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Prospective, Single-arm Phase 2 Trial to Evaluate Efficacy and Safety of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation for Hematologic Malignancies


Phase 2
18 Years
N/A
Not Enrolling
Both
Hematologic Malignancies

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Trial Information

Prospective, Single-arm Phase 2 Trial to Evaluate Efficacy and Safety of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation for Hematologic Malignancies


Inclusion Criteria:



1. Patients undergoing hematopoietic stem cell transplantation conditioned with highly
or moderately emetogenic drugs or total body irradiation (TBI) for hematologic
malignancies

2. aged over 18 yrs

3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

4. patients who are able to take oral medications

5. patients who get well-informed and sign the consent

Exclusion Criteria:

1. Patients complicating

- severe hypertension (systolic blood pressure > 210 mmHg or diastolic blood
pressure > 120 mmHg)

- significant heart disease such as congestive heart failure

- renal insufficiency (serum Cr >= 3.0 mg/dL)

- liver disease (Aspartate aminotransferase (AST), alanine aminotransferase (ALT)
> 3 upper normal limit; alkaline phosphatase (ALP) > 2 upper normal limit)

2. Patients complicated by conditions such as gastrointestinal obstruction or active
peptic ulcer causing emesis

3. Patients with brain tumor, brain metastasis and epilepsy

4. Patients with the history of extrapyramidal symptom

5. Patients with the history of allergy to serotonin antagonists

6. pregnant or lactating women

7. Patients with drug abuse or psychiatric illness, or patients who are not capable of
the normal communications

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

efficacy of ramosetron in terms of complete response (no emesis, no rescue therapy) during the conditioning regimen and within 3 or 6 days after the end of the conditioning regimen

Outcome Time Frame:

within 1 week after the end of conditioning regimen

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

CBMTC-supp001

NCT ID:

NCT01788605

Start Date:

February 2013

Completion Date:

September 2013

Related Keywords:

  • Hematologic Malignancies
  • hematologic malignancies
  • hematopoietic stem cell transplantation
  • ramosetron
  • emesis
  • Neoplasms
  • Hematologic Neoplasms

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