECONDARY Percent of Patients With Complete Response in Acute Phase |
31; 39 | 0.13 |
| SECONDARY Percent of Patients With Complete Response in Delayed Phase |
15; 31 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Inpatient or outpatient hematology patient receiving one of the following regimens:
- Chemotherapy for hematologic malignancy:
- ABVD
- ICE ± R
- 7+3
- Conditioning therapy for stem cell transplantation:
- BEAM
- Bu/Cy ± ATG
- Bu/Flu ± ATG
- FluCy ± ATG
- FluCy + TBI
- BuMel
- FluBuCy
- Melphalan
- Etoposide + TBI
- Cyclophosphamide + TBI
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02635984) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.