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

Overview

RATIONALE: Beclomethasone dipropionate may be effective in preventing acute graft-versus-host disease in patients undergoing a stem cell transplant for hematologic cancer. PURPOSE: This randomized phase II trial is studying how well beclomethasone dipropionate works in preventing acute graft-versus-host disease in patients undergoing a donor stem cell transplant for hematologic cancer.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2010

Detailed Description

PRIMARY OBJECTIVES: I. Assess the efficacy of oral BDP for prevention of acute GVHD after allogeneic hematopoietic cell transplantation with myeloablative conditioning regimens. OUTLINE: 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 oral placebo 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. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Interventions

  • Drug: beclomethasone dipropionate
    • Given orally
  • Drug: placebo
    • Given orally
  • Drug: tacrolimus
    • Given after transplant
  • Drug: methotrexate
    • Given after transplant
  • Procedure: allogeneic hematopoietic stem cell transplantation
    • Undergo stem cell transplant

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: Arm II
    • Patients receive oral placebo 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.

Clinical Trial Outcome Measures

Primary Measures

  • Development of acute graft-versus-host disease (GVHD) with severity sufficient to require systemic immunosuppressive treatment
    • Time Frame: On or before day 90 after the transplant

Secondary Measures

  • Cumulative glucocorticoid dose (measured as prednisone equivalents) per kg body weight
    • Time Frame: First 75 days after HCT
  • Peak and average skin, liver and gut morbidity stages and overall grades
    • Time Frame: To day 90 after HCT
  • Modified average acute GVHD index score
    • Time Frame: To day 90 after HCT
  • Cumulative incidence of systemic immunosuppressive treatment for acute GVHD
    • Time Frame: At any time after HCT
  • 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
    • Time Frame: On or before day 90 after the transplant
  • Cumulative incidence of biopsy-proven gastrointestinal GVHD
    • Time Frame: On or before day 90 after the transplant
  • Proportion of patients with grade IIa GVHD
    • Time Frame: On or before day 90 after the transplant
  • Proportions of patients with grades IIa and IIb – IV GVHD
    • Time Frame: On or before day 90 after the transplant
  • Cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment
    • Time Frame: At any time after HCT
  • Number of days in the hospital
    • Time Frame: During the first 90 days after HCT
  • Non-relapse mortality
    • Time Frame: At any time after HCT
  • Overall survival
    • Time Frame: At any time after HCT
  • Survival
    • Time Frame: At 200 days after HCT
  • Safety
    • Time Frame: On or before day 90 after the transplant
  • Feasibility
    • Time Frame: First 75 days after HCT
  • Survival without recurrent malignancy
    • Time Frame: At any time after HCT

Participating in This Clinical Trial

Inclusion

  • Allogeneic HCT with marrow or growth-factor mobilized blood cells from an HLA-A, B, C, DRB1, and HLA-DQB1-allele matched or single-allele or antigen mismatched related or unrelated donor – Use of myeloablative pre-transplant conditioning regimen with > 800 cGy total body irradiation and cyclophosphamide, or high-dose busulfan and cyclophosphamide – Use of methotrexate and tacrolimus for prevention of GVHD after allogeneic HCT – Informed consent document signed Exclusion – Cord blood transplant recipients – Use of T cell depletion or rabbit antithymocyte globulin to prevent acute GVHD – Treatment with rabbit antithymocyte globulin or alemtuzumab within 3 months before the date of HCT – Participation in another therapeutic trial where the primary endpoint is related to acute GVHD – Hospitalization at the beginning of the pre-transplant conditioning regimen because of pre-existing medical complications – Glucocorticoid treatment at prednisone-equivalent doses > 0.2 mg/kg/day – Known intolerance to BDP – Anticipated inability to tolerate oral administration of study drug tablets for any reason during the first two weeks after HCT – Body weight < 35 kg (lower-dose formulations are not available for subjects with lower body weight) – Pregnancy or breast feeding – Women of child-bearing potential who are unwilling to use a reliable method of contraception – Incarceration

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fred Hutchinson Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul Martin, Principal Investigator, Fred Hutchinson Cancer Center

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