B-Cell Chronic Lymphocytic Leukemia (B-CLL)Phase 2NCT00328198
Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia
A Phase 2 study testing Alemtuzumab in people with B-Cell Chronic Lymphocytic Leukemia (B-CLL), run by Genzyme, a Sanofi Company at 21 sites in 6 countries.
Trial summary
This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for patients with relapsed or refractory B-CLL who have been previously treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Chronic Lymphocytic Leukemia (B-CLL)
- What is being tested?
- Alemtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 21 sitesin 6 countries
- Study dates
- May 2006to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- A diagnosis of B-cell chronic lymphocytic leukemia (B-CLL); according to the National Cancer Institute Working Group (NCI WG) Criteria.
- World Health Organization (WHO) performance status of 0, 1, or 2.
- Life expectancy ≥ 12 weeks.
- Previous therapy with at least one but no more than 5 regimens (single agent or combination regimen). One therapy regimen is defined as consecutive, contiguous cycles of the same drug(s) with no treatment interruptions lasting > 3 months.
- Patient requires treatment for CLL per the following criteria: -Rai stage III or IV; -Rai stage 0-II with at least one of the following - evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia; Massive (i.e. greater than 6 cm below the left costal margin) or progressive splenomegaly; Progressive lymphocytosis with an increase of greater than 50% over a 2-month period or an anticipated doubling time of less than 6 months; Lymphocyte count > 100*10^9/L; B symptoms.
- More than 3 weeks since prior chemotherapy. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
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- More than 3 weeks since using investigational agents. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
- Serum creatinine and conjugated (direct) bilirubin less than or equal to 2 times the institutional upper limit of normal (ULN) unless secondary to direct infiltration of the liver with CLL.
- Female patients with childbearing potential must have a negative pregnancy test (serum or urine) within 2 weeks of first dose of study drug(s). All patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months following study therapy.
- Signed, written informed consent (in the US, includes The Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization)
Who cannot join
- Positive Coombs test and evidence of active hemolysis.
- Platelet count less than 50*10^9/L without splenomegaly.
- History of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
- Previously treated with CAMPATH.
- Previous bone marrow transplant.
- Known central nervous system (CNS) involvement with B-CLL
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- Active infection, including human immunodeficiency virus (HIV) positive.
- Active second malignancy.
- Recent documented history (within 2 years) of active tuberculosis (TB), current active TB infection, currently receiving anti-tuberculous medication (e.g., INH, rifampin, streptomycin, pyrazinamide, or others).
- Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies. Patients with a positive hepatitis B surface antibody (HBsAb) test with a documented history of prior hepatitis B immunization are eligible as long as other criteria are met (i.e. negative tests for: hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) and hepatitis C virus antibody (HCVAb)).
- Other severe, concurrent diseases (e.g., cardiac or pulmonary disease), mental disorders, or major organ malfunction (liver, kidney) that could interfere with the patient ability to participate in the study.
- Pregnant or nursing women.
- Cytomegalovirus (CMV) positive by polymerase chain reaction (PCR) (above the level of detection). A patient that is PCR positive will require treatment to reduce the viral load to a non-detectable level; but such a patient may be considered for study entry once the infection has been treated.
- Medical condition requiring chronic use of oral corticosteroids at a dose higher than physiologic replacement.
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States7 sites
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80045
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80909
Mid Ohio Oncology Hematology, Inc.
Columbus, Ohio, 43213
Moores Cancer Center
La Jolla, California, 92093-0820
Wilshire Oncology Medical Group
La Verne, California, 91750
Joe Arrington Cancer Center
Lubbock, Texas, 79140
North Mississippi Hematology & Oncology Associates, Ltd.
