TerminatedEarly Phase 1

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

Stopped: Slow Accrual

United States1 participantsStarted 2015-12-14

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Bone Pain Related Quality of Life (QOL) Measured by FACT-Bone Pain (FACT-BP) Questionnaire

Timeframe: 26 weeks

Trial details

NCT IDNCT02392039

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-04

View on ClinicalTrials.gov More Lymphoma trials