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Chronic Lymphocytic LeukemiaPhase 1MDX1342-02NCT00593944

Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)

A Phase 1 study testing MDX-1342 in people with Chronic Lymphocytic Leukemia, run by Bristol-Myers Squibb at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
MDX-1342
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesUnited States
Study dates
Aug 2008to May 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • relapsed/refractory CD19-positive CLL
  • At least 28 days since prior treatment for CLL
  • ECOG PS 0-2
  • Screening laboratory values must be met

Who cannot join

  • No prior anti-CD19 antibody tx
  • No active, uncontrolled infection
  • No prior allogeneic bone marrow transplant
  • No autoimmune disease

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Oncology Consultants, PA

    Houston, Texas, 77024

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia

The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.

Read the detailed description

Chronic lymphocytic leukemia (CLL) is a monoclonal hematopoietic disorder characterized by a progressive expansions of lymphocytes of B-cell lineage. These small, mature-appearing lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. CLL is a common leukemia in the wester world and accounts for 25% to 30% of adult leukemias. CD19,an integral membrane protein, is expressed by pro-B cells and functions as a co-stimulatory molecule that regulates mature B-cell activation and enhances B-cell proliferation. MDX-1342, a fully human monoclonal antibody, has demonstrated to specifically bind to human CD19 antigen with high affinity. Therefore, it is theorized that MDX-1342 will block activation of B cell stimulation, decreasing the number of cancerous B cell clones.

Being tested
MDX-1342
Keywords
CLL, Chronic Lymphocytic Leukemia, B cell, leukemia, lymphocyte, antibody, monoclonal, cancer, blood
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDX-1342Biological

    MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 40, 200, 1000, 2000 mg/dose.

Study groups in NCT00593944
Study groupRoleWhat they receive
1ExperimentalPatients will receive active MDX-1342.
Receives: Biological: MDX-1342

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence and severity of treatment-emergent adverse events

    Measured: all events will be followed to resolution

Secondary outcomes (6)

  1. response

    Measured: 12 weeks

  2. clinical laboratory tests

    Measured: study duratation - each visit

  3. physical examination

    Measured: study duration - each visit

  4. electrocardiogram

    Measured: at screening and study completion

  5. diagnostic testing

    Measured: at screening and study completion

  6. pharmacokinetics sampling

    Measured: at each dosing visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00593944
Sponsor's protocol ID
MDX1342-02
Other IDs
IM130-002
Acronym
MDX1342-02
Status last verified
May 2013
First submitted
3 Jan 2008
Last updated
22 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDX-1342 in people with Chronic Lymphocytic Leukemia, run by Bristol-Myers Squibb 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 4 inclusion and 4 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 22 May 2013. 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. 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?

incidence and severity of treatment-emergent adverse events (time frame: all events will be followed to resolution). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00593944.

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 May 2013.

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