LymphomaPhase 2NCT00081068
Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
A Phase 2 study testing alemtuzumab in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 15 sites in 5 countries.
Trial summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- alemtuzumab
- How many people
- 0 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Jan 2004to not given
- Phase
- Phase 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
DISEASE CHARACTERISTICS:
- Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)
- Immunoglobulin (Ig) M, IgG, and IgA paraprotein
- Measurable monoclonal paraprotein
- Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)
- CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- Absolute neutrophil count ≥ 500/mm^3
- Platelet count ≥ 25,000/mm^3
Hepatic
- SGOT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
Renal
- Creatinine ≤ 2.5 mg/dL (> 2.5 mg/dL allowed if due to disease)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception during and for 6 months after study participation
- No serious comorbid disease
- No uncontrolled bacterial, fungal, or viral infection
- No other active malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior alemtuzumab
- More than 3 months since other prior monoclonal antibody therapy
Chemotherapy
- See Disease Characteristics
- More than 21 days since prior chemotherapy
Endocrine therapy
- More than 21 days since prior steroid therapy
Radiotherapy
- More than 21 days since prior radiotherapy
Surgery
- Not specified
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States10 sites
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Rocky Mountain Cancer Centers - Denver Midtown
Denver, Colorado, 80218
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
Canada2 sites
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, ON L8N 3Z5
Princess Margaret Hospital
Toronto, Ontario, M5G 2C1
Australia1 site
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
United Kingdom1 site
Saint Bartholomew's Hospital
London, England, EC1A 7BE
About this study
Official title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.
Read the detailed description
OBJECTIVES:
- Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab.
- Determine the time to treatment failure in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12.
Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- alemtuzumab
- Keywords
- Waldenström macroglobulinemia
- Medical subject headings
- Lymphoma, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alemtuzumabBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response
Time to treatment failure
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jennifer Gansert, MD, PhD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081068
- Sponsor's protocol ID
- CDR0000358811
- Other IDs
- UCLA-0309058
- Status last verified
- Jan 2013
- First submitted
- 7 Apr 2004
- Last updated
- 8 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
- ClinicalTrials.gov ID
- NCT00081068
- Acronym / sponsor ID
- CDR0000358811
- Conditions
- Lymphoma
- Keywords
- Waldenström macroglobulinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2004
- First posted
- 8 Apr 2004 (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.
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.
Detailed description
OBJECTIVES:
- Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab.
- Determine the time to treatment failure in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12.
Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| alemtuzumab | Biological | – |
Primary outcome
Objective response
Time to treatment failure
Toxicity
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 8 Jan 2013.
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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.
Jennifer Gansert, MD, PhD study chair
Jonsson Comprehensive Cancer Center
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alemtuzumab in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada, Australia, France, United Kingdom. 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 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 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?
Objective response. The study lists 3 primary outcomes in all. 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 8 Jan 2013.