Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma

April 22, 2019 updated by: M.D. Anderson Cancer Center

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Age >= 18 years old.
  4. ECOG performance status 0-3.
  5. Ability to provide informed consent for participation.

Exclusion Criteria:

  1. Existing chronic bone pain prior to pegfilgrastim usage.
  2. Creatinine clearance of <50ml/minute by Cockcroft Gault equation.
  3. Allergy to filgrastim, pegfilgrastim, or Loratadine.
  4. Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication.
  5. Inability to swallow medications.
  6. Inability to complete the survey instrumentation accurately.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 - Loratadine

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.
Drug: Pegfilgrastim
6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.
Other Names:
  • Neulasta
  • PEG-G-CSF
Drug: Loratadine

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.

Other: Placebo

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.

Other Names:
  • Sugar Pill
Behavioral: Questionnaires
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.
Other Names:
  • Surveys
Experimental: Group 2 - Placebo

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.
Drug: Pegfilgrastim
6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.
Other Names:
  • Neulasta
  • PEG-G-CSF
Drug: Loratadine

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.

Other: Placebo

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.

Other Names:
  • Sugar Pill
Behavioral: Questionnaires
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.
Other Names:
  • Surveys

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason R. Westin, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-0880
  • NCI-2015-00592 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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