Graft-Versus-Host DiseasePhase 1NCT00806208
Trial for Evaluation of Safety of Escalating Dose Levels of MEDI-507 in Patients for Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)
A Phase 1 study testing MEDI-507 in people with Graft-Versus-Host Disease, run by MedImmune LLC at 3 sites in United States.
Trial summary
A trial to assess safety of four doses of MEDI 507 combined with another drug for initial treatment of at least Grade II acute Graft-vs-Host Disease in recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft-Versus-Host Disease
- What is being tested?
- MEDI-507
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 1999to Mar 2000
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- allogeneic bone marrow or hematopoietic stem cell graft recipients
- acute GvHD of at least Grade II severity
- receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) within eight to 24 hours prior to initial receipt of study drug
- evidence of engraftment (ANC over 1,000 cells/mm3)
- histologic evidence of GvHD from biopsy performed during the current episode
- receipt of GvHD prophylaxis of methotrexate, tacrolimus or cyclosporine
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- age at least 18 years
- body weight under 130 kg
- Both males and females are eligible, but females of childbearing potential, unless previously surgically sterilized, agree to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, Norplant7 or DepoProvera7) beginning with the first study injection and continuing through 60 days after the final study injection.
Who cannot join
- previous receipt of MEDI 507
- diagnosis of chronic GvHD
- previous treatment with any anti-T-cell monoclonal antibodies such as OKT73 or daclizumab (Zenapax7)
- receipt of antithymocyte globulin (ATGAM7 or other ATG) within 14 days
- treatment with more than 0.3 mg/kg/day of methylprednisolone (or equivalent corticosteroid) for more than 72 hours for the treatment of GvHD
- intolerance or history of intolerance to corticosteroids such that it is unlikely the patient will be able to complete at least ten days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or equivalent)
- more than one allogeneic bone marrow or hematopoietic stem cell allograft
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor Institute of Transplant Sciences
Dallas, Texas, 75246
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Washington University Medical Center
St Louis, Missouri, 63110
About this study
Official title: Phase I Evaluation of Safety, Pharmacokinetics and Activity of Escalating Dose Levels of MEDI 507 in Patients Receiving Methylprednisolone for Initial Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)
A trial to assess safety of four doses of MEDI 507 combined with another drug for initial treatment of at least Grade II acute Graft-vs-Host Disease in recipients.
Read the detailed description
The primary objective of this study is to assess safety of four dose levels of MEDI 507 combined with methylprednisolone for initial treatment of at least Grade II acute GvHD in stem cell or bone marrow allograft recipients.
- Conditions
- Graft-Versus-Host Disease
- Being tested
- MEDI-507, Placebo
- 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.
MEDI-507Drug
0.012 mg/kg MEDI 507 and Methylprednisolone
MEDI-507Drug
0.04 mg/kg MEDI 507 and Methylprednisolone
MEDI-507Drug
0.12 mg/kg MEDI 507 and Methylprednisolone
MEDI-507Drug
0.4 mg/kg MEDI 507 and Methylprednisolone
PlaceboOther
Placebo IV (alternative) study days 0, 3,6, and 9
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI 507 and Methylprednisolone Receives: Drug: MEDI-507 |
| 2 | Active comparator | MEDI-507 and Methylprednisolone Receives: Drug: MEDI-507 |
| 3 | Active comparator | MEDI-507 and Methylprednisolone Receives: Drug: MEDI-507 |
| 4 | Active comparator | MEDI-507 and Methylprednisolone Receives: Drug: MEDI-507 |
| 5 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety; first infusion of study drug
Measured: Through Study Day 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startJan 1999
- Primary completionJan 2000
- Study completionMar 2000
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J. Bruce McClain, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806208
- Sponsor's protocol ID
- MI-CP046
- Status last verified
- Dec 2008
- First submitted
- 9 Dec 2008
- Last updated
- 11 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Safety, Pharmacokinetics and Activity of Escalating Dose Levels of MEDI 507 in Patients Receiving Methylprednisolone for Initial Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)
- ClinicalTrials.gov ID
- NCT00806208
- Acronym / sponsor ID
- MI-CP046
- Conditions
- Graft-Versus-Host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Jan 2000 (actual)
- Study completion
- Mar 2000 (actual)
- First posted
- 10 Dec 2008 (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.
A trial to assess safety of four doses of MEDI 507 combined with another drug for initial treatment of at least Grade II acute Graft-vs-Host Disease in recipients.
Detailed description
The primary objective of this study is to assess safety of four dose levels of MEDI 507 combined with methylprednisolone for initial treatment of at least Grade II acute GvHD in stem cell or bone marrow allograft recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MEDI-507MEDI 507 and Methylprednisolone |
| 2 | Active comparator | Drug: MEDI-507MEDI-507 and Methylprednisolone |
| 3 | Active comparator | Drug: MEDI-507MEDI-507 and Methylprednisolone |
| 4 | Active comparator | Drug: MEDI-507MEDI-507 and Methylprednisolone |
| 5 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- allogeneic bone marrow or hematopoietic stem cell graft recipients
- acute GvHD of at least Grade II severity
- receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) within eight to 24 hours prior to initial receipt of study drug
- evidence of engraftment (ANC over 1,000 cells/mm3)
- histologic evidence of GvHD from biopsy performed during the current episode
Key exclusion criteria (7 listed)
- previous receipt of MEDI 507
- diagnosis of chronic GvHD
- previous treatment with any anti-T-cell monoclonal antibodies such as OKT73 or daclizumab (Zenapax7)
- receipt of antithymocyte globulin (ATGAM7 or other ATG) within 14 days
- treatment with more than 0.3 mg/kg/day of methylprednisolone (or equivalent corticosteroid) for more than 72 hours for the treatment of GvHD
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 |
|---|---|---|
| MEDI-5070.012 mg/kg MEDI 507 and Methylprednisolone | Drug | 1 |
| MEDI-5070.04 mg/kg MEDI 507 and Methylprednisolone | Drug | 2 |
| MEDI-5070.12 mg/kg MEDI 507 and Methylprednisolone | Drug | 3 |
| MEDI-5070.4 mg/kg MEDI 507 and Methylprednisolone | Drug | 4 |
| PlaceboPlacebo IV (alternative) study days 0, 3,6, and 9 | Other | 5 |
Primary outcome
Safety; first infusion of study drug
Time frame: Through Study Day 44
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 11 Dec 2008.
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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.
J. Bruce McClain, M.D. study director
MedImmune LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-507 in people with Graft-Versus-Host Disease, run by MedImmune LLC at 3 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 9 inclusion and 7 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 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety; first infusion of study drug (time frame: Through Study Day 44). 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 11 Dec 2008.