Chronic Lymphocytic Leukemia
Conditions
Keywords
leukemia
Brief 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.
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.
Interventions
DRUGCampath
Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
Sponsors
Bayer
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents * Pregnancy or lactation * Other severe, concurrent diseases or mental disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression (Months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Infections | Weekly then every 2 weeks then every 3 weeks | Number of participants who developed clinical or laboratory evidence of infection. |
Countries
United States
Participant flow
Recruitment details
The study was originally designed to recruit 20 patients but only 12 subjects were accrued to the trial before it was stopped due to poor recruitment. Subjects were entered between August 2005 and July 2007. All subjects had Chronic Lymphocytic Leukemia that was previously treated with chemotherapy.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm, Open Label Trial. single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 5 |
Baseline characteristics
| Characteristic | Single Arm, Open Label Trial. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: Every 8 weeks
Population: All patients who were entered on study were analyzed according to NCI Working Group Response Criteria for CLL. Adverse events were graded on a scale of 1 to 4, where possible, according to the NCI Common Toxicity Criteria, Version 2.0.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm, Open Label Trial. | Time to Progression (Months) | 10 months |
Secondary
Rate of Infections
Number of participants who developed clinical or laboratory evidence of infection.
Time frame: Weekly then every 2 weeks then every 3 weeks
Population: All participants who received at least one dose of alemtuzumab were analyzed for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm, Open Label Trial. | Rate of Infections | 2 participants |