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A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) For the Treatment of aGVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation


Phase 2
18 Years
70 Years
Not Enrolling
Both
Graft vs Host Disease

Thank you

Trial Information

A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) For the Treatment of aGVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation


Protocol 260 - Subjects will be randomized with equal probability to the treatment arms (2
million cells/kg of Prochymal or 8 million cells/kg of Prochymal) using a stratified block
design. The stratification factor is acute GVHD grade. For the purpose of stratification,
the GVHD grades are II and III-IV. Treatment with investigational agent was administered on
study Days 1 and 4. Patients were followed for safety and efficacy until Day 28 after
initiation of treatment with the investigational agent, or until withdrawal or death,
whichever occurred first.

Protocol 261 - Subjects were evaluated for safety until 2 years from Day 1 of the preceding
Prochymal® Protocol No. 260 until withdrawal or death.


Protocol 260

Inclusion Criteria:



- Subjects must be 18 to 70 years of age inclusive

- If female and of child-bearing age, subjects must be non-pregnant, not breast
feeding, and use adequate contraception. Males must use adequate contraception.

- Subject must have newly diagnosed, Grade II-IV acute GVHD requiring therapy. Biopsy
for confirmation of GVHD is not mandatory, but is recommended when feasible.
Enrollment should not be delayed awaiting biopsy results.

- Subject must have received either full or reduced intensity myeloablative regimens
followed by an allogeneic hematopoietic stem cell transplant using bone marrow,
peripheral blood stem cell, or cord blood, including DLI

- Subjects must have minimal renal and hepatic function as defined by:

* Calculated creatinine clearance (CLcr) of > 30 mL/min using the Cockroft-Gault
equation

- Subject must be available for all specified assessments at the study site through
study Day 28.

- Subjects must provide written informed consent and authorization for use and
disclosure of protected health information (PHI).

Protocol 260 Exclusion Criteria:

- Subject has received previous treatment for Grade II-IV acute GVHD (except as noted
in criterion 2).

- Subject has been treated for GVHD with methylprednisolone, > 2mg/kg/day, for more
than 72 hours prior to receiving Prochymal™

- Subject has uncontrolled alcohol or substance abuse within 6 months of randomization.

- Subject has received an investigational agent (not approved by FDA for marketed use
in any indication) within 30 days of randomization. Subjects may not receive an
investigational agent during the 28-day study period

- 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
(e.g., uncontrolled infection, right heart failure, pulmonary hypertension, etc.)

- Subject has unstable arrhythmia

- Subject is unwilling to sign consent form for the long-term follow-up study, protocol
No. 261

- Subject has a known allergy to bovine or porcine products.

- Subject had received transplant for a solid tumor disease.

Protocol 261

Inclusion Criteria:



- Subject must have received any treatment with the Investigational Agent in the
preceding Prochymal® study.

- Subject must have completed their participation in a preceding Prochymal® study.

- If female and of child-bearing age, subjects must be non-pregnant, not
breast-feeding, and use adequate contraception. Male subjects must use adequate
contraception.

- Subject must provide written informed consent and written authorization for
disclosure and use of PHI.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Protocol 260 - Response by Day 28, also called Overall Response. Overall response. includes complete response (CR) and partial response (PR)

Outcome Time Frame:

28 Days

Safety Issue:

No

Principal Investigator

Philip McCarthy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

260-261

NCT ID:

NCT00136903

Start Date:

February 2005

Completion Date:

July 2008

Related Keywords:

  • Graft Vs Host Disease
  • Graft vs Host Disease
  • GVHD
  • Graft Versus Host Disease
  • Bone marrow transplant
  • Stem cells
  • Mesenchymal stem cells
  • Adult stem cells
  • Leukemia
  • Lymphoma
  • Graft vs Host Disease

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
New York Medical CollegeValhalla, New York  10595
University of RochesterRochester, New York  14642
The Cancer Center at Hackensack UniversityHackensack, New Jersey  07601
St. Francis HospitalIndianapolis, Indiana  46237
Kansas City Cancer Centers - BMTKansas City, Missouri  64111
Mt. Sinai HospitalNew York, New York  10029
Medical College of Wisconsin, FECMilwaukee, Wisconsin  53226