LymphomaEarly Phase 1NCT02392039
Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma
A Early Phase 1 study testing Pegfilgrastim, Loratadine and Questionnaires in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if loratadine can control bone pain caused by pegfilgrastim (a drug given after chemotherapy to help raise white blood cell counts). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Pegfilgrastim, Loratadine and Questionnaires
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2015to 4 Apr 2018
- Phase
- Early Phase 1
- 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
Who may be able to join
- Patients must have newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Grade 3B Follicular lymphoma, Burkitt Lymphoma, Peripheral T cell Lymphoma NOS, NK/T cell Lymphoma, or Transformed lymphoma.
- Planned to receive chemotherapy for 6 cycles which the treating physician plans to utilize for pegfilgrastim to minimize risk for neutropenic fever, including but not limited to R-CHOP, R-EPOCH, and R-HyperCVAD, CHOP, and SMILE.
- Age >= 18 years old.
- ECOG performance status 0-3.
- Ability to provide informed consent for participation.
Who cannot join
- Existing chronic bone pain prior to pegfilgrastim usage.
- Creatinine clearance of <50ml/minute by Cockcroft Gault equation.
- Allergy to filgrastim, pegfilgrastim, or Loratadine.
- Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication.
- Inability to swallow medications.
- Inability to complete the survey instrumentation accurately.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Randomized, Placebo Controlled Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma
The goal of this clinical research study is to learn if loratadine can control bone pain caused by pegfilgrastim (a drug given after chemotherapy to help raise white blood cell counts).
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group.
- If you are in Group 1, during Cycles 1 and 3 you will receive loratadine. During Cycles 2 and 4, you will receive a placebo.
- If you are in Group 2, during Cycles 1 and 3 you will receive a placebo. During Cycles 2 and 4, you will receive a loratadine.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Both groups will receive pegfilgrastim after standard of care chemotherapy.
Neither you nor the study staff will know when you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug Administration:
Each study cycle is 21 days.
On Day 1 of Cycles 1-6, you will receive pegfilgrastim through a needle under the skin.
On Days 1-7 of Cycles 1-4, you will take loratadine/placebo by mouth 1 time every day.
If you have any bone pain during Cycles 1-4, you will take loratadine on Days 1-7 of Cycles 5 and 6. If you do not have bone pain, you will be off study after Cycle 4.
The study doctor will decide if you need any extra pain medication.
You will be given a diary to write down when you take loratadine/placebo, and to write down the amount and time of any pain medications they need, and to describe the location, severity, and description of the pain you experience.
Study Visits:
During Cycles 1-4 (and if you have pain, during Cycles 6-7), before you receive pegfilgrastim and on Day 7, you will complete 3 questionnaires about your bone pain and how you are feeling. The should take about 20 minutes to complete. If you are not coming into the clinic, you will be asked to mail in the questionnaires and your diary.
Before each cycle starts, blood (about 2-4 teaspoons) will be drawn for routine tests and to test your liver, bone, and kidneys.
On Day 1 of Cycles 2-6, you will have a physical exam, and blood (about 3-4 teaspoons) will be drawn for routine tests.
On Days 7 and 14 of each cycle (+/- 3 days), blood (about 2-4 teaspoons) will be drawn for routine tests.
Length of Study:
You may continue taking the study drugs for up to 18 weeks (6 cycles). You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation in this study will be over after the end-of-study visit.
End-of-Study Visit:
Within 8 weeks after your last dose of study drugs:
- You will have a physical exam.
- You will complete the 3 questionnaires about your bone pain and how you are feeling.
- Blood (about 2-4 teaspoons) will be drawn for routine tests and to test your liver, bone, and kidneys.
This is an investigational study. Loratadine is FDA approved and commercially available for the treatment of seasonal allergies. Pegfilgrastim is FDA approved and commercially available for improvement of chemotherapy-related neutropenia. The use of loratadine to control bone pain is investigational.
