Chronic Lymphocytic LeukemiaNCT00587847
Campath Maintenance in Chronic Lymphocytic Leukemia
A study testing Campath in people with Chronic Lymphocytic Leukemia, run by Northwell Health at 1 site in United States.
Trial summary
This is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Campath
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Nov 2009
- Phase
- Interventional
- 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
- Enrollment in this study is open to patients 18 years of age with confirmed chronic lymphocytic leukemia, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2
Who cannot join
- Treatment failure in more than 3 prior regimens
- Active secondary malignancy
- Central nervous system involvement with CLL
- History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy
- History of HIV positivity
- Hepatitis C virus (HCV) positivity based upon core antigen testing
Show all 9Show fewer
- Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents
- Pregnancy or lactation
- Other severe, concurrent diseases or mental disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
About this study
Official title: Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia
This is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.
Read the detailed description
This is an open-label, single arm, proof-of-principle study of Campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. Patients achieving a presumptive complete response will receive no further treatment but will be followed for response. Non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. Responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. If remission has occurred, patients will be followed off treatment until documented disease progression.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Campath
- Keywords
- leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CampathDrug
Also called Alemtuzumab
Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
| Study group | Role | What they receive |
|---|---|---|
| Campath maintenance treatment | Other | Single arm, open label trial of Campath on a maintenance schedule for patients who have had a response to prior conventional chemotherapy. Treatments consist of dose escalation (3, 10 and 30mg) during week 1 followed by weekly dosing of Campath at 30 mg once weekly for 7 weeks followed by Campath 30 mg every 2 weeks for 16 weeks followed by Campath 30 mg once every 3 weeks for 24 weeks. Total duration of treatment up to 48 weeks. Receives: Drug: Campath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression (Months)
Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.
Measured: Every 8 weeks
Secondary outcomes (1)
Rate of Infections
Number of participants who developed clinical or laboratory evidence of infection.
Measured: Weekly then every 2 weeks then every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startAug 2005
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Insufficient recruitment.
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 Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Kanti Rai, MD, Northwell Health
- Investigators
- Kanti R. Rai, MD, Principal investigator, Long Island Jewish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587847
- Sponsor's protocol ID
- 05.10.030
- Other IDs
- Berlex Study# 106.0621
- Status last verified
- Sep 2015
- First submitted
- 21 Dec 2007
- Last updated
- 15 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00587847
- Acronym / sponsor ID
- 05.10.030
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- leukemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Aug 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Posted 15 Oct 2015
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 study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.
Detailed description
This is an open-label, single arm, proof-of-principle study of Campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. Patients achieving a presumptive complete response will receive no further treatment but will be followed for response. Non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. Responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. If remission has occurred, patients will be followed off treatment until documented disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Campath maintenance treatment | Other | Drug: CampathSingle arm, open label trial of Campath on a maintenance schedule for patients who have had a response to prior conventional chemotherapy. Treatments consist of dose escalation (3, 10 and 30mg) during week 1 followed by weekly dosing of Campath at 30 mg once weekly for 7 weeks followed by Campath 30 mg every 2 weeks for 16 weeks followed by Campath 30 mg once every 3 weeks for 24 weeks. Total duration of treatment up to 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrollment in this study is open to patients 18 years of age with confirmed chronic lymphocytic leukemia, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2
Key exclusion criteria (9 listed)
- Treatment failure in more than 3 prior regimens
- Active secondary malignancy
- Central nervous system involvement with CLL
- History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy
- History of HIV positivity
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 |
|---|---|---|
| CampathAlso: AlemtuzumabCampath 30 mg administered subcutaneously at varying intervals for up to 1 year | Drug | Campath maintenance treatment |
Primary outcome
Time to Progression (Months)
Time frame: Every 8 weeks
Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.
1 secondary outcome
Rate of Infections
Time frame: Weekly then every 2 weeks then every 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- 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.
Kanti R. Rai, MD principal investigator
Long Island Jewish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Campath in people with Chronic Lymphocytic Leukemia, run by Northwell Health at 1 site 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 1 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: stopped early, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2015). 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?
Time to Progression (Months) (time frame: Every 8 weeks). 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 15 Oct 2015.