BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron

Conditions

• Nausea With Vomiting Chemotherapy-Induced

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Granisetron Transdermal Patch — DRUG
  Antiemetic
• Intravenous Dexamethasone — DRUG
  Antiemetic
• Ondansetron — DRUG
  ondansetron

Study Details

Patients undergoing either an autologous or allogeneic hematopoietic stem cell transplant (HSCT) and receiving preparative chemotherapy experience a considerable amount of chemotherapy-induced nausea and vomiting (CINV). Current strategies at reducing CINV in this patient population are suboptimal due to lack of efficacy and supportive evidence, potential for increased adverse events, and drug-drug and drug-disease contraindications.

Key Dates

Start date

May 14, 2020

Status verified

Nov 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Arm 1
  ARM 1 -transdermal granisetron plus intravenous dexamethasone
• Active Comparator: ARM 2
  ARM 2 -intravenous ondansetron plus intravenous dexamethasone

Primary Outcome Measure

To compare between the two study arms the number of patients achieving complete response (no vomiting and no use of rescue medications) during the acute period (0-24 hours post-chemotherapy) for patients receiving preparative chemotherapy and HSCT. [ Time Frame: 0 hours to 24 hours post-chemotherapy ]

Central Contacts

• Karen Sweiss, PharmD
  312-996-0875
  [email protected]

Locations (1)

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