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

Phase 2

Completed

• Conditions: Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Hematopoietic/Lymphoid Cancer; Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Childhood Acute Myeloid Leukemia in Remission; Chronic Eosinophilic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Contiguous Stage II Grade 3 Follicular Lymphoma
• Interventions: Drug: placebo; Drug: beclomethasone dipropionate; Drug: tacrolimus; Drug: methotrexate; Procedure: allogeneic hematopoietic stem cell transplantation

• Registration Number: NCT00489203
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-21
• Primary Completion: 2010-11
• Disposition First Submitted: 2011-09-21
• Disposition First Submitted QC: 2011-09-21
• Disposition First Posted: 2011-10-05
• Status Verified: 2015-03
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	placebo	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.
Arm II	allogeneic hematopoietic stem cell transplantation	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.
Arm I	methotrexate	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 I	allogeneic hematopoietic stem cell transplantation	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 I	tacrolimus	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 I	beclomethasone dipropionate	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	tacrolimus	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.
Arm II	methotrexate	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States