Hematopoietic/Lymphoid CancerPhase 2NCT00489203

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

A Phase 2 study testing beclomethasone dipropionate, tacrolimus and methotrexate in people with Hematopoietic/Lymphoid Cancer and Accelerated Phase Chronic Myelogenous Leukemia, run by Fred Hutchinson Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
What is being tested?: beclomethasone dipropionate, tacrolimus and methotrexate
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 2 sitesUnited States
Study dates: Apr 2007to Nov 2010
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

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.

Conditions: Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Being tested: beclomethasone dipropionate, placebo, tacrolimus, methotrexate, allogeneic hematopoietic stem cell transplantation
Medical subject headings: Hematologic Neoplasms, Leukemia, Myeloid, Accelerated Phase, Congenital Abnormalities, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis, Pdgfra-Associated Chronic Eosinophilic Leukemia, Leukemia, Myelomonocytic, Chronic, Leukemia, Neutrophilic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

beclomethasone dipropionateDrug
Also called BECLOMETH, Beclovent, Beconase, Qvar
Given orally
placeboDrug
Also called PLCB
Given orally
tacrolimusDrug
Also called Advagraf, FK 506, Prograf, Protopic
Given after transplant
methotrexateDrug
Also called Abitrexate, amethopterin, Folex, methylaminopterin
Given after transplant
allogeneic hematopoietic stem cell transplantationProcedure or surgery
Undergo stem cell transplant

Study groups in NCT00489203
Study group	Role	What they receive
Arm I	Experimental	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. Receives: Drug: beclomethasone dipropionate; Drug: tacrolimus; Drug: methotrexate; Procedure: allogeneic hematopoietic stem cell transplantation
Arm II	Active comparator	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. Receives: Drug: placebo; Drug: tacrolimus; Drug: methotrexate; Procedure: allogeneic hematopoietic stem cell transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (16)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Nov 2010

First posted21 Jun 2007 (estimated)
Study startApr 2007
Primary completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hematopoietic/Lymphoid CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00489203
Sponsor's protocol ID: 2079.00
Other IDs: NCI-2009-01544
Status last verified: Mar 2015
First submitted: 20 Jun 2007
Last updated: 3 Feb 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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