Accelerated Phase Chronic Myelogenous LeukemiaPhase 2NCT00795769
Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant
A Phase 2 study testing ondansetron, survey administration and management of therapy complications in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Lymphoblastic Leukemia in Remission, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant. PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission
- What is being tested?
- ondansetron, survey administration and management of therapy complications
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2008to 10 Jun 2009
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Autologous PBSC transplant patient
- English-speaking
- Planned cryopreserved PBSC infusion at the SCCA outpatient clinic
Who cannot join
- History of prior autologous transplant
- Non-English-speaking
- Planned cryopreserved PBSC infusion at the UWMC inpatient unit
- Infusion of cryopreserved PBSC that are thawed and washed to remove DMSO prior to infusion
- Allergy or adverse reaction to ondansetron
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells
RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant.
PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant.
Read the detailed description
OBJECTIVES:
- To determine whether the incidence of nausea and vomiting related to administration of autologous hematopoetic stem cells cryopreserved in DMSO can be reduced by the use of a single dose of intravenous ondansetron prior to the stem cell infusion.
II. To determine the number of patients who experience nausea and vomiting.
OUTLINE: Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Being tested
- ondansetron, survey administration, management of therapy complications
- Medical subject headings
- Leukemia, Myeloid, Accelerated Phase, Congenital Abnormalities, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis, Pdgfra-Associated Chronic Eosinophilic Leukemia, Leukemia, Myelomonocytic, Chronic, Leukemia, Neutrophilic, Chronic, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetronDrug
Also called GR 38032F, GR-C507/75, Zofran
Given IV
survey administrationOther
Correlative studies
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Ondansetron IV
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron therapy | Experimental | Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation. Receives: Drug: ondansetron; Other: survey administration; Procedure: management of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.
Measured: Baseline up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study start8 Aug 2008
- Primary completion9 Jun 2009
- Study completion10 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Accelerated Phase Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leona Holmberg, Fred Hutchinson Cancer Center
- Investigators
- Leona Holmberg, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795769
- Sponsor's protocol ID
- 2247.00
- Other IDs
- NCI-2010-00325
- Status last verified
- Apr 2017
- First submitted
- 20 Nov 2008
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells
- ClinicalTrials.gov ID
- NCT00795769
- Acronym / sponsor ID
- 2247.00
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 8 Aug 2008 (actual)
- Primary completion
- 9 Jun 2009 (actual)
- Study completion
- 10 Jun 2009 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Posted 23 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant.
PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant.
Detailed description
OBJECTIVES:
- To determine whether the incidence of nausea and vomiting related to administration of autologous hematopoetic stem cells cryopreserved in DMSO can be reduced by the use of a single dose of intravenous ondansetron prior to the stem cell infusion.
II. To determine the number of patients who experience nausea and vomiting.
OUTLINE: Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ondansetron therapy | Experimental | Drug: ondansetron, Other: survey administration, Procedure: management of therapy complicationsPatients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Autologous PBSC transplant patient
- English-speaking
- Planned cryopreserved PBSC infusion at the SCCA outpatient clinic
Key exclusion criteria (5 listed)
- History of prior autologous transplant
- Non-English-speaking
- Planned cryopreserved PBSC infusion at the UWMC inpatient unit
- Infusion of cryopreserved PBSC that are thawed and washed to remove DMSO prior to infusion
- Allergy or adverse reaction to ondansetron
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ondansetronAlso: GR 38032F, GR-C507/75, ZofranGiven IV | Drug | Ondansetron therapy |
| survey administrationCorrelative studies | Other | Ondansetron therapy |
| management of therapy complicationsAlso: complications of therapy, management ofOndansetron IV | Procedure or surgery | Ondansetron therapy |
Primary outcome
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
Time frame: Baseline up to 120 minutes
Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leona Holmberg principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ondansetron, survey administration and management of therapy complications in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Lymphoblastic Leukemia in Remission, run by Fred Hutchinson Cancer Center 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 3 inclusion and 5 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 23 May 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 May 2017). 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?
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates) (time frame: Baseline up to 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2017.