Up to 56 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Lymphoma
- Being tested
- Pegfilgrastim, Loratadine, Placebo, Questionnaires
- Keywords
- Lymphoma, Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Grade 3B Follicular Lymphoma, Burkitt Lymphoma, Peripheral T cell Lymphoma NOS, NK/T cell Lymphoma, Transformed Lymphoma, Aggressive lymphoma, Bone pain, Pegfilgrastim, Neulasta, PEG-G-CSF, Loratadine, Placebo, Sugar pill, Questionnaires, Surveys
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Burkitt Lymphoma, Lymphoma, T-Cell, Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegfilgrastimDrug
Also called Neulasta, PEG-G-CSF
6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.
LoratadineDrug
Group 1 - Cycles 1 and 3: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
Group 2 - Cycle 2 and 4: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
PlaceboOther
Also called Sugar Pill
Group 1 - Cycle 2 and 4: Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
Group 2 - Cycle 1 and 3 : Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
QuestionnairesBehavioural
Also called Surveys
Three questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Loratadine | Experimental | Pegfilgrastim 6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.
Cycle 1 and 3:
Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
Cycle 2 and 4:
Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
Three questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs. Receives: Drug: Pegfilgrastim; Drug: Loratadine; Other: Placebo; Behavioral: Questionnaires |
| Group 2 - Placebo | Experimental | Pegfilgrastim 6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.
Cycle 1 and 3:
Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
Cycle 2 and 4:
Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
Three questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs. Receives: Drug: Pegfilgrastim; Drug: Loratadine; Other: Placebo; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Pain Related Quality of Life (QOL) Measured by FACT-Bone Pain (FACT-BP) Questionnaire
FACT-BP (range: 0 - 60) questionnaire used to measure patients bone pain. Participant considered having bone pain if the answer for question BP1 in the FACT-BP questionnaire is >0.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start14 Dec 2015
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Jason R. Westin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392039
- Sponsor's protocol ID
- 2014-0880
- Other IDs
- NCI-2015-00592
- Status last verified
- Apr 2019
- First submitted
- 12 Mar 2015
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo Controlled Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma
- ClinicalTrials.gov ID
- NCT02392039
- Acronym / sponsor ID
- 2014-0880
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Grade 3B Follicular Lymphoma, Burkitt Lymphoma, Peripheral T cell Lymphoma NOS, NK/T cell Lymphoma, Transformed Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 18 Mar 2015 (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 goal of this clinical research study is to learn if loratadine can control bone pain caused by pegfilgrastim (a drug given after chemotherapy to help raise white blood cell counts).
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group.
- If you are in Group 1, during Cycles 1 and 3 you will receive loratadine. During Cycles 2 and 4, you will receive a placebo.
- If you are in Group 2, during Cycles 1 and 3 you will receive a placebo. During Cycles 2 and 4, you will receive a loratadine.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Both groups will receive pegfilgrastim after standard of care chemotherapy.
Neither you nor the study staff will know when you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug Administration:
Each study cycle is 21 days.
On Day 1 of Cycles 1-6, you will receive pegfilgrastim through a needle under the skin.
On Days 1-7 of Cycles 1-4, you will take loratadine/placebo by mouth 1 time every day.
If you have any bone pain during Cycles 1-4, you will take loratadine on Days 1-7 of Cycles 5 and 6. If you do not have bone pain, you will be off study after Cycle 4.
The study doctor will decide if you need any extra pain medication.
You will be given a diary to write down when you take loratadine/placebo, and to write down the amount and time of any pain medications they need, and to describe the location, severity, and description of the pain you experience.
Study Visits:
During Cycles 1-4 (and if you have pain, during Cycles 6-7), before you receive pegfilgrastim and on Day 7, you will complete 3 questionnaires about your bone pain and how you are feeling. The should take about 20 minutes to complete. If you are not coming into the clinic, you will be asked to mail in the questionnaires and your diary.
