Completed

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

What is being tested

Study Part 1: KRP203

+ Study Part 2: KRP203 lower dose

+ Study Part 2: KRP203 higher dose

Drug

Who is being recruted

Hematologic Diseases+2

+ Hemic and Lymphatic Diseases

+ Neoplasms

From 18 to 65 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 1

Interventional

Study Start: June 2013

See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals

Last updated: December 11, 2020

Sourced from a government-validated database.Claim as a partner

Study start date: June 28, 2013

Actual date on which the first participant was enrolled.

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

NCT01830010

Principal SponsorNovartis Pharmaceuticals

Last updated: December 11, 2020

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasmsNeoplasms by SiteHematologic Neoplasms

Criteria

4 inclusion criteria required to participate

Karnofsky Performance status >= 60%

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

Suitable stem cell source available according to the graft selection algorithm using T-cell replete peripheral stem cells as a graft source

4 exclusion criteria prevent from participating

Any drug required that is not compatible with KRP203 (e.g. beta-blockers or anti-thymocyte globulin)

Previous allogeneic HSCT

Resting heart rate below 55

Significant cardiac disease (such as arrhythmia, heart failure) or any significant condition which in the investigator's opinion would make the patient ineligible

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

All patients to receive KRP203 for 111days

Group II

Experimental

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

Group III

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Novartis Investigative Site

Paris, FranceOpen Novartis Investigative Site in Google Maps

Novartis Investigative Site

Regensburg, Germany

Novartis Investigative Site

Cologne, Germany

Novartis Investigative Site

Freiburg im Breisgau, Germany

Completed8 Study Centers