Status:
COMPLETED
A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in Part 2 only) of KRP203 in patients undergoing allogeneic hemopoietic stem cell transplant for hematological mali...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01830010
Start Date
June 28 2013
End Date
August 21 2018
Last Update
December 11 2020
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Paris, France, 75010
2
Novartis Investigative Site
Regensburg, Bavaria, Germany, 93053
3
Novartis Investigative Site
Cologne, Germany, 50937
4
Novartis Investigative Site
Freiburg im Breisgau, Germany, 79106