Before each cycle starts, blood (about 2-4 teaspoons) will be drawn for routine tests and to test your liver, bone, and kidneys.
On Day 1 of Cycles 2-6, you will have a physical exam, and blood (about 3-4 teaspoons) will be drawn for routine tests.
On Days 7 and 14 of each cycle (+/- 3 days), blood (about 2-4 teaspoons) will be drawn for routine tests.
Length of Study:
You may continue taking the study drugs for up to 18 weeks (6 cycles). You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation in this study will be over after the end-of-study visit.
End-of-Study Visit:
Within 8 weeks after your last dose of study drugs:
- You will have a physical exam.
- You will complete the 3 questionnaires about your bone pain and how you are feeling.
- Blood (about 2-4 teaspoons) will be drawn for routine tests and to test your liver, bone, and kidneys.
This is an investigational study. Loratadine is FDA approved and commercially available for the treatment of seasonal allergies. Pegfilgrastim is FDA approved and commercially available for improvement of chemotherapy-related neutropenia. The use of loratadine to control bone pain is investigational.
Up to 56 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Loratadine | Experimental | Drug: Pegfilgrastim, Drug: Loratadine, Other: Placebo, Behavioral: QuestionnairesPegfilgrastim 6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle. Cycle 1 and 3: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days. Cycle 2 and 4: Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days. Three questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs. |
| Group 2 - Placebo | Experimental | Drug: Pegfilgrastim, Drug: Loratadine, Other: Placebo, Behavioral: QuestionnairesPegfilgrastim 6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle. Cycle 1 and 3: Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days. Cycle 2 and 4: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days. Three questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Grade 3B Follicular lymphoma, Burkitt Lymphoma, Peripheral T cell Lymphoma NOS, NK/T cell Lymphoma, or Transformed lymphoma.
- Planned to receive chemotherapy for 6 cycles which the treating physician plans to utilize for pegfilgrastim to minimize risk for neutropenic fever, including but not limited to R-CHOP, R-EPOCH, and R-HyperCVAD, CHOP, and SMILE.
- Age >= 18 years old.
- ECOG performance status 0-3.
- Ability to provide informed consent for participation.
Key exclusion criteria (6 listed)
- Existing chronic bone pain prior to pegfilgrastim usage.
- Creatinine clearance of <50ml/minute by Cockcroft Gault equation.
- Allergy to filgrastim, pegfilgrastim, or Loratadine.
- Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication.
- Inability to swallow medications.
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 |
|---|---|---|
| PegfilgrastimAlso: Neulasta, PEG-G-CSF6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle. | Drug | Group 1 - Loratadine, Group 2 - Placebo |
| LoratadineGroup 1 - Cycles 1 and 3: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days. Group 2 - Cycle 2 and 4: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days. | Drug | Group 1 - Loratadine, Group 2 - Placebo |
| PlaceboAlso: Sugar PillGroup 1 - Cycle 2 and 4: Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days. Group 2 - Cycle 1 and 3 : Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days. | Other | Group 1 - Loratadine, Group 2 - Placebo |
| QuestionnairesAlso: SurveysThree questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs. | Behavioural | Group 1 - Loratadine, Group 2 - Placebo |
Primary outcome
Bone Pain Related Quality of Life (QOL) Measured by FACT-Bone Pain (FACT-BP) Questionnaire
Time frame: 26 weeks
FACT-BP (range: 0 - 60) questionnaire used to measure patients bone pain. Participant considered having bone pain if the answer for question BP1 in the FACT-BP questionnaire is >0.
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Jason R. Westin, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pegfilgrastim, Loratadine and Questionnaires in people with Lymphoma, run by M.D. Anderson 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 5 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: stopped early, as of the sponsor's last update on 23 Apr 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
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?
Bone Pain Related Quality of Life (QOL) Measured by FACT-Bone Pain (FACT-BP) Questionnaire (time frame: 26 weeks). 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 Apr 2019.