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Complications of Bone Marrow TransplantPhase 3FOND-ONCT02635984

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

A Phase 3 study testing Olanzapine in people with Complications of Bone Marrow Transplant and Hematologic Neoplasms, run by Augusta University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Olanzapine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
1 siteUnited States
Study dates
Nov 2015to Dec 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 16Show fewer
  • BEAM
  • Bu/Cy ± ATG
  • Bu/Flu ± ATG
  • FluCy ± ATG
  • FluCy + TBI
  • BuMel
  • FluBuCy
  • Melphalan
  • Etoposide + TBI
  • Cyclophosphamide + TBI

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Augusta University Medical Center

    Augusta, Georgia, 30912

Other trials in United States

About this study

Official title: Randomized, Placebo Controlled Study of FOND (Fosaprepitant, Ondansetron, Dexamethasone) Versus FOND+O (FOND Plus Olanzapine) for the Prevention of Chemotherapy Induced Nausea and Vomiting in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

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.

Read the detailed description

Nausea and vomiting remains a common and difficult to manage consequence of chemotherapy despite prophylaxis. These symptoms can often lead to a decreased quality of life, dehydration, and malnutrition. Olanzapine is an atypical antipsychotic that blocks multiple neuronal receptors involved in nausea/vomiting pathways. Olanzapine has been studied for breakthrough chemo-induced nausea and vomiting (CINV) as well as in prophylaxis of highly and moderately emetogenic regimens (HEC and MEC, respectively). However, these studies have focused on patients with solid tumor malignancies and chemotherapy regimens of short duration. To date, no publications have reported outcomes from adding olanzapine to standard triplet therapy, for hematology patients, including those undergoing hematopoietic stem cell transplants and those who receive multi-day HEC and MEC regimens.

This is a blinded, placebo controlled trial randomizing patients to receive olanzapine 10 mg orally on all chemotherapy days plus three additional days post chemotherapy or placebo in addition to standard triplet therapy (ondansetron and dexamethasone on each day of chemotherapy and fosaprepitant 150 mg IV on day one of chemotherapy). Inclusion criteria: age 18 or older, receiving inpatient or outpatient HEC or MEC chemotherapy including those regimens given before stem cell transplantation (ABVD, ICE ± R, 7+3 or 5+2, BEAM, Bu/Cy ± ATG, Bu/Flu ± ATG, FluCy ± ATG, BuMel, FluBuCy, Melphalan). Exclusion criteria: allergy to olanzapine, documented nausea/vomiting ≤24 hours before enrollment, treatment with other antipsychotic agents, or declined informed consent. Patients will be randomized to placebo or olanzapine in a block design stratified by chemotherapy type (transplant conditioning vs. chemotherapy only) and number of days of chemotherapy (single vs. multi-day) by the Investigational Drug Pharmacy services at Augusta University Medical Center.

Being tested
Olanzapine, Placebo
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlanzapineDrug

    Also called Zyprexa

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

  • PlaceboDrug

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

Study groups in NCT02635984
Study groupRoleWhat they receive
Triplet Therapy Plus PlaceboPlacebo comparatorAll 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.
Receives: Drug: Placebo
Triplet Therapy Plus OlanzapineActive comparatorAll 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.
Receives: Drug: Olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Until study completion; estimated 1.5 years

Secondary outcomes (7)

  1. Percent of Patients With no Significant Nausea in Overall Assessment Period

    Reported for overall phases [chemotherapy days plus 5 days after] where all VAS < 25 mm

    Measured: Until study completion; estimated 1.5 years

  2. Percent of Patients Achieving Complete Protection in Overall Assessment Phase

    (CP = no emesis, no breakthrough antiemetic use, no significant nausea). To be reported as overall phases [chemotherapy days plus 5 days after]

    Measured: Until study completion; estimated 1.5 years

  3. Percent of Participants With no Significant Nausea in Acute Phase

    Reported as acute [chemotherapy days]. All assessment with all VAS < 25 mm on days of chemotherapy

    Measured: Until study completion; estimated 1.5 years

  4. Percent of Participants With no Significant Nausea in Delayed Phase

    Reported for delayed [5 days after chemotherapy administration] All assessment with all VAS < 25 mm

    Measured: Until study completion; estimated 1.5 years

  5. Percent of Patients With no Nausea in Overall Assessment Period

    No nausea (all VAS <5 mm) in overall assessment period (days of chemotherapy plus five days after)

    Measured: Until study completion; estimated 1.5 years

  6. Percent of Patients With Complete Response in Acute Phase

    Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in acute phase (days of chemotherapy)

    Measured: Until study completion; estimated 1.5 years

  7. Percent of Patients With Complete Response in Delayed Phase

    Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in delayed phase (5 days after chemotherapy)

    Measured: Until study completion; estimated 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02635984
Sponsor's protocol ID
818888
Acronym
FOND-O
Status last verified
Jul 2018
First submitted
15 Dec 2015
Last updated
20 Aug 2018
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 29906570

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olanzapine in people with Complications of Bone Marrow Transplant and Hematologic Neoplasms, run by Augusta University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Percentage of Patients Who Had a Complete Response (time frame: Until study completion; estimated 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02635984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.

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