LeukemiaNCT02305979
Evaluation of Loratadine for G-CSF Induced Bone Pain in Patients With Hematologic Malignancies
An observational study of Leukemia and Lymphoma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this project is to assess the efficacy of loratadine in decreasing the incidence and severity of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Loratadine
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Wake Forest Baptist Health Hematology and Oncology Clinic
Who may be able to join
- Receiving a G-CSF after the institution practice change
- Receiving a G-CSF for one of the following indications:
- Prevention/treatment of neutropenia along with treatment for leukemia or lymphoma
- Mobilization of hematopoietic progenitor cells
- Neutropenia prevention following autologous hematopoietic cell transplant
- Took loratadine per protocol with G-CSF administration
- Completed a survey
Who cannot join
- Taking daily antihistamines for allergies, asthma, or other indications, not including bone pain
- Taking daily NSAIDs, with the exception of aspirin, for chronic conditions
- Treatment for solid tumor cancers
- Receiving bone modifying agents for bone pain associated with metastatic disease or other chronic conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Evaluation of Loratadine for Granulocyte-Colony Stimulating Factor Induced Bone Pain in Patients With Hematologic Malignancies
The purpose of this project is to assess the efficacy of loratadine in decreasing the incidence and severity of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. This is a different patient population than those being assessed in current clinical trials.
Read the detailed description
Objectives
The primary objective is to determine the incidence of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. Incidence will be determined via patient-reported incidence following G-CSF administration.
Secondary objectives include determining the efficacy of loratadine for bone pain prevention as indicated by a decrease in incidence and a decrease in severity (questions 4 and 5 of the survey).
- Being tested
- Loratadine
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoratadineDrug
Also called Claritin
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Loratadine | Treatment with Loratadine Receives: Drug: Loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bone pain following G-CSF administration
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LeAnne Kennedy, PharmD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305979
- Sponsor's protocol ID
- IRB00030701
- Other IDs
- CCCWFU 98414
- Status last verified
- Jul 2018
- First submitted
- 1 Dec 2014
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Loratadine for Granulocyte-Colony Stimulating Factor Induced Bone Pain in Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02305979
- Acronym / sponsor ID
- IRB00030701
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to assess the efficacy of loratadine in decreasing the incidence and severity of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. This is a different patient population than those being assessed in current clinical trials.
Detailed description
Objectives
The primary objective is to determine the incidence of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. Incidence will be determined via patient-reported incidence following G-CSF administration.
Secondary objectives include determining the efficacy of loratadine for bone pain prevention as indicated by a decrease in incidence and a decrease in severity (questions 4 and 5 of the survey).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Loratadine | – | Drug: LoratadineTreatment with Loratadine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Wake Forest Baptist Health Hematology and Oncology Clinic
Key inclusion criteria (7 listed)
- Receiving a G-CSF after the institution practice change
- Receiving a G-CSF for one of the following indications:
- Prevention/treatment of neutropenia along with treatment for leukemia or lymphoma
- Mobilization of hematopoietic progenitor cells
- Neutropenia prevention following autologous hematopoietic cell transplant
Key exclusion criteria (4 listed)
- Taking daily antihistamines for allergies, asthma, or other indications, not including bone pain
- Taking daily NSAIDs, with the exception of aspirin, for chronic conditions
- Treatment for solid tumor cancers
- Receiving bone modifying agents for bone pain associated with metastatic disease or other chronic conditions
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 |
|---|---|---|
| LoratadineAlso: Claritin | Drug | Treatment with Loratadine |
Primary outcome
Incidence of bone pain following G-CSF administration
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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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.
LeAnne Kennedy, PharmD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Lymphoma, run by Wake Forest University Health Sciences 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 7 inclusion and 4 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 3 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of bone pain following G-CSF administration (time frame: Day 1). 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 3 Jul 2018.