Transcript BMT CTN Protocol 0302 Informational Flyer

BMT CTN 0302
Randomized Phase II Trial of Four Acute GVHD Therapies
Objective
Eligibility
 Estimate the proportion of CR at Day 28
of therapy for newly diagnosed aGVHD
for each study agent used in
combination with corticosteroids
 aGVHD requiring systemic therapy
 No previous suppressive therapy except for
maximum 48 hours prior steroids
 ONTAK, Etancercept or Pentostatin within
previous 7 days
 Age ≥ 2 years
TREATMENT SCHEMA
HCT
(BM, PBSC, CB)
Acute GVHD
(diagnosed in past 48 hours)
Yes, requiring
systemic therapy
No
RANDOMIZATION
Prednisone, and
• Etanercept , or
• MMF*, or
• Ontak, or
• Pentostatin
Follow to Day 28
(weekly scoring and steroid
taper as tolerated)
If progressive GVHD within 7 days,
or no response within 14 days, treat
with alternative secondary agent
off study, follow for study endpoints
Study drug discontinued at Day 28,
MMF continued through steroid taper,
then begin MMF taper
Follow to Day 270
* Patients taking MMF within 7 days of GVHD onset will be randomized to Ontak, Pentostatin or Etanercept
and steroids.
To view the entire protocol, go to http://www.bmtctn.net
or the PDQ website at http://cancer.gov/clinicaltrials/BMTCTN-0302
This is a Phase II multi-center trial jointly sponsored by the NHLBI and NCI.
Version 3.0