Non-Hodgkin's LymphomaPhase 1/2NCT00077961
Rituximab Plus CAMPATH in Patients With Relapsed/Refractory Low-Grade or Follicular, CD20-positive, B-cell NHL
A Phase 1/2 study testing CAMPATH (alemtuzumab) in people with Non-Hodgkin's Lymphoma, run by Genzyme, a Sanofi Company at 10 sites in United States.
Trial summary
The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- CAMPATH (alemtuzumab)
- How many people
- 49 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2003to Feb 2006
- 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
- For the Phase I portion of the study, patients must have pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma that has relapsed or is refractory. For the Phase II portion of the study, patients must have a pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma (Follicular, predominantly small cleaved or follicular, mixed small cleaved and large cell, International Working Formulation classification B or C or REAL classification follicular center grade 1,2) that has relapsed or is refractory.
- Previously treated with at least one anti-cancer regimen for NHL
- Measurable disease (lesions that can be accurately measured in 2 dimensions by CT scan with a greatest transverse diameter of >/= to 2cm or palpable lesions with both diameters of 2cm or more)
- Life expectancy of at least 12 weeks
- WHO performance status or 0 or 1
- Adequate marrow and organ function (as defined in the protocol)
- Completed major surgery, radiotherapy, chemotherapy, immunotherapy or biotherapy/targeted therapies at least 4 weeks prior to study entry (6 weeks if treated with a nitrosourea or mitomycin). Patients must have recovered from all prior treatment toxicity to Grade 1 or less, exclusive of alopecia.
Who cannot join
- Prior combination therapy with rituximab and CAMPATH; prior therapy with either agent alone is permitted
- A history of a T-cell lymphoma
- Known AIDS-related HIV-positive lymphoma
- For the Phase II portion of the study (once MTD has been determined), bulky disease, ie, any single mass >10cm or circulating malignant cells of 25,000/uL or more
- Prior autologous bone marrow or stem cell transplant within 6 months of study entry
- Prior allogeneic bone marrow transplant or organ transplant
Show all 16Show fewer
- Prior radiotherapy to the only site of measurable disease
- Medical condition requiring chronic use of oral, high-dose corticosteroids
- Use of investigational agents within 30 days of study enrollment
- Past history of anaphylaxis following exposure to humanized monoclonal antibodies
- Known, active, infection, including HIV positive
- Diagnosis of another malignancy within the previous five (5) years, unless the probability of recurrence of the prior malignancy is < 5%. Patients with curatively treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, cervical intraepithelial neoplasia (CIN), and patients with a history of malignant tumor in the past that have been disease-free for at least 5 years
- Active central nervous system (CNS) involvement with lymphoma
- Pregnant or nursing women
- Any significant concurrent disease or illness that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results
- Active hepatitis or a history of prior viral hepatitis B or C, or positive hepatitis B serologies without prior immunization
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Canton, Ohio, 44718
Study site
Cary, North Carolina, 27511
Study site
Colorado Springs, Colorado, 80909
Study site
Columbia, Missouri, 65201
Study site
Greenville, South Carolina, 29615
Study site
Lafayette, Louisiana, 70506
Study site
Manhasset, New York, 11030
Study site
New Orleans, Louisiana, 70115
Study site
Ocala, Florida, 34474
Study site
Park Ridge, Illinois, 60068
About this study
Official title: Phase I/II Study of Rituximab Plus CAMPATH in Patients With Previously Treated Relapsed or Refractory Low-Grade Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma
The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response.
Read the detailed description
This study is being conducted in 2 parts. Phase I will involve dose escalation of subcutaneous CAMPATH (SQ) given 3 times per week in combination with weekly doses of rituximab (375mg/m2) for a maximum of 8 weeks in order to determine the maximum tolerated dose (MTD). In Phase II patients will be treated with SQ CAMPATH at the MTD plus weekly rituximab (375mg/m2)for a maximum of 8 weeks with primary objective of defining Overall Response (OR) to this combination.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- CAMPATH (alemtuzumab)
- Keywords
- Non-Hodgkin's Lymphoma, NHL, CAMPATH, alemtuzumab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMPATH (alemtuzumab)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2004 (estimated)
- Study startDec 2003
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077961
- Sponsor's protocol ID
- CAM.NHL233
- Status last verified
- Mar 2015
- First submitted
- 13 Feb 2004
- Last updated
- 26 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Rituximab Plus CAMPATH in Patients With Previously Treated Relapsed or Refractory Low-Grade Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00077961
- Acronym / sponsor ID
- CAM.NHL233
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, NHL, CAMPATH, alemtuzumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 49 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Feb 2006 (actual)
- First posted
- 18 Feb 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.
The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response.
Detailed description
This study is being conducted in 2 parts. Phase I will involve dose escalation of subcutaneous CAMPATH (SQ) given 3 times per week in combination with weekly doses of rituximab (375mg/m2) for a maximum of 8 weeks in order to determine the maximum tolerated dose (MTD). In Phase II patients will be treated with SQ CAMPATH at the MTD plus weekly rituximab (375mg/m2)for a maximum of 8 weeks with primary objective of defining Overall Response (OR) to this combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For the Phase I portion of the study, patients must have pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma that has relapsed or is refractory. For the Phase II portion of the study, patients must have a pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma (Follicular, predominantly small cleaved or follicular, mixed small cleaved and large cell, International Working Formulation classification B or C or REAL classification follicular center grade 1,2) that has relapsed or is refractory.
- Previously treated with at least one anti-cancer regimen for NHL
- Measurable disease (lesions that can be accurately measured in 2 dimensions by CT scan with a greatest transverse diameter of >/= to 2cm or palpable lesions with both diameters of 2cm or more)
- Life expectancy of at least 12 weeks
- WHO performance status or 0 or 1
Key exclusion criteria (16 listed)
- Prior combination therapy with rituximab and CAMPATH; prior therapy with either agent alone is permitted
- A history of a T-cell lymphoma
- Known AIDS-related HIV-positive lymphoma
- For the Phase II portion of the study (once MTD has been determined), bulky disease, ie, any single mass >10cm or circulating malignant cells of 25,000/uL or more
- Prior autologous bone marrow or stem cell transplant within 6 months of study entry
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 (alemtuzumab) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
10 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 CAMPATH (alemtuzumab) in people with Non-Hodgkin's Lymphoma, run by Genzyme, a Sanofi Company at 10 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 was stopped early. Results are not available in the source record.
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.
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 26 Mar 2015.