Skip to main content
OpenTrials
Completed

NCT Number: NCT01830010

A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Study Part 1: KRP203

Drug

All subjects will receive KRP203 for 111 days

Study Part 2: KRP203 lower dose

Drug

Study Part 2: KRP203 higher dose

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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]

  3. 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]

  4. GVHD-free, relapse free survival

    Time frame: 1 years post-transplant

    occurence of GVHD, disease relaps and death will be assessed

  5. GVHD-free, relapse free survival

    Time frame: 2 years post transplant

    occurence of GVHD, disease relaps and death will be assessed

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2013
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.