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Trial record 11 of 24 for:    Prochymal

Efficacy and Safety of Prochymal™ Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00562497
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )

Tracking Information
First Submitted Date  ICMJE November 20, 2007
First Posted Date  ICMJE November 22, 2007
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE September 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2007)
Achieved an induction of a complete response, Followed by 28 days of maintenance of a clinically meaningful response that does not did not require an increase in corticosteroid dose , did not require second line therapy and survived 90 days. [ Time Frame: 90 Days ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2007)
Proportion of patients who have met all of the following conditions; achieved an induction of a complete response, CR, followed by 28 days of maintenance of a clinically meaningful response that does not require an increase in corticosteroid dose greater [ Time Frame: 90 Days ]
Change History Complete list of historical versions of study NCT00562497 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2007)
Overall response, Induction of a two grade decrease in GVHD and Maintenance, Induction of a CR lasting ≥14 days, Time to CR, Incidence of CR per organ, Total steroid dose through Day 90, Incidence of Steroid/Infectious complications [ Time Frame: 90 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2007)
Overall response rate (CR+PR) Induction of a two grade decrease in GVHD, Maintenance of a two grade decrease in GVHD, Induction of a CR lasting ≥14 days, Time to CR, Incidence of CR per organ, Total steroid dose administered through study Day 90, Inc [ Time Frame: 90 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Prochymal™ Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD
Official Title  ICMJE A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal™ Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD
Brief Summary This is a Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of Prochymal™ versus placebo in combination with corticosteroids as initial therapy for acute GVHD. Corticosteroids have been the primary therapy for patients with previously untreated acute GVHD and the historical published data define an expected 35% complete response (CR) at Day +28 using this therapy.
Detailed Description

Subjects will be treated with a total of 6 infusions of investigational agent during the first 4 weeks of the study. Four infusions will be administered during the first two weeks (twice weekly), then two infusions administered during the next two weeks (once weekly). Subjects assigned to the active treatment group will receive Prochymal™. Subjects assigned to the non active treatment group will receive placebo (excipient, less cells). It is recommended that all subjects receive all six infusions. The discontinuation of investigational agent is allowed for GVHD worsening with subsequent need for salvage therapy. All infusions must be given at least 3 days apart.

Subjects will be evaluated for efficacy and safety until death, withdrawal or 90 study days after randomization, whichever occurs first. Study will be unblinded and data analyzed at Day 90 post 1st infusion (Day 0)following final subject enrollment. Subjects will be followed for safety for 12 months post 1st infusion (Day 0).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Graft Versus Host Disease
Intervention  ICMJE
  • Drug: Prochymal
    Subjects will be treated with a total of 6 infusions of investigational agent during the first 4 weeks of the study. Four infusions will be administered during the first two weeks (twice weekly), then two infusions administered during the next two weeks (once weekly). Subjects assigned to the active treatment group will receive Prochymal™ at 2 x 106 hMSC/kg per infusion.
  • Other: Placebo
    Subjects will be treated with a total of 6 infusions of investigational agent during the first 4 weeks of the study. Four infusions will be administered during the first two weeks (twice weekly), then two infusions administered during the next two weeks (once weekly). Subjects assigned to the non active treatment group will receive placebo (excipient, less cells). It is recommended that all subjects receive all six infusions. The discontinuation of investigational agent is allowed for GVHD worsening with subsequent need for salvage therapy. All infusions must be given at least 3 days apart.
Study Arms  ICMJE
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: Placebo
  • Active Comparator: 1
    Subjects assigned to the active treatment group will receive Prochymal™.
    Intervention: Drug: Prochymal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2007)
184
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must be 18 years to 70 years of age, inclusive
  • Subjects must have received an allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or cord blood or administered a donor leukocyte infusion.
  • Subjects must have newly diagnosed Grades B-D acute GVHD. Biopsy confirmation of GVHD is strongly recommended but not required. Randomization should not be delayed awaiting biopsy or pathology results.
  • Subjects must be randomized and treated with corticosteroid (1-2 mg/kg/d methylprednisolone, or equivalent) and Prochymal™/placebo within 72 hours of onset of acute GVHD.
  • Subjects must have adequate renal function as defined by: Calculated Creatinine Clearance of >30mL/min using the Cockroft-Gault equation
  • Subjects who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male subjects must use adequate contraception
  • Subject must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry
  • Subject (or legal representative where appropriate) must be capable of providing written informed consent.

Exclusion Criteria:

  • Subject has been previously treated with systemic immunosuppressive therapy for acute GVHD
  • Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject including uncontrolled infection, heart failure, pulmonary hypertension, etc.
  • Subjects may not receive any other investigational agents (not approved by the FDA for any indication) concurrently during study participation or within 30 days of randomization.
  • Subject has a known allergy to bovine or porcine products or DMSO
  • Subject has received a transplant for a solid tumor disease.
  • Subject requires more than 2L/min of oxygen to maintain stable SaO2 greater than or equal to 92%
  • Subject requires a renal dopamine dose greater than 1-3 mcg/kg/min to maintain renal blood flow associated with renal failure and improved urinary output.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00562497
Other Study ID Numbers  ICMJE 265
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mesoblast, Ltd. ( Mesoblast International Sàrl )
Study Sponsor  ICMJE Mesoblast International Sàrl
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rod L Monroy, Ph.D. Osiris Therapeutics, Inc.
PRS Account Mesoblast, Ltd.
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP