Study Stopped
Slow Accrual
Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma
Randomized, Placebo Controlled Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma
2 other identifiers
interventional
1
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1 lymphoma
Started Dec 2015
Shorter than P25 for early_phase_1 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedStudy Start
First participant enrolled
December 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2018
CompletedApril 23, 2019
April 1, 2019
2.3 years
March 12, 2015
April 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
26 weeks
Study Arms (2)
Group 1 - Loratadine
EXPERIMENTALPegfilgrastim 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
EXPERIMENTALPegfilgrastim 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.
Interventions
6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Amgencollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason R. Westin, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 18, 2015
Study Start
December 14, 2015
Primary Completion
April 4, 2018
Study Completion
April 4, 2018
Last Updated
April 23, 2019
Record last verified: 2019-04