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

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Lymphoma

In brief

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).

Key facts

Study ID

NCT02392039

Run by

M.D. Anderson Cancer Center

People needed

1

Starts

2015-12-14

Expected to finish

2018-04-04

Last updated by the study team

2019-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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