Lymphoplasmacytic LymphomaPhase 2NCT00142181
Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia
A Phase 2 study testing Campath-1H in people with Lymphoplasmacytic Lymphoma and Waldenstrom's Macroglobulinemia, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphoplasmacytic Lymphoma, Waldenstrom's Macroglobulinemia
- What is being tested?
- Campath-1H
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2003to Jun 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia
- Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit.
- Age greater than 18 years
- Life expectancy of 6 months or greater
- ECOG performance status of 0-2
Who cannot join
- Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
- Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
- Pregnant women
- Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Isreal Deaconness Medical Center
Boston, Massachusetts, 02115
Dana-farber Cancer Insitiute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.
Read the detailed description
- Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient tolerates these three test doses, then they will receive a total of 6 weeks of Campath-1H therapy three times a week.
- After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing. If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H, the patient will be removed from the study.
- If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years.
- If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy. The patient will then be reassessed as described above.
- No additional therapy (as part of this study) will be performed after a 12 week course of Campath-1H.
- While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment. Bone marrow biopsies and/or aspirations will be conducted as necessary.
- Being tested
- Campath-1H
- Keywords
- Lymphoplasmacytic lymphoma, Waldenstrom's Macroglobulinemia, Antibody, Campath-1H
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Campath-1HDrug
Participant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Campath-1H | Experimental | 30 mg IV three times a week, 6-12 weeks. Receives: Drug: Campath-1H |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.
Measured: 2 years
Secondary outcomes (1)
To determine the safety of Campath-1H.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionOct 2005
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoplasmacytic LymphomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Bayer, University of California, Los Angeles, Northwestern University, Arizona Oncology Associates
- Responsible party
- Principal investigator, Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Steven P. Treon, MD, MA, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142181
- Sponsor's protocol ID
- 02-079
- Status last verified
- Dec 2012
- First submitted
- 1 Sep 2005
- Last updated
- 21 Dec 2012
- Results posted
- No
Publications
Treon SP, Soumerai JD, Hunter ZR, Patterson CJ, Ioakimidis L, Kahl B, Boxer M. Long-term follow-up of symptomatic patients with lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia treated with the anti-CD52 monoclonal antibody alemtuzumab. Blood. 2011 Jul 14;118(2):276-81. doi: 10.1182/blood-2011-02-338558. Epub 2011 May 12.
PubMed 21566092
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
- ClinicalTrials.gov ID
- NCT00142181
- Acronym / sponsor ID
- 02-079
- Keywords
- Lymphoplasmacytic lymphoma, Waldenstrom's Macroglobulinemia, Antibody, Campath-1H
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Bayer, University of California, Los Angeles, Northwestern University, Arizona Oncology Associates
- Study start
- Mar 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 2 Sep 2005 (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.
The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.
Detailed description
- Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient tolerates these three test doses, then they will receive a total of 6 weeks of Campath-1H therapy three times a week.
- After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing. If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H, the patient will be removed from the study.
- If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years.
- If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy. The patient will then be reassessed as described above.
- No additional therapy (as part of this study) will be performed after a 12 week course of Campath-1H.
- While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment. Bone marrow biopsies and/or aspirations will be conducted as necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Campath-1H | Experimental | Drug: Campath-1H30 mg IV three times a week, 6-12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia
- Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit.
- Age greater than 18 years
- Life expectancy of 6 months or greater
- ECOG performance status of 0-2
Key exclusion criteria (4 listed)
- Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
- Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
- Pregnant women
- Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.
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 |
|---|---|---|
| Campath-1HParticipant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks. | Drug | Campath-1H |
Primary outcome
To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.
Time frame: 2 years
1 secondary outcome
To determine the safety of Campath-1H.
Time frame: 2 years
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 21 Dec 2012.
- Results publication: PubMed 21566092Treon SP, Soumerai JD, Hunter ZR, Patterson CJ, Ioakimidis L, Kahl B, Boxer M. Long-term follow-up of symptomatic patients with lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia treated with the anti-CD52 monoclonal antibody alemtuzumab. Blood. 2011 Jul 14;118(2):276-81. doi: 10.1182/blood-2011-02-338558. Epub 2011 May 12.
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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.
Steven P. Treon, MD, MA, PhD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Campath-1H in people with Lymphoplasmacytic Lymphoma and Waldenstrom's Macroglobulinemia, run by Dana-Farber Cancer Institute 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 5 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 21 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 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 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?
To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia. (time frame: 2 years). 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 NCT00142181, which also lists 1 linked publication.
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 21 Dec 2012.