Trial Search Results

Trial of Acebilustat for the Treatment of Upper Arm Lymphedema

This study is designed to investigate the response of unilateral upper extremity (arm) lymphedema, during pharmacologic treatment of lymphedema with oral placebo and oral acebilustat. Participants will receive "study drug" (Acebilustat or placebo), for 9 months. For 3 of these months, the participant will receive placebo; for 6 of these months, the participant will receive active ingredient, acebilustat. The study is blinded which means that the participant will not be told which study pill they are taking.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Celltaxis LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: Acebilustat
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Upper arm lymphedema, single arm, stage 2, greater than 6 months duration

   - Male or female.

   - Ages 18-75.

   - If a potential participant has undergone surgical treatment, lymph node transfer,
   suction-assisted lipectomy, or lymphatico-venous anastamosis, at least one year must
   have elapsed prior to screening.

   - Consistent use of an appropriately sized compression garment for daytime use.

   - Willing to maintain a stable regimen of self-care from screening to end-of-study.

   - Lymphedema therapy must be completed at least 8 weeks prior to screening.

   - Has received Covid-19 vaccine (Pfizer, Moderna or Johnson & Johnson)

   - Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

   - Concurrent participation in a clinical trial of any other investigational drug or
   therapy

   - Other medical condition that could lead to acute limb edema (e.g. acute blood clot) or
   other medical condition that could result in symptoms overlapping those of lymphedema
   (e.g. frozen shoulder).

   - History of clotting disorder.

   - Chronic (persistent) infection in the affected limb.

   - Active cancer treatment or history of cancer treatment within the past 2 years, except
   for non-melanoma skin cancer or cervical cancer in-situ.

   - Chronic kidney disease

   - Liver disease

   - Pregnancy or nursing.

   - Substance abuse (e.g., alcohol or drug abuse) within 6 months prior to screening.

   - Any current use of non-steroidal anti-inflammatory drug (NSAID), e.g. ibuprofen,
   ketoprofen) or prior therapeutic use of ketoprofen.

   - Any current use of immunosuppressive or immunomodulatory drugs (e.g.,
   immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or
   interleukin receptor blockers) or leukotriene pathway inhibitor (zileuton),
   leukotriene receptor antagonist (e.g montelukast).

   - Personal or family history of prolonged QT syndrome

   - Any reason (in addition to those listed above) that, in the opinion of the
   investigator, precludes full participation in the study.

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Leslie Jacome-Roche, RN
650-723-1396
Recruiting