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A Single-arm, Open-label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KRP203 in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant for Hematological Malignancies


Phase 1
18 Years
65 Years
Not Enrolling
Both
Hematological Malignancies

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Trial Information

A Single-arm, Open-label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KRP203 in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant for Hematological Malignancies

Inclusion Criteria


Inclusion Criteria

- Patients aged 18 to 65 years, inclusive

- Patients must have a hematological malignancy that as per standard medical practice
requires myeloablative conditioning (including short term myeloablative reduced
intensity conditioning) followed by allogeneic hematopoetic stem cell transplant

- Karnofsky Performance status ≥60%.

- Suitable stem cell source available according to the graft selection algorithm
using T-cell replete peripheral stem cells as a graft source

Exclusion Criteria:

- Resting heart rate below 55

- Significant cardiac disease (such as arrhytmia, heart failure) or any significant
condition which in the investigators opinion would make the patient ineligible

- Previous allogeneic HSCT

- Any drug required that is not compatible with KRP203 (e.g. beta-blockers or
anti-thymocyte globulin)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Number of participants with Adverse Events as a Measure of safety

Outcome Description:

Safety and tolerability of KRP203 in patients undergoing allogeneic hematopoetic stem cell transplant for hematological malignancies

Outcome Time Frame:

111 days

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Switzerland: Swissmedic

Study ID:

CKRP203A2105

NCT ID:

NCT01830010

Start Date:

April 2013

Completion Date:

May 2015

Related Keywords:

  • Hematological Malignancies
  • Neoplasms
  • Hematologic Neoplasms

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