NCT01830010

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_1

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

June 28, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2018

Completed
Last Updated

December 11, 2020

Status Verified

November 1, 2018

Enrollment Period

5.2 years

First QC Date

April 9, 2013

Last Update Submit

December 9, 2020

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

  • 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

    111 days

Secondary Outcomes (5)

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

    111 days

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

    111 days

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

    111 days

  • GVHD-free, relapse free survival

    1 years post-transplant

  • GVHD-free, relapse free survival

    2 years post transplant

Study Arms (3)

Study Part 1: KRP203

EXPERIMENTAL

All patients to receive KRP203 for 111days

Drug: Study Part 1: KRP203

Study Part 2: lower KRP203 dose

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

Drug: Study Part 2: KRP203 lower dose

Study Part 2: higher KRP203 dose

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

Drug: Study Part 2: KRP203 higher dose

Interventions

Study Part 1: KRP203DRUG

All subjects will receive KRP203 for 111 days

Study Part 1: KRP203
Study Part 2: KRP203 lower doseDRUG
Study Part 2: lower KRP203 dose
Study Part 2: KRP203 higher doseDRUG
Study Part 2: higher KRP203 dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative Site

Paris, 75010, France

Location

Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

Location

Novartis Investigative Site

Cologne, 50937, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Basel, 4031, Switzerland

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Dertschnig S, Gergely P, Finke J, Schanz U, Holler E, Holtick U, Socie G, Medinger M, Passweg J, Teshima T, Stylianou C, Oehen S, Heim D, Bucher C. Mocravimod, a Selective Sphingosine-1-Phosphate Receptor Modulator, in Allogeneic Hematopoietic Stem Cell Transplantation for Malignancy. Transplant Cell Ther. 2023 Jan;29(1):41.e1-41.e9. doi: 10.1016/j.jtct.2022.10.029. Epub 2022 Nov 4.

    PMID: 36343893DERIVED

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

June 28, 2013

Primary Completion

August 21, 2018

Study Completion

August 21, 2018

Last Updated

December 11, 2020

Record last verified: 2018-11

Locations

CH(2)DE(5)FR(1)