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Slow accrual.
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| Name | Class |
|---|---|
| Astex Pharmaceuticals, Inc. | INDUSTRY |
| Bayer | INDUSTRY |
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The goal of this clinical research study is to learn if giving pentostatin with alemtuzumab can help to control T-cell malignancy. The safety of this combination therapy will also be studied.
Alemtuzumab is an antibody protein that is directed towards a marker molecule on the surface of both B- and T- lymphoid cells. It is currently approved for use in treating patients with chronic lymphocytic leukemia and has been studied in treating patients with a number of T-cell malignancies. Alemtuzumab has been found to be effective in these conditions. Pentostatin is a drug that is approved for treating patients with hairy cell leukemia, a B-cell malignancy. Pentostatin has also been studied in a number of T-cell cancers and has been found to be effective. The purpose of this study is to see whether combining these drugs will prove to be more effective.
If you are found to be eligible to take part in this study, you will receive pentostatin through a central venous catheter in your vein once a week for 4 weeks and then every 2 weeks until the achievement of best response. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your physician will explain this procedure to you in more detail and you will be required to sign a separate consent form for this procedure.
Alemtuzumab will also be given through a vein catheter on Days 1, 2, and 3. The dose of alemtuzumab that you receive will be increased each day for the first 3 days to make sure that you tolerate it. It will then be given three times per week until you achieve the best response. If you develop reactions to alemtuzumab when given through a vein, you may receive it by injections of the same dose under the skin.
During the treatment, you will have blood (about 2 tablespoons) drawn once a week for the first 4 weeks for routine blood tests. These blood tests will then be repeated every 2 to 4 weeks for the remainder of the study. At the end of treatment a bone marrow examination will be repeated to document your response. Also, if you had a chest X-ray or CT scans, these will be repeated to confirm your level of response.
The maximum amount of time that alemtuzumab will be given is 3 months. The maximum amount of time that pentostatin will be given is 6 months. You may be able to receive the treatment will your local oncologists. However, you will have close follow-up at M. D. Anderson. You will be taken off this treatment if the disease gets worse during treatment or if unacceptable side effects develop.
You will be continued to be followed either directly or by telephone to evaluate your long-term response to treatment on this study.
This is an investigational study. Both alemtuzumab and pentostatin are commercially approved drugs that have been used to treat T-cell malignancies. A total of 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
This is an investigational study. Both alemtuzumab and pentostatin are commercially approved drugs that have been used to treat T-cell malignancies. A total of 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alemtuzumab + Pentostatin | Experimental | Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentostatin | Drug | 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Response | Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month. | After a maximum of 6 months of therapy maintained for one month. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farhad Ravandi-Kashani, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.T.M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M.D. Andersons website | View source |
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Of the 26 enrolled, only 24 patients were included in this study.
Recruitment Period: 8/241/2004 to 5/12/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alemtuzumab + Pentostatin | Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alemtuzumab + Pentostatin | Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| 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 | Number of Participants With Objective Response | Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month. | Analysis was per protocol. | Posted | Number | Participants | After a maximum of 6 months of therapy maintained for one month. |
|
5 years 2 months
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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 | Alemtuzumab + Pentostatin | Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated asparatate aminotransferase | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hives | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Farhad Ravandi-Kashani MD/Associate Professor | The University of Texas M D Anderson Cancer Center | 713-745-0394 | eharriso@mdanderson.org |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015649 | Pentostatin |
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D003070 | Coformycin |
| D005573 | Formycins |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Alemtuzumab | Drug | 30 mg IV three times weekly |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 15 |
| 24 |
| 23 |
| 24 |
| Bacteremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenic