Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Beclomethasone in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant for Hematologic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care, Treatment Active Not specified NCI FHCRC-2079.00 6493, NCT00489203

Objectives

1. Assess the efficacy of beclomethasone dipropionate in preventing acute graft-vs-host disease in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation for hematologic cancer.

Entry Criteria

Disease Characteristics:

• Diagnosis of a hematologic malignancy



• Meets all of the following criteria:
  • Undergoing or planning to undergo allogeneic hematopoietic stem cell transplantation with marrow or growth factor-mobilized peripheral blood stem cells from HLA-A, -B, -C, -DRB1, and HLA-DQB1-allele matched or single-allele or antigen mismatched related or unrelated donor
  • Received or planning to receive myeloablative pretransplant conditioning regimen with > 800 Gy total-body irradiation and cyclophosphamide OR high-dose busulfan and cyclophosphamide
  • Received or planning to receive methotrexate and tacrolimus for prevention of graft-vs-host disease (GVHD) post-transplant

Prior/Concurrent Therapy:

• See Disease Characteristics
• More than 3 months since prior rabbit antithymocyte globulin (ATG) or alemtuzumab
• No prior T-cell depletion or rabbit ATG to prevent acute GVHD
• No prior participation in another clinical trial with a primary endpoint related to acute GVHD
• No concurrent glucocorticoids at prednisone-equivalent doses > 0.2 mg/kg/day
• No concurrent cord blood transplantation

Patient Characteristics:

• Body weight ≥ 35 kg
• Able to tolerate oral administration of study drug during first 2 weeks post-transplant
• No concurrent incarceration
• No hospitalization at beginning of pretransplant conditioning regimen due to preexisting medical complications
• No known intolerance to beclomethasone dipropionate
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

Outcomes

Development of acute graft-vs-host disease (GVHD) with severity sufficient to require systemic immunosuppressive treatment on or before day 90 post-transplant

Safety
Feasibility
Cumulative glucocorticoid dose per kg body weight during the first 75 days post-transplant
Peak and average skin, liver, and gut morbidity stages and overall grades during the first 90 days post-transplant
Modified average acute GVHD index score during the first 90 days post-transplant
Cumulative incidence of systemic immunosuppressive treatment for acute GVHD at any time post-transplant
Cumulative incidence of topical therapy for acute GVHD, including psoralen and UV irradiation, hydrocortisone cream, topical tacrolimus, oral BDP, or oral swish and spit dexamethasone
Cumulative incidence of biopsy-proven gastrointestinal GVHD
Proportion of patients with grade IIa and/or IIb-IV GVHD
Cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment
Number of days in the hospital during the first 90 days post-transplant
Non-relapse mortality
Overall survival
Survival at 200 days post-transplant
Survival without recurrent malignancy

Outline

This is a randomized, double-blind, controlled study. Patients are stratified according to type of donor (related vs unrelated) and disease type and stage (chronic myeloid leukemia in chronic phase, refractory anemia without excess blasts, or other hematologic malignancy in remission vs more advanced malignancy). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral beclomethasone dipropionate 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.



• Arm II: Patients receive an oral placebo 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplantation. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Paul Martin, MD, Principal investigator		Ph: 206-667-4798

U.S.A.
New Jersey
	Hackensack
	Hackensack University Medical Center Cancer Center
		Scott Rowley, MD, FACP	Ph:  201-996-3872
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		Paul Martin, MD	Ph:  206-667-4798

Registry Information
Official Title		A Phase II Study to Evaluate the Efficacy of Oral Beclomethasone Dipropionate for Prevention of Acute GVHD After Hematopoietic Cell Transplantation with Myeloablative Conditioning Regimens
Trial Start Date		2007-03-28
Trial Completion Date		2009-12-01 (estimated)
Registered in ClinicalTrials.gov		NCT00489203
Date Submitted to PDQ		2007-05-07
Information Last Verified		2008-12-28
NCI Grant/Contract Number		CA18029-32, CA15704

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