To establish the safety and efficacy of two dose levels of ex-vivo cultured adult human mesenchymal stem cells (hMSCs) (Prochymal®) in participants experiencing acute GVHD, Grades II-IV, post hematopoietic stem cells (HSC) transplant.
Protocol 260 - Participants will be randomized with equal probability to the treatment arms (2 million cells/kilogram (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 will be administered on study Days 1 and 4. Participants will be followed for safety and efficacy until Day 28 after initiation of treatment with the investigational agent, or until withdrawal or death, whichever occurs first. Protocol 261- This study is designed as a long-term safety follow-up of participants who take part in the preceding clinical study of Prochymal® (Protocol 260) for the treatment of acute GVHD. Participants will be enrolled in Study 261 upon completion of the preceding Study 260.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
2 million hMSCs/kg actual body weight, IV on study Days 1 and 4
8 million hMSCs/kg actual body weight IV on study Days 1 and 4
Methylprednisolone 2 mg/kg administered intravenously.
St. Francis Hospital
Indianapolis, Indiana, United States
Kansas City Cancer Centers - BMT
Kansas City, Missouri, United States
The Cancer Center at Hackensack University
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Protocol 260 - Response by Day 28, also called Overall Response (OR). OR includes complete response (CR) and partial response (PR)
Time frame: 28 Days
Protocol 261-The incidence rate of different adverse events among participants treated with either dose of Prochymal® in the preceding study (Protocol No. 260).
Time frame: 2 Years
Protocol 260 - Partial Response or Improvement of GVHD by Day 28 in one or more organs involved with GVHD symptoms at Day 1,
Time frame: 28 Days
Protocol 260 - Time to best response of GVHD
Time frame: 28 Days
Protocol 260 - Time to improvement of GVHD in one or more organs
Time frame: 28 Days
Protocol 261 - Survival through study day 90
Time frame: 90 Days
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Prednisone 2.5 mg/kg administered orally.
Administered as prescribed by the caregiver.
Administered as prescribed by the caregiver.
Administered as prescribed by the caregiver.
Buffalo, New York, United States
Mt. Sinai Hospital
New York, New York, United States
University of Rochester
Rochester, New York, United States
New York Medical College
Valhalla, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin, FEC
Milwaukee, Wisconsin, United States