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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 . If progressive GVHD within 7 days, or no response within 14 days, treat

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bmt ctn 0302 randomized phase ii trial of four acute gvhd therapies

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

If progressive GVHD within 7 days,

or no response within 14 days, treat

with alternative secondary agent

off study, follow for study endpoints

Follow to Day 28(weekly scoring and steroid

taper as tolerated)

Study drug discontinued at Day 28,

MMF continued through steroid taper,

then begin MMF taper

Follow to Day 270

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

* 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