Graft Versus Host DiseasePhase 2NCT01616680
Brentuximab Vedotin in Treating Patients With Steroid-Resistant Acute Graft-Versus-Host Disease
A Phase 2 study testing brentuximab vedotin, laboratory biomarker analysis and pharmacological study in people with Graft Versus Host Disease, run by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium at 1 site in United States.
Trial summary
The purpose of this research is to test the safety and efficacy of brentuximab vedotin in patients with acute skin graft-versus-host disease (GVHD) Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- brentuximab vedotin, laboratory biomarker analysis and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2016
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with steroid-resistant stage 2 or 3 acute GVHD of the skin with or without involvement of other organs; patients must have received initial therapy with prednisone or methylprednisolone at a prednisone-equivalent dose of at least 1.0 mg/kg/day alone or combined with other agents, including psoralen and ultraviolet A (PUVA), with:
- Flare of rash involving at least 25% of the body surface at any time after starting prednisone for GVHD treatment, OR
- Rash involving more than 50% of the body surface persisting after at least 1 week of initial treatment, OR
- Rash involving at least 25% of the body surface persisting after at least 2 weeks of initial treatment
- Concomitant use of steroids is permitted; steroid dose should not have been increased within a week prior to enrollment
- Patient, guardian or legally authorized representative is able and willing to provide informed consent
- Willing to use effective contraception; both women of childbearing potential and men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days after the last dose of study drug
Who cannot join
- Prior second-line systemic treatment for GVHD
- Absolute neutrophil count (ANC) < 2000/μL
- Administration of growth factor in order to maintain the ANC > 2000/μL
- Platelet count < 30,000/μL, (unsupported)
- Serum total bilirubin concentration > upper limit of normal (ULN)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3X ULN
Show all 16Show fewer
- Calculated creatinine clearance < 60 ml/min
- Peripheral neuropathy: clinical total neuropathy score (TNS) score > 2
- Any Grade 3 or higher uncontrolled active infection within 1 week before enrollment
- Bullous formation or desquamation related to GVHD (stage 4 skin GVHD)
- Evidence of recurrent/persistent malignancy by cytogenetics, histology or flow cytometry
- GVHD after donor lymphocyte infusion (DLI)
- Clinical manifestations of chronic skin GVHD
- Women who are pregnant or lactating; women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days before the first dose of brentuximab vedotin; woman of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
- Patients with a known hypersensitivity to brentuximab vedotin
- History of Progressive multifocal leukoencephalopathy (PML)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Phase II Study to Evaluate the Efficacy of Brentuximab Vedotin in Patients With Steroid-Resistant Acute GVHD
The purpose of this research is to test the safety and efficacy of brentuximab vedotin in patients with acute skin graft-versus-host disease (GVHD)
Read the detailed description
PRIMARY OBJECTIVES:
- Determine whether the complete and partial response rate of steroid-resistant skin GVHD exceeds 25% after administration of brentuximab vedotin.
SECONDARY OBJECTIVES:
- Evaluate the effect of brentuximab vedotin on the clinical manifestations of acute GVHD of the liver and gastrointestinal tract.
II. Determine the incidence and degree of brentuximab vedotin-related toxicity when administered after allogeneic hematopoietic cell transplantation (HCT).
III. Evaluate cluster of differentiation (CD)30 expression in skin biopsies before and after administration of brentuximab vedotin.
IV. Enumerate CD30 expressing lymphocytes in the blood and measure the concentration of soluble CD30 in serum before and after administration of brentuximab vedotin.
- Determine whether changes in CD30 expression in skin biopsies or blood lymphocytes or the concentration of CD30 in serum before and after administration of brentuximab vedotin are correlated with changes in skin GVHD stage.
VI. Evaluate pharmacokinetics (PK) of brentuximab vedotin in patients after allogeneic HCT.
OUTLINE: This is a dose escalation study.
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and 15.
After completion of study treatment, patients are followed up for 30 days.
