A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies

December 9, 2020 updated by: Novartis Pharmaceuticals

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

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 malignancies

Study Overview

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2013

Primary Completion (Actual)

August 21, 2018

Study Completion (Actual)

August 21, 2018

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CKRP203A2105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

No

Studies a U.S. FDA-regulated device product

No

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.

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