Clinical trial · Interventional
A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies
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
NCT01830010CI-TRIAL-00048813completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Study Part 1: KRP203 | Drug | — | UNRESOLVED |
| Study Part 2: KRP203 higher dose | Drug | — | UNRESOLVED |
| Study Part 2: KRP203 lower dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Study Part 1: KRP203
- description
- All patients to receive KRP203 for 111days
- interventionNames
- Drug: Study Part 1: KRP203
- type
- EXPERIMENTAL
- label
- Study Part 2: lower KRP203 dose
- description
- 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
- interventionNames
- Drug: Study Part 2: KRP203 lower dose
- type
- EXPERIMENTAL
- label
- Study Part 2: higher KRP203 dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDDertschnig 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 36343893