- Conditions
- Graft Versus Host Disease
- Being tested
- brentuximab vedotin, laboratory biomarker analysis, pharmacological study
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brentuximab vedotinDrug
Also called Adcetris, anti-CD30 ADC SGN-35, anti-CD30 antibody-drug conjugate SGN-35, antibody-drug conjugate SGN-35
Given IV
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (brentuximab vedotin) | Experimental | Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Receives: Drug: brentuximab vedotin; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial and complete response rates of steroid-resistant acute skin GVHD following administration of brentuximab vedotin
Measured: Up to day 28
Secondary outcomes (2)
Complete and partial response rates of gut and liver acute GVHD after administration of brentuximab vedotin
Measured: Up to day 28
Incidence and severity of brentuximab vedotin-related toxicity after allogeneic HCT defined graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4
Measured: Assessed up to day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Merav Bar, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616680
- Sponsor's protocol ID
- 2589.00
- Other IDs
- NCI-2012-00921
- Status last verified
- Jun 2013
- First submitted
- 7 Jun 2012
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy of Brentuximab Vedotin in Patients With Steroid-Resistant Acute GVHD
- ClinicalTrials.gov ID
- NCT01616680
- Acronym / sponsor ID
- 2589.00
- Conditions
- Graft Versus Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2012
- Primary completion
- Jun 2016 (estimated)
- First posted
- 12 Jun 2012 (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.
The purpose of this research is to test the safety and efficacy of brentuximab vedotin in patients with acute skin graft-versus-host disease (GVHD)
Detailed description
PRIMARY OBJECTIVES:
- Determine whether the complete and partial response rate of steroid-resistant skin GVHD exceeds 25% after administration of brentuximab vedotin.
SECONDARY OBJECTIVES:
- Evaluate the effect of brentuximab vedotin on the clinical manifestations of acute GVHD of the liver and gastrointestinal tract.
II. Determine the incidence and degree of brentuximab vedotin-related toxicity when administered after allogeneic hematopoietic cell transplantation (HCT).
III. Evaluate cluster of differentiation (CD)30 expression in skin biopsies before and after administration of brentuximab vedotin.
IV. Enumerate CD30 expressing lymphocytes in the blood and measure the concentration of soluble CD30 in serum before and after administration of brentuximab vedotin.
- Determine whether changes in CD30 expression in skin biopsies or blood lymphocytes or the concentration of CD30 in serum before and after administration of brentuximab vedotin are correlated with changes in skin GVHD stage.
VI. Evaluate pharmacokinetics (PK) of brentuximab vedotin in patients after allogeneic HCT.
OUTLINE: This is a dose escalation study.
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and 15.
After completion of study treatment, patients are followed up for 30 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (brentuximab vedotin) | Experimental | Drug: brentuximab vedotin, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with steroid-resistant stage 2 or 3 acute GVHD of the skin with or without involvement of other organs; patients must have received initial therapy with prednisone or methylprednisolone at a prednisone-equivalent dose of at least 1.0 mg/kg/day alone or combined with other agents, including psoralen and ultraviolet A (PUVA), with:
- Concomitant use of steroids is permitted; steroid dose should not have been increased within a week prior to enrollment
- Patient, guardian or legally authorized representative is able and willing to provide informed consent
- Willing to use effective contraception; both women of childbearing potential and men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days after the last dose of study drug
Key exclusion criteria (16 listed)
- Prior second-line systemic treatment for GVHD
- Absolute neutrophil count (ANC) < 2000/μL
- Administration of growth factor in order to maintain the ANC > 2000/μL
- Platelet count < 30,000/μL, (unsupported)
- Serum total bilirubin concentration > upper limit of normal (ULN)
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 |
|---|---|---|
| brentuximab vedotinAlso: Adcetris, anti-CD30 ADC SGN-35, anti-CD30 antibody-drug conjugate SGN-35, antibody-drug conjugate SGN-35Given IV | Drug | Supportive care (brentuximab vedotin) |
| laboratory biomarker analysisCorrelative studies | Other | Supportive care (brentuximab vedotin) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Supportive care (brentuximab vedotin) |
Primary outcome
Partial and complete response rates of steroid-resistant acute skin GVHD following administration of brentuximab vedotin
Time frame: Up to day 28
2 secondary outcomes
Complete and partial response rates of gut and liver acute GVHD after administration of brentuximab vedotin
Time frame: Up to day 28
Incidence and severity of brentuximab vedotin-related toxicity after allogeneic HCT defined graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4
Time frame: Assessed up to day 45
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
Related trials for Graft Versus Host Disease
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
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.
Merav Bar principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brentuximab vedotin, laboratory biomarker analysis and pharmacological study in people with Graft Versus Host Disease, run by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium at 1 site 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 7 inclusion and 16 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: withdrawn, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Partial and complete response rates of steroid-resistant acute skin GVHD following administration of brentuximab vedotin (time frame: Up to day 28). 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 27 Jun 2013.