Tupelo, Mississippi, 38801
Belgium4 sites
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, 1090
Cliniques Universitaires Saint-Luc
Brussels
Universitair Ziekenhuis Gent
Ghent, B-9000
Universitair Ziekenhuis Leuven
Leuven, B-3000
France3 sites
Hopital Hotel-Dieu
Clermont-Ferrand, 63058
Hopital Claude Huriez
Lille, 59037
Hopital Hotel-Dieu, CHU de Nantes-Service d'Hematologie Clinique
Nantes
United Kingdom3 sites
Leeds General Infirmary
Leeds, LS1 3EX
Royal Liverpool and Broadgreen Hospitals
Liverpool, L7 8XP
Nottingham City Hospital
Nottingham, NG5 1PB
Czechia2 sites
University Hospital Brno
Brno, 625 00
University Hospital Hradec Kralove (UH HK)
Hradec Králové
Serbia2 sites
Institute of Hematology, Clinical Centre of Serbia
Belgrade, 11 000
Clinic of Hematology, Clinical Centre Vojvodina Novi Sad
Novi Sad, 21000
About this study
Official title: A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia
This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for patients with relapsed or refractory B-CLL who have been previously treated.
- Being tested
- Alemtuzumab
- Keywords
- CAMPATH, Alemtuzumab, Leukemia, MabCampath, Chronic, Subcutaneous, CLL, C-CLL, Relapsed, Refractory, Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Bronchiolitis Obliterans Syndrome, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlemtuzumabBiological
Also called Campath®, MabCampath®
Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated). When escalation to 30 mg is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 18 weeks.
Part 1 of the study: The first 20 patients will be randomized to either Arm 1 (dose escalation) or Arm 2 (no escalation). Part 1 of the study has been completed; no additional patients will be enrolled in Part 1. An assigned review panel has reviewed the safety data from Part 1 and determined that all patients will be enrolled and treated under a no escalation schedule for Part 2 of the study.
AlemtuzumabBiological
Also called Campath®, MabCampath®
Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered SC at alternating injection sites 3 times per week for up to 18 weeks.
Part 2 of the study: All patients are currently being enrolled under the no escalation schedule for Part 2 of the study. All patients in Part 2 will be treated with 30mg of alemtuzumab (with no escalation period) administered SC (at alternating injection sites) 3 times per week (e.g., Monday, Wednesday, Friday) for up to 18 weeks. Alemtuzumab is to be administered in a supervised medical setting on an outpatient basis for the first three weeks, after which some study centers may allow a home administration option, with one weekly clinic visit. Under the home administration option, alemtuzumab may be administered by the patient or care giver if the patient meets conditions specified in the protocol guidelines for home administration.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated). Receives: Biological: Alemtuzumab |
| No escalation | Experimental | Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered subcutaneously at alternating injection sites 3 times per week for up to 18 weeks. Receives: Biological: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)
Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.
Measured: up to 44 weeks
Percentage of Participants Who Had an Overall Response (OR) as Determined by the Independent Response Review Panel (IRRP)
Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.
Measured: up to 44 weeks
Secondary outcomes (5)
Kaplan-Meier Estimates of Progression Free Survival as Determined by the Independent Response Review Panel (IRRP)
Progression-free survival was defined as the number of days from the date of first treatment to the date of first objective documentation of progressive disease (PD) as determined by the IRRP, or death due to any cause. Results are expressed in months.
Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology.
Measured: up to 5 years
Kaplan-Meier Estimates of Duration of Response as Determined by the Independent Response Review Panel (IRRP)
Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease (PD) as determined by IRRP or death due to any cause. Results are stated in months.
Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology.
Measured: up to 5 years
Kaplan-Meier Estimates of Overall Survival
Overall survival was defined as the time in days from the date of first treatment to the date of death due to any cause for all participants. Results are stated in months.
Measured: up to 5 years
Participants With a Minimal Residual Disease (MRD) Status of Negative
MRD negativity represents a very positive response outcome. MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. All patients are evaluated for treatment response based on National Cancer Institute Working Group (NCIWG) criteria. Of patients who have achieved a clinical complete response (CR) or partial response (PR) that met National Cancer Institute Working Group (NCIWG) criteria of CR except blood recovery, a bone marrow sample was taken for flow cytometry measure of MRD negativity.
Measured: 44 weeks
Participants With Treatment-Emergent Adverse Events (TEAE)
Number of participants with treatment-emergent adverse events (TEAEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (5 point scale from 'not related' to 'definitely related') and severity (5 point scale with grade 5 being most severe). Categories reported include participant counts for treatment-emergent AEs, injection site reactions, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), deaths and severity.
Measured: up to 18 weeks of treatment plus 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for B-Cell Chronic Lymphocytic Leukemia (B-CLL)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328198
- Sponsor's protocol ID
- CAM203
- Other IDs
- 2005-005074-69, 2005
- Status last verified
- Feb 2014
- First submitted
- 18 May 2006
- Last updated
- 13 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00328198
- Acronym / sponsor ID
- CAM203
- Keywords
- CAMPATH, Alemtuzumab, Leukemia, MabCampath, Chronic, Subcutaneous, CLL, C-CLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- May 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Posted 10 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for patients with relapsed or refractory B-CLL who have been previously treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Biological: AlemtuzumabAlemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated). |
| No escalation | Experimental | Biological: AlemtuzumabAlemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered subcutaneously at alternating injection sites 3 times per week for up to 18 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A diagnosis of B-cell chronic lymphocytic leukemia (B-CLL); according to the National Cancer Institute Working Group (NCI WG) Criteria.
- World Health Organization (WHO) performance status of 0, 1, or 2.
- Life expectancy ≥ 12 weeks.
- Previous therapy with at least one but no more than 5 regimens (single agent or combination regimen). One therapy regimen is defined as consecutive, contiguous cycles of the same drug(s) with no treatment interruptions lasting > 3 months.
- Patient requires treatment for CLL per the following criteria: -Rai stage III or IV; -Rai stage 0-II with at least one of the following - evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia; Massive (i.e. greater than 6 cm below the left costal margin) or progressive splenomegaly; Progressive lymphocytosis with an increase of greater than 50% over a 2-month period or an anticipated doubling time of less than 6 months; Lymphocyte count > 100*10^9/L; B symptoms.
Key exclusion criteria (14 listed)
- Positive Coombs test and evidence of active hemolysis.
- Platelet count less than 50*10^9/L without splenomegaly.
- History of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
- Previously treated with CAMPATH.
- Previous bone marrow transplant.
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 |
|---|---|---|
| AlemtuzumabAlso: Campath®, MabCampath®Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated). When escalation to 30 mg is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 18 weeks. Part 1 of the study: The first 20 patients will be randomized to either Arm 1 (dose escalation) or Arm 2 (no escalation). Part 1 of the study has been completed; no additional patients will be enrolled in Part 1. An assigned review panel has reviewed the safety data from Part 1 and determined that all patients will be enrolled and treated under a no escalation schedule for Part 2 of the study. | Biological | Dose escalation |
| AlemtuzumabAlso: Campath®, MabCampath®Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered SC at alternating injection sites 3 times per week for up to 18 weeks. Part 2 of the study: All patients are currently being enrolled under the no escalation schedule for Part 2 of the study. All patients in Part 2 will be treated with 30mg of alemtuzumab (with no escalation period) administered SC (at alternating injection sites) 3 times per week (e.g., Monday, Wednesday, Friday) for up to 18 weeks. Alemtuzumab is to be administered in a supervised medical setting on an outpatient basis for the first three weeks, after which some study centers may allow a home administration option, with one weekly clinic visit. Under the home administration option, alemtuzumab may be administered by the patient or care giver if the patient meets conditions specified in the protocol guidelines for home administration. | Biological | No escalation |
Primary outcome
Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)
Time frame: up to 44 weeks
Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.
Percentage of Participants Who Had an Overall Response (OR) as Determined by the Independent Response Review Panel (IRRP)
Time frame: up to 44 weeks
Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.
5 secondary outcomes
Kaplan-Meier Estimates of Progression Free Survival as Determined by the Independent Response Review Panel (IRRP)
Time frame: up to 5 years
Kaplan-Meier Estimates of Duration of Response as Determined by the Independent Response Review Panel (IRRP)
Time frame: up to 5 years
Kaplan-Meier Estimates of Overall Survival
Time frame: up to 5 years
Participants With a Minimal Residual Disease (MRD) Status of Negative
Time frame: 44 weeks
Participants With Treatment-Emergent Adverse Events (TEAE)
Time frame: up to 18 weeks of treatment plus 45 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
21 sites in 6 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 B-Cell Chronic Lymphocytic Leukemia (B-CLL), run by Genzyme, a Sanofi Company at 21 sites in 6 countries.
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 10 inclusion and 14 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 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Belgium, France, United Kingdom, Czechia and 1 more country. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP) (time frame: up to 44 weeks). The study lists 2 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 13 Mar 2014; AzTrials last refreshed its copy on 7 Nov 2026.