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| ID | Type | Description | Link |
|---|---|---|---|
| Berlex Study# 106.0621 | Other Identifier | Berlex |
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Insufficient recruitment.
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Campath | Drug | Campath 30 mg administered subcutaneously at varying intervals for up to 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Infections | Number of participants who developed clinical or laboratory evidence of infection. | Weekly then every 2 weeks then every 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kanti R. Rai, MD | Long Island Jewish Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm, Open Label Trial. | single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This was a pilot study with enrollment goal of 20 based on our patient population with potential to meet inclusion criteria. This goal was not met due to patient preferance for no further treatment which is standard of care.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm, Open Label Trial. | single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Full Range | months | Every 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm, Open Label Trial. | single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site reaction | General disorders | CTCAE (4.0) | Systematic Assessment | mild, grade 1 injection site reaction seen in 2 participants |
Trial was terminated early due to poor accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kanti Rai, MD | North Shore-Long Island Jewish Health System | (718) 470-4050 | krai@nshs.edu |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Rate of Infections | Number of participants who developed clinical or laboratory evidence of infection. | All participants who received at least one dose of alemtuzumab were analyzed for safety. | Posted | Number | participants | Weekly then every 2 weeks then every 3 weeks |
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Grade 2 pneumonia |
|
| Autoimmune disorder | Immune system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 Immune Thrombocytopenia (ITP) |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |