Chronic Lymphocytic LymphomaPhase 1/2NCT00603668
Phase I/II Study of Different Doses and Dose Schedules of Milatuzumab (hLL1) in CLL
A Phase 1/2 study testing milatuzumab in people with Chronic Lymphocytic Lymphoma, run by Gilead Sciences at 5 sites in United States.
Trial summary
This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Lymphoma
- What is being tested?
- milatuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2008to Feb 2013
- Phase
- Phase 1/2
- 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 recurrent chronic lymphocytic leukemia (by NCI criteria)
- Received at least one prior treatment with standard therapy (previous antibody therapy is acceptable)
- Measurable disease (WBC > 5,000 for CLL)
- See protocol for full list
Who cannot join
- Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women
- Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion
- Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative;
- Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
- Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
- Known autoimmune disease or presence of autoimmune phenomena
Show all 9Show fewer
- At least 7 days beyond any infection requiring antibiotic use.
- Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, <20 mg/day, or equivalent) which may continue if unchanged.
- Substance abuse or other concurrent medical or psychiatric conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294
MD Anderson Cancer Center
Houston, Texas, 77030
M. D. Anderson Cancer Center
Orlando, Florida, 32806
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Georgetown University Hospital Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)
This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.
Read the detailed description
Milatuzumab (hLL1, IMMU-115), a humanized anti-CD74 monoclonal antibody. Dose escalation will utilize 4 planned dose regimens with 4.0 or 8.0 mg/kg doses administered intravenously either twice weekly (days 1 and 4) or thrice weekly (days 1, 3 and 5) for 4 consecutive weeks. The four planned dose regimens will be labeled as dose level 1 to 4 corresponding to increasing levels of the total dose of milatuzumab.
- Conditions
- Chronic Lymphocytic Lymphoma
- Being tested
- milatuzumab
- Keywords
- CLL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milatuzumabBiological
Also called IMMU-115, hLL1
two or three times a week dosing of hLL1 for a total of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| milatuzumab | Experimental | different doses of hLL1 Receives: Biological: milatuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events
Measured: over first 12 weeks
Secondary outcomes (5)
Efficacy (to see if the study drug works) in patients with NHL and CLL
Measured: over the first 12 weeks, then over up to 2 years
Pharmacokinetics (how the drug is processed by the body)
Measured: over the first 12 weeks
Pharmacodynamics (how the study drug is absorbed by the body)'
Measured: over the first 12 weeks, then over 2 years
Immunogenicity
Measured: over at least first 12 weeks
optimal dose
Measured: first 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LymphomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Wegener, MD, PhD, Study chair, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603668
- Sponsor's protocol ID
- IM-T-hLL1-02
- Status last verified
- Mar 2013
- First submitted
- 8 Jan 2008
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein R, Mattes MJ, Cardillo TM, Hansen HJ, Chang CH, Burton J, Govindan S, Goldenberg DM. CD74: a new candidate target for the immunotherapy of B-cell neoplasms. Clin Cancer Res. 2007 Sep 15;13(18 Pt 2):5556s-5563s. doi: 10.1158/1078-0432.CCR-07-1167.
PubMed 17875789Stein R, Qu Z, Cardillo TM, Chen S, Rosario A, Horak ID, Hansen HJ, Goldenberg DM. Antiproliferative activity of a humanized anti-CD74 monoclonal antibody, hLL1, on B-cell malignancies. Blood. 2004 Dec 1;104(12):3705-11. doi: 10.1182/blood-2004-03-0890. Epub 2004 Aug 5.
PubMed 15297317
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT00603668
- Acronym / sponsor ID
- IM-T-hLL1-02
- Conditions
- Chronic Lymphocytic Lymphoma
- Keywords
- CLL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 29 Jan 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.
This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.
Detailed description
Milatuzumab (hLL1, IMMU-115), a humanized anti-CD74 monoclonal antibody. Dose escalation will utilize 4 planned dose regimens with 4.0 or 8.0 mg/kg doses administered intravenously either twice weekly (days 1 and 4) or thrice weekly (days 1, 3 and 5) for 4 consecutive weeks. The four planned dose regimens will be labeled as dose level 1 to 4 corresponding to increasing levels of the total dose of milatuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| milatuzumab | Experimental | Biological: milatuzumabdifferent doses of hLL1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of recurrent chronic lymphocytic leukemia (by NCI criteria)
- Received at least one prior treatment with standard therapy (previous antibody therapy is acceptable)
- Measurable disease (WBC > 5,000 for CLL)
- See protocol for full list
Key exclusion criteria (9 listed)
- Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women
- Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion
- Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative;
- Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
- Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
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 |
|---|---|---|
| milatuzumabAlso: IMMU-115, hLL1two or three times a week dosing of hLL1 for a total of 4 weeks | Biological | milatuzumab |
Primary outcome
Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events
Time frame: over first 12 weeks
5 secondary outcomes
Efficacy (to see if the study drug works) in patients with NHL and CLL
Time frame: over the first 12 weeks, then over up to 2 years
Pharmacokinetics (how the drug is processed by the body)
Time frame: over the first 12 weeks
Pharmacodynamics (how the study drug is absorbed by the body)'
Time frame: over the first 12 weeks, then over 2 years
Immunogenicity
Time frame: over at least first 12 weeks
optimal dose
Time frame: first 12 weeks
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 16 Aug 2021.
- Background: PubMed 17875789Stein R, Mattes MJ, Cardillo TM, Hansen HJ, Chang CH, Burton J, Govindan S, Goldenberg DM. CD74: a new candidate target for the immunotherapy of B-cell neoplasms. Clin Cancer Res. 2007 Sep 15;13(18 Pt 2):5556s-5563s. doi: 10.1158/1078-0432.CCR-07-1167.
- Background: PubMed 15297317Stein R, Qu Z, Cardillo TM, Chen S, Rosario A, Horak ID, Hansen HJ, Goldenberg DM. Antiproliferative activity of a humanized anti-CD74 monoclonal antibody, hLL1, on B-cell malignancies. Blood. 2004 Dec 1;104(12):3705-11. doi: 10.1182/blood-2004-03-0890. Epub 2004 Aug 5.
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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.
William Wegener, MD, PhD study chair
Gilead Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing milatuzumab in people with Chronic Lymphocytic Lymphoma, run by Gilead Sciences at 5 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 9 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 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events (time frame: over first 12 weeks). 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 NCT00603668, which also lists 2 linked publications.
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 16 Aug 2021.