Clinical Trial: Etanercept, Mycophenolate Mofetil, Denileukin Diftitox, or Pentostatin Combined With Prednisone or Methylprednisolone in Treating Patients With Acute Graft-Versus-Host Disease Who Have Undergone a Previous Donor Stem Cell Transplant

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) November 2005

Sponsors and Collaborators: Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00253656

Purpose

RATIONALE: Etanercept, mycophenolate mofetil, denileukin diftitox, pentostatin, prednisone, or methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This randomized phase II trial is studying etanercept, mycophenolate mofetil, denileukin diftitox, or pentostatin combined with prednisone or methylprednisolone to compare how well they work in treating patients with acute graft-versus-host disease who have undergone a previous donor stem cell transplant.

Condition Intervention Phase
Cancer
Graft Versus Host Disease
 Drug: denileukin diftitox
 Drug: etanercept
 Drug: methylprednisolone
 Drug: mycophenolate mofetil
 Drug: pentostatin
 Drug: prednisone
 Procedure: biological response modifier therapy
 Procedure: complications of therapy assessment/management
 Procedure: graft versus host disease prophylaxis/therapy
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapies;   Immune System and Disorders
Genetics Home Reference related topics:  Cancer;   Cancer--Living with Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study of Etanercept Versus Mycophenolate Mofetil Versus Denileukin Diftitox Versus Pentostatin in Combination With Prednisone or Methylprednisolone in Patients With Acute Graft-Versus-Host Disease Who Have Undergone a Prior Allogeneic Hematopoietic Stem Cell Transplant

Further study details as provided by National Cancer Institute (NCI):

OBJECTIVES:

Primary

Secondary

  • Compare the 4-week partial response rate, mixed response rate, and disease progression in patients treated with these regimens.
  • Compare the 2-week treatment failure rate (no response, progression, or mortality) in patients treated with these regimens.
  • Compare the incidence of GVHD flares requiring increased therapy before 90 days in these patients.
  • Compare the incidence of discontinuation of immune suppression without flare by days 90, 180, and 270 post therapy in these patients.
  • Compare the incidence of chronic GVHD by 9 months in patients treated with these regimens.
  • Compare the 6- and 9-month overall survival post initiation of therapy in these patients.
  • Compare the incidence of systemic infections within 3 months of initiation of therapy in these patients.
  • Compare the incidence of Epstein-Barr virus-associated lymphoma in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

After completion of study treatment, patients are followed periodically for 9 months.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  10 Years and above,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

Hepatic

  • Not specified

Renal

  • Creatinine clearance > 30 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of intolerance to any of the study drugs
  • No uncontrolled infection
  • Bacterial or viral infections must be controlled by definitive therapy and show no signs of progressing infection* within 72 hours of study entry
  • Fungal infections must be controlled with definitive systemic antifungal therapy and show no signs of progressing infection* within 1 week of study entry NOTE: *Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persistent fever without other signs or symptoms will not be interpreted as progressing infection.

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • More than 7 days since prior denileukin diftitox
  • More than 7 days since prior etanercept
  • Prior antithymocyte globulin allowed

Chemotherapy

  • More than 7 days since prior pentostatin
  • Prior methotrexate allowed

Endocrine therapy

Other

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00253656


Study chairs or principal investigators

Daniel J. Weisdorf, MD,  Study Chair,  University of Minnesota   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000449983; BMTCTN-0302; JHOC-05040403; JHOC-J0519
Last Updated:  December 8, 2005
Record first received:  November 11, 2005
ClinicalTrials.gov Identifier:  NCT00253656
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10



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