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.
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
- Are there results?
- None posted in the registry
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
Show all 12Show fewer
- 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
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 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.
- 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.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Martin, Principal investigator, Fred Hutchinson Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00489203
- Acronym / sponsor ID
- 2079.00
- 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)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2010 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: beclomethasone dipropionate, Drug: tacrolimus, Drug: methotrexate, Procedure: allogeneic hematopoietic stem cell transplantationPatients 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 | Active comparator | Drug: placebo, Drug: tacrolimus, Drug: methotrexate, Procedure: allogeneic hematopoietic stem cell transplantationPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beclomethasone dipropionateAlso: BECLOMETH, Beclovent, Beconase, QvarGiven orally | Drug | Arm I |
| placeboAlso: PLCBGiven orally | Drug | Arm II |
| tacrolimusAlso: Advagraf, FK 506, Prograf, ProtopicGiven after transplant | Drug | Arm I, Arm II |
| methotrexateAlso: Abitrexate, amethopterin, Folex, methylaminopterinGiven after transplant | Drug | Arm I, Arm II |
| allogeneic hematopoietic stem cell transplantationUndergo stem cell transplant | Procedure or surgery | Arm I, Arm II |
Primary outcome
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
16 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Martin principal investigator
Fred Hutchinson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.