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

February 1, 2021 updated by: Fred Hutchinson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: beclomethasone dipropionate
Given orally
Other Names:
  • Qvar
  • Beconase
  • BECLOMETH
  • Beclovent
  • Vancenase
  • Vanceril
Drug: tacrolimus
Given after transplant
Other Names:
  • Prograf
  • FK 506
  • Protopic
  • Advagraf
Drug: methotrexate
Given after transplant
Other Names:
  • Abitrexate
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Procedure: allogeneic hematopoietic stem cell transplantation
Undergo stem cell 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.
Drug: placebo
Given orally
Other Names:
  • PLCB
Drug: tacrolimus
Given after transplant
Other Names:
  • Prograf
  • FK 506
  • Protopic
  • Advagraf
Drug: methotrexate
Given after transplant
Other Names:
  • Abitrexate
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Procedure: allogeneic hematopoietic stem cell transplantation
Undergo stem cell transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
On or before day 90 after the transplant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Investigators

  • Principal Investigator: Paul Martin, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2079.00
  • NCI-2009-01544

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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