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

NCT ID: NCT01830010

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-28

Study Completion Date

2018-08-21

Brief Summary

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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

Detailed Description

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Conditions

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Hematological Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study Part 1: KRP203

All patients to receive KRP203 for 111days

Group Type EXPERIMENTAL

Study Part 1: KRP203

Intervention Type DRUG

All subjects will receive KRP203 for 111 days

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

Group Type EXPERIMENTAL

Study Part 2: KRP203 lower dose

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Study Part 2: KRP203 higher dose

Intervention Type DRUG

Interventions

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Study Part 1: KRP203

All subjects will receive KRP203 for 111 days

Intervention Type DRUG

Study Part 2: KRP203 lower dose

Intervention Type DRUG

Study Part 2: KRP203 higher dose

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Regensburg, Bavaria, Germany

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Jena, , Germany

Site Status

Novartis Investigative Site

Basel, , Switzerland

Site Status

Novartis Investigative Site

Zurich, , Switzerland

Site Status

Countries

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France Germany Switzerland

References

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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.

Reference Type DERIVED
PMID: 36343893 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17443

Results for CKRP203A2105 can be found on the Novartis Clinical Trial Results Website

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=296

A Plain Language Trial Summary is available on novartisclinicatrials.com

Other Identifiers

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CKRP203A2105

Identifier Type: -

Identifier Source: org_study_id