Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

All Drugs and Chemicals

Anti-Infective Agents

Methotrexate

Cyclosporine

Cyclosporins

Tacrolimus

All patients to receive KRP203 for 111days

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

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

All subjects will receive KRP203 for 111 days

Study Part 1: KRP203

Study Part 2: KRP203 lower dose

Study Part 2: KRP203 higher dose

Novartis Pharmaceuticals

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

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

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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

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

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

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

occurence of GVHD, disease relaps and death will be assessed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies	NCT01830010	Hematological M...	Study Part 1: K... Study Part 2: K... Study Part 2: K...	18 Years - 65 Years	Novartis
A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies	NCT01830010	Hematological M...	Study Part 1: K... Study Part 2: K... Study Part 2: K...	18 Years - 65 Years	Novartis

Spots Global Cancer Trial Database for study part 2: krp203 higher dose