Graft Versus Host DiseasePhase 1Pediatric GvHDNCT00813618
Study of MEDI 507 in the Treatment of Pediatric Patients
A Phase 1 study testing MEDI-507 in people with Graft Versus Host Disease, run by MedImmune LLC at 6 sites in United States.
Trial summary
To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone marrow allograft recipients who have at least Grade II GvHD. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- 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?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 1999to Aug 2004
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Allogeneic BMT or SCT recipients
- Acute GvHD of at least Grade II severity
- Age 2 to 17 years
- Evidence of engraftment (ANC over 500 cells/mm3 on two consecutive days within seven days before study entry)
- Receipt of GvHD prophylaxis regimen including methotrexate, tacrolimus or cyclosporine
- Receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) between eight and 24 hours prior to the first MEDI-507 dose for GvHD treatment
- Both males and females are eligible, but sexually active females at risk of pregnancy of childbearing potential must agree to use an effective method of avoiding pregnancy (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) beginning 30 days before the first study infusion and continuing through 60 days after the final study infusion.
Who cannot join
- Treatment of acute GvHD with methylprednisolone (or equivalent corticosteroid) at a total dose exceeding 14 mg/kg (or equivalent) over a seven day period (for example, 2 mg/kg/day for seven days)
- Previous receipt of MEDI 507
- Previous treatment with any anti-T cell monoclonal antibodies, such as OKT3, daclizumab (Zenapax), or basiliximab (Simulect)
- Treatment with anti-thymocyte globulin (ATG, ATGAM or others) within 14 days
- More than one allogeneic bone marrow or hematopoietic stem cell allograft
- Use of other investigational agents within 30 days (this does not include the use of licensed agents for indications not listed in the package insert) or current participation in a research protocol in which an investigational agent was administered
Show all 15Show fewer
- Any of the following clinical settings or diagnoses:
- documented or presumed significant active infection
- pregnancy or nursing mother
- evidence of infection with HIV-1, hepatitis B or C virus
- hemodialysis or chronic peritoneal dialysis
- use of a ventilator
- chronic GvHD
- active veno-occlusive disease of the liver
- moribund patient
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Univ. of Michigan Medical Center
Ann Arbor, Michigan, 48109
Children's Hospital
Birmingham, Alabama, 35233
Children's Memorial Hospital
Chicago, Illinois, 606014
Hackensack U. Medical Center
Hackensack, New Jersey, 07601
Children's Hospital of Orange County
Orange, California, 92868
The Children's Hosp. of Phila., Abramson Ped. Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase I Study of MEDI 507 in the Treatment of Pediatric Patients With at Least Grade II Acute Graft-Versus-Host Disease (GvHD)
To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone marrow allograft recipients who have at least Grade II GvHD.
Read the detailed description
This is a Phase I, open-label dose escalation trial of MEDI-507 in pediatric SCT and BMT recipients with at least Grade II acute GvHD. All patients will receive steroid therapy and MEDI-507 for treatment of GvHD
- Conditions
- Graft Versus Host Disease
- Being tested
- MEDI-507
- Keywords
- Acute GvHD of at least Grade II severity
- 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 given intravenously on Study Days 0, 3, 6 and 9
MEDI-507Drug
0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9
MEDI-507Drug
0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
| 2 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
| 3 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment of escalating dose levels of MEDI-507 in pediatric stell scell (SCT) and bone marrow (BMT) allograft recipients who have at least Grade II Graft-versus-Host Disease (GvHD).
Measured: Through Study Day 44
Secondary outcomes (1)
Evaluate the serum concentrations and pharmacokinetics (PK) of MEDI 507 and pharmacodynamic effects of MEDI-507 on the absolute lymphocyte count and dynamics of lymphocyte phenotypes.
Measured: Through Study Day 364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startSep 1999
- Primary completionJun 2004
- Study completionAug 2004
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813618
- Sponsor's protocol ID
- MI-CP049
- Acronym
- Pediatric GvHD
- Status last verified
- Dec 2008
- First submitted
- 19 Dec 2008
- Last updated
- 23 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of MEDI 507 in the Treatment of Pediatric Patients With at Least Grade II Acute Graft-Versus-Host Disease (GvHD)
- ClinicalTrials.gov ID
- NCT00813618
- Acronym / sponsor ID
- Pediatric GvHD / MI-CP049
- Conditions
- Graft Versus Host Disease
- Keywords
- Acute GvHD of at least Grade II severity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 1999
- Primary completion
- Jun 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 23 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.
To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone marrow allograft recipients who have at least Grade II GvHD.
Detailed description
This is a Phase I, open-label dose escalation trial of MEDI-507 in pediatric SCT and BMT recipients with at least Grade II acute GvHD. All patients will receive steroid therapy and MEDI-507 for treatment of GvHD
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-507MEDI-507 |
| 2 | Experimental | Drug: MEDI-507MEDI-507 |
| 3 | Experimental | Drug: MEDI-507MEDI-507 |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Allogeneic BMT or SCT recipients
- Acute GvHD of at least Grade II severity
- Age 2 to 17 years
- Evidence of engraftment (ANC over 500 cells/mm3 on two consecutive days within seven days before study entry)
- Receipt of GvHD prophylaxis regimen including methotrexate, tacrolimus or cyclosporine
Key exclusion criteria (15 listed)
- Treatment of acute GvHD with methylprednisolone (or equivalent corticosteroid) at a total dose exceeding 14 mg/kg (or equivalent) over a seven day period (for example, 2 mg/kg/day for seven days)
- Previous receipt of MEDI 507
- Previous treatment with any anti-T cell monoclonal antibodies, such as OKT3, daclizumab (Zenapax), or basiliximab (Simulect)
- Treatment with anti-thymocyte globulin (ATG, ATGAM or others) within 14 days
- More than one allogeneic bone marrow or hematopoietic stem cell allograft
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 given intravenously on Study Days 0, 3, 6 and 9 | Drug | 1 |
| MEDI-5070.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9 | Drug | 2 |
| MEDI-5070.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9 | Drug | 3 |
Primary outcome
Safety assessment of escalating dose levels of MEDI-507 in pediatric stell scell (SCT) and bone marrow (BMT) allograft recipients who have at least Grade II Graft-versus-Host Disease (GvHD).
Time frame: Through Study Day 44
1 secondary outcome
Evaluate the serum concentrations and pharmacokinetics (PK) of MEDI 507 and pharmacodynamic effects of MEDI-507 on the absolute lymphocyte count and dynamics of lymphocyte phenotypes.
Time frame: Through Study Day 364
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 23 Dec 2008.
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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 6 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 7 inclusion and 15 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 23 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 6 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 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 assessment of escalating dose levels of MEDI-507 in pediatric stell scell (SCT) and bone marrow (BMT) allograft recipients who have at least Grade II Graft-versus-Host Disease (GvHD). (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 23 Dec 2008.