Hodgkin's LymphomasPhase 1MDX1401-01NCT00634452
Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
A Phase 1 study testing MDX-1401 in people with Hodgkin's Lymphomas, run by Bristol-Myers Squibb at 6 sites in United States.
Trial summary
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hodgkin's Lymphomas
- What is being tested?
- MDX-1401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2008to Jan 2010
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
- Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
- Bi-measurable disease
- ECOG Performance Status of 0 - 2
- Meet all screening laboratory values
Who cannot join
- Previous treatment with any other anti-CD30 antibody
- History of allogeneic transplant
- Any tumor lesion greater than or equal to 10 cm in diameter
- Any active or chronic significant infection
- Underlying medical condition which will make the administration of MDX- 1401 hazardous
- Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
ClinWorks Cancer Research Center
Charlotte, North Carolina, 28207
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
West Virginia University
Morgantown, West Virginia, 26506
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Scott and White Memorial Hospital and Clinic
Temple, Texas, 76508
About this study
Official title: A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).
- Conditions
- Hodgkin's Lymphomas
- Being tested
- MDX-1401
- Keywords
- Hodgkin's, Cancer, bi-measurable disease, Lymphoma
- Medical subject headings
- Hodgkin Disease, Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX-1401Biological
IV weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| MDX-1401 | Experimental | MDX-1401 iv at various doses Receives: Biological: MDX-1401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Profile
Measured: Two years
Secondary outcomes (2)
Objective Response Rate (ORR)
Measured: Day 50
Tumor response assessment
Measured: Two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomasStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634452
- Sponsor's protocol ID
- MDX1401-01
- Other IDs
- CA213-001
- Acronym
- MDX1401-01
- Status last verified
- Dec 2012
- First submitted
- 26 Feb 2008
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00634452
- Acronym / sponsor ID
- MDX1401-01 / MDX1401-01
- Conditions
- Hodgkin's Lymphomas
- Keywords
- Hodgkin's, Cancer, bi-measurable disease, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Mar 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 establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDX-1401 | Experimental | Biological: MDX-1401MDX-1401 iv at various doses |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
- Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
- Bi-measurable disease
- ECOG Performance Status of 0 - 2
- Meet all screening laboratory values
Key exclusion criteria (6 listed)
- Previous treatment with any other anti-CD30 antibody
- History of allogeneic transplant
- Any tumor lesion greater than or equal to 10 cm in diameter
- Any active or chronic significant infection
- Underlying medical condition which will make the administration of MDX- 1401 hazardous
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 |
|---|---|---|
| MDX-1401IV weekly for 4 weeks | Biological | MDX-1401 |
Primary outcome
Safety and Tolerability Profile
Time frame: Two years
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: Day 50
Tumor response assessment
Time frame: Two year
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 6 Dec 2012.
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Non-Hodgkin Lymphoma
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 MDX-1401 in people with Hodgkin's Lymphomas, run by Bristol-Myers Squibb 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 5 inclusion and 6 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 6 Dec 2012. 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 and Tolerability Profile (time frame: Two years). 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 6 Dec 2012; AzTrials last refreshed its copy on 6 Nov 2026.