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

Novartis Pharmaceuticals23 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hematological Malignancies

Interventions

Study Part 1: KRP203DRUG

All subjects will receive KRP203 for 111 days

Study Part 2: KRP203 lower doseDRUG

Study Part 2: KRP203 higher doseDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (8)

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Regensburg, Bavaria, Germany

Novartis Investigative Site

Cologne, Germany

Novartis Investigative Site

Freiburg im Breisgau, Germany

Outcomes

Primary Outcomes

Number of participants with Adverse Events as a Measure of safety

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

Time frame: 111 days

Secondary Outcomes

Plasma Pharmacokinetics of KRP203: Area under the Plasma Concentration-time Curve (AUC)

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

Time frame: 111 days

Plasma Pharmacokinetics (PK) of KRP203: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)

Cmax Maximum (peak) blood drug concentration after drug administration \[ng/mL\]

Time frame: 111 days

Plasma Pharmacokinetics (PK) of KRP203: Time to reach the maximum concentration after drug administration

Tmax Time to reach maximum (peak) concentration \[ng/mL\]

Time frame: 111 days

GVHD-free, relapse free survival

occurence of GVHD, disease relaps and death will be assessed

Time frame: 1 years post-transplant

GVHD-free, relapse free survival

occurence of GVHD, disease relaps and death will be assessed

Time frame: 2 years post transplant

Data from ClinicalTrials.gov

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