MDACC Study Summary 2007-0915

Study Summary
No. 2007-0915:.......Leukemia; Lymphoma; Myeloma......Partow Kebriaei......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2007-0915

Study Title:	A Phase III Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion in Combination with Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD

Physician

New Patient Referral



Name:	Partow Kebriaei	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8750 Contact us about clinical trials

General Information



Disease Group:	Leukemia Lymphoma Myeloma	Supported By:	Osiris Therapeutics, Inc.

Phase of Study:	Phase III	Return Visit:	Patients will be assessed weekly from day 7 through day 56 (+/- 1 day), then day 90 (+/- 7 day), and then at 12months (+/- 30 days) from time of first infusion of investigational agent.

Treatment Agents:	Corticosteroids Mesenchymal Stem Cells	Home Care:	Intravenous fluids, antibiotics may be necessary through home care agencies.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Depends on how quickly the patient's GVHD symptoms improve; may range from 1 to several weeks.


Description/ Intervention:	The goal of this clinical research study is to learn if Prochymal in combination with a type of corticosteroids can help to control acute GVHD. The safety of Prochymal will also be studied.

Study Objectives / Outcomes

1. To evaluate the efficacy of ProchymalŽ in combination with corticosteroids, versus placebo in
combination with corticosteroids, in subjects experiencing newly diagnosed Grades B-D acute graft
versus host disease (GVHD).
2. To gather additional information on the safety of ProchymalŽ in subjects experiencing newly
diagnosed Grades B-D acute GVHD.

Study Status Information



Study Activation / Registration Date:	08/12/2008

IRB Review and Approval Date:	08/12/2008

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	184

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Subjects must be 18 years to 70 years of age, inclusive.

2) Subjects must have received an allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or cord blood

3) 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. Grading system for GVHD is standardized and detailed in appendix to protocol.

4) Subjects must be randomized and treated with corticosteroid 2 mg/kg/d methylprednisolone, or 2.5 mg/kg/d Prednisone, or equivalent) and ProchymalŽ/placebo within 72 hours of onset of Grades B-D acute GVHD requiring systemic immunosupppression.

5) Subjects must have adequate renal function as defined by: Calculated Creatinine Clearance of >30mL/min using the Cockroft-Gault equation.

6) Subjects who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male subjects must use adequate contraception.

7) Subject must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry.

8) Subject (or legal representative where appropriate) must be capable of providing written informed consent.

Exclusion Criteria:

1) Subject has been previously treated with systemic immunosuppressive therapy for acute GVHD.

2) Subject who have developed acute GVHD after a Donor Leukocyte infustion (DLI).

3) 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.

4) 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.

5) Subject has a known allergy to bovine or porcine products or DMSO (dimethyl sulfoxide).

6) Subject has received a transplant for a solid tumor disease.

7) Subject requires more than 2L/min of oxygen or an estimated FiO2 of 28% to maintain stable SaO2 greater than or equal to 92%.

8) Subject requires a renal dopamine dose greater than 3 mcg/kg/min to maintain renal blood flow associated with decreased urinary output and renal failure.

9) Subjects who have received corticosteroids, prednisone doses > 40 mg/day, for immune mediated disorders (e.g., systemic lupus erythematosus, nephritic syndrome).

Links

Registration Number: NCT00562497
Study Information on Clinical Trials Registry (clinicaltrials.gov)