Clinical trial · Interventional
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
NCT02392039CI-TRIAL-00038295terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Loratadine | Drug | — | UNRESOLVED |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
| Placebo | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 - Loratadine
- description
- 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.
- interventionNames
- Drug: Pegfilgrastim
- Drug: Loratadine
- Other: Placebo
- Behavioral: Questionnaires
- type
- EXPERIMENTAL
- label
- Group 2 - Placebo
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.