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A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Myelofibrosis

Intervention: Ruxolitinib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after treatment interruption due to loss of response and/or adverse events.

Clinical Details

Official title: The ReTreatment Trial: A Phase II, Open-label, Single-arm Study of Re-treating Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The effect of re-treatment with ruxolitinib on reduction in spleen volume of at least 20% from baseline, by Week 24

Secondary outcome:

The effect of re-treatment with ruxolitinib on reduction in spleen volume of at least 35% from baseline, by Week 24

The effect of re-treatment with ruxolitinib on reduction in spleen length of at least 25% and 50% respectively, from baseline, by Week 24

The effect of re-treatment with ruxolitinib on reduction in spleen volume and length over time

The safety after re-treatment with ruxolitinib

The effect of re-treatment with ruxolitinib on reduction in MPN-SAF TSS of at least 25% and 50% respectively, from baseline, by Week 24

The effect of re-treatment with ruxolitinib on reduction in MPN-SAF TSS over time

The effect of re-treatment with ruxolitinib on Patient Global Impression of Change (PGIC)

The effect of re-treatment with ruxolitinib on EORTC QLQ-C30 and EQ-5D-5L

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Confirmed diagnosis of PMF, PPV MF or PET-MF, irrespective of JAK2 mutational status

according to the 2008 revised International Standard Criteria

- Peripheral blast count < 10%

- Requires therapy for MF in the opinion of the investigator

- Received prior monotherapy treatment with ruxolitinib for at least 12 consecutive

weeks and experienced treatment interruption because of lossof response or adverse event

- Patients adhering to the Screening phase assessments and undergoing a a

ruxolitinib-free washout period of a minimum of 1 week and a maximum of 8 weeks

- ECOG performance status 0, 1, 2, or 3

- Adequate bone marrow function

- Written informed consent

Exclusion Criteria:

- Patients not initially responding (primary resistance) to ruxolitinib therapy

- Patients who underwent a splenectomy or spleen radiation

- Patients currently scheduled for bone marrow transplant

- Patients who have discontinued ruxolitinib < 14 days prior to screening

- Patients who are not able to receive a starting dose of ruxolitinib of at least 15 mg

total daily dose

- Leukemic transformation

- Inadequate renal function

- Presence of clinically meaningful active bacterial, fungal, parasitic or viral

infection which requires therapy

- Previous history of Progressive Multifocal Leuko-encephalopathy (PML)

- Clinically significant cardiac disease or significant concurrent medical condition

Locations and Contacts

Novartis Investigative Site, Leipzig 04103, Germany

Novartis Investigative Site, Madrid 28034, Spain

Novartis Investigative Site, Salamanca, Castilla y Leon 37007, Spain

Novartis Investigative Site, Firenze, FI 50134, Italy

Additional Information

Starting date: September 2014
Last updated: March 31, 2015

Page last updated: August 23, 2015

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