- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01830010
A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies
A Two-part, Single- and Two Arm Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy (in Part 2 Only) of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75010
- Novartis Investigative Site
-
-
-
-
-
Freiburg, Germany, 79106
- Novartis Investigative Site
-
Hamburg, Germany, 20246
- Novartis Investigative Site
-
Jena, Germany, 07740
- Novartis Investigative Site
-
Koeln, Germany, 50937
- Novartis Investigative Site
-
-
Bavaria
-
Regensburg, Bavaria, Germany, 93053
- Novartis Investigative Site
-
-
-
-
-
Basel, Switzerland, 4031
- Novartis Investigative Site
-
Zürich, Switzerland, 8091
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Part 1: KRP203
All patients to receive KRP203 for 111days
|
All subjects will receive KRP203 for 111 days
|
Experimental: Study Part 2: lower KRP203 dose
in this treatment arm patients will receive the lower KRP203 dose for 111 days on top of the standard treatment with cyclosporine A and methotrexte for GVHD prophylaxis
|
|
Experimental: Study Part 2: higher KRP203 dose
in this treatment arm patients will recieve the higher KRP203 dose for 111 days on top of standard treatment with tacrolimus and methotrexate for GVHD prophylaxis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Adverse Events as a Measure of safety
Time Frame: 111 days
|
Safety and tolerability of KRP203 in patients undergoing allogeneic hematopoetic stem cell transplant for hematological malignancies
|
111 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Pharmacokinetics of KRP203: Area under the Plasma Concentration-time Curve (AUC)
Time Frame: 111 days
|
The main PK parameters will be determined in whole blood using non-compartmental methods.
Pk parameters being measured are: AUCtau AUC during a dosing interval (tau) of 24 hours [h.ng/mL] , AUCtauR Molar ratios between KRP203-P and KRP203 based on Cmax or AUCtau
|
111 days
|
Plasma Pharmacokinetics (PK) of KRP203: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)
Time Frame: 111 days
|
Cmax Maximum (peak) blood drug concentration after drug administration [ng/mL]
|
111 days
|
Plasma Pharmacokinetics (PK) of KRP203: Time to reach the maximum concentration after drug administration
Time Frame: 111 days
|
Tmax Time to reach maximum (peak) concentration [ng/mL]
|
111 days
|
GVHD-free, relapse free survival
Time Frame: 1 years post-transplant
|
occurence of GVHD, disease relaps and death will be assessed
|
1 years post-transplant
|
GVHD-free, relapse free survival
Time Frame: 2 years post transplant
|
occurence of GVHD, disease relaps and death will be assessed
|
2 years post transplant
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CKRP203A2105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hematological Malignancies
-
Tel-Aviv Sourasky Medical CenterMeir Medical Center; Max Planck Institute for Infection BiologyUnknownPediatric Solid Malignancies | Pediatric Hematological MalignanciesIsrael
-
AdaptimmuneTerminatedSolid and Hematological MalignanciesUnited States, Canada
-
Senti BiosciencesNot yet recruitingAML/MDS | CD33 Expressing Hematological Malignancies | FLT3 Expressing Hematological Malignancies
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingRelapsed/Refractory Hematological MalignanciesChina
-
AdaptimmuneRecruitingSolid and Hematological MalignanciesUnited States, Spain, Canada, United Kingdom
-
Kite, A Gilead CompanyEnrolling by invitationSolid and Hematological MalignanciesUnited States, Netherlands, Japan, Australia, France, Israel, Germany, Canada, United Kingdom
-
AstraZenecaParexelCompletedSolid and Hematological MalignanciesGermany
-
Baylor College of MedicineCenter for Cell and Gene Therapy, Baylor College of MedicineCompletedMyeloid Hematological MalignanciesUnited States
-
Centre Hospitalier Universitaire de BesanconTerminatedHematological Malignancies BFrance
-
CASI Pharmaceuticals, Inc.CompletedRelapsed or Refractory Hematological MalignanciesCanada
Clinical Trials on Study Part 1: KRP203
-
Bilthoven BiologicalsSerum Institute of India Pvt. Ltd.CompletedImmune Response to Oral Polio VaccineBangladesh
-
U.S. Army Medical Research and Development CommandNational Institutes of Health (NIH); Mahidol UniversityCompletedDiarrhea | Dysentery | ShigellaThailand
-
Société des Produits Nestlé (SPN)CompletedExocrine Pancreatic InsufficiencyAustralia, New Zealand
-
Novartis PharmaceuticalsCompletedPrimary Biliary CholangitisUnited States, Germany, Russian Federation, Canada, United Kingdom, Poland
-
PfizerCompletedRheumatoid Arthritis | Healthy VolunteersUnited States
-
Ichnos Sciences SAGlenmark Pharmaceuticals S.A.CompletedModerate to Severe Atopic DermatitisUnited States, Canada, Czechia, Germany, Poland
-
Chiesi Farmaceutici S.p.A.CompletedCystic Fibrosis | Non-Cystic Fibrosis BronchiectasisBelgium
-
Janssen Research & Development, LLCCompletedHealthy | Asthma | Atopic DermatitisGermany, Belgium
-
Janssen Research & Development, LLCPharmacyclics LLC.CompletedCD20-positive B-cell Non-Hodgkin LymphomaUnited States, France
-
Akesobio Australia Pty LtdCompletedAtopic DermatitisNew Zealand, Australia