Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.Phase 1MDX1411-02NCT00730652
Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
A Phase 1 study testing MDX-1411 in people with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma., run by Bristol-Myers Squibb.
Trial summary
To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.
- What is being tested?
- MDX-1411
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Mar 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of relapsed/refractory MCL or hematologically/bone marrow confirmed relapsed/refractory CLL that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy;
- Subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy
- For MCL, must have measurable disease
- At least 4 weeks since the last systemic therapy, including RT, for the treatment of MCL/CLL;
- At least 4 weeks since taking any corticosteroids prior to the first dose of MDX-1411
- ECOG Performance Status 0 to 2;
- No known positivity for human immunodeficiency virus (HIV) and no active infection with Hepatitis B or Hepatitis C;
Who cannot join
- History of severe hypersensitivity reactions to other monoclonal antibodies;
- Use of other investigational drugs within 30 days before study drug administration
- Prior treatment with any other anti-CD70 antibody;
- Active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of MDX-1411;
- Evidence of bleeding diathesis or coagulopathy;
- Active autoimmune disease requiring immunosuppressive therapy;
- Known current drug or alcohol abuse;
- Underlying medical conditions that will make the administration of MDX-1411 hazardous
About this study
Official title: A Phase I, Open-Label, Multicenter, Dose-escalation, Multidose Study of MDX-1411 Administered Every 7 Days in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma.
Read the detailed description
Dose-escalation, multidose study of MDX-1411, a fully human nonfucosylated monoclonal antibody (mAb) targeting the CD70 transmembrane cell-surface protein, which is highly expressed in B-cell malignancies such as CLL and MCL.
- Being tested
- MDX-1411
- Keywords
- Medarex Inc.
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX-1411Biological
Single dose of MDX-1411 (fully human monoclonal antibody) will be administered as an intravenous (i.v.) infusion every 7 days for up to a total of 5 doses.
| Study group | Role | What they receive |
|---|---|---|
| MDX1411 | Experimental | An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study. Receives: Biological: MDX-1411 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)
Measured: Day 1-40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMay 2009
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.Studies 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medarex Medical Monitor, Study director, Medarex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730652
- Sponsor's protocol ID
- MDX1411-02
- Acronym
- MDX1411-02
- Status last verified
- Apr 2010
- First submitted
- 4 Aug 2008
- Last updated
- 22 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multicenter, Dose-escalation, Multidose Study of MDX-1411 Administered Every 7 Days in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00730652
- Acronym / sponsor ID
- MDX1411-02 / MDX1411-02
- Keywords
- Medarex Inc.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 8 Aug 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 determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma.
Detailed description
Dose-escalation, multidose study of MDX-1411, a fully human nonfucosylated monoclonal antibody (mAb) targeting the CD70 transmembrane cell-surface protein, which is highly expressed in B-cell malignancies such as CLL and MCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDX1411 | Experimental | Biological: MDX-1411An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of relapsed/refractory MCL or hematologically/bone marrow confirmed relapsed/refractory CLL that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy;
- Subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy
- For MCL, must have measurable disease
- At least 4 weeks since the last systemic therapy, including RT, for the treatment of MCL/CLL;
- At least 4 weeks since taking any corticosteroids prior to the first dose of MDX-1411
Key exclusion criteria (8 listed)
- History of severe hypersensitivity reactions to other monoclonal antibodies;
- Use of other investigational drugs within 30 days before study drug administration
- Prior treatment with any other anti-CD70 antibody;
- Active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of MDX-1411;
- Evidence of bleeding diathesis or coagulopathy;
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-1411Single dose of MDX-1411 (fully human monoclonal antibody) will be administered as an intravenous (i.v.) infusion every 7 days for up to a total of 5 doses. | Biological | MDX1411 |
Primary outcome
Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)
Time frame: Day 1-40
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 22 Apr 2010.
Related trials for Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Active, not recruitingPhase 1/2
Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
RecruitingPhase 1/2
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma
RecruitingPhase 1/2
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
B-cell Acute Lymphoblastic Leukemia, Large B-cell 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.
Medarex Medical Monitor study director
Medarex
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MDX-1411 in people with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma., run by Bristol-Myers Squibb.
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 8 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 22 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD) (time frame: Day 1-40). 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 22 Apr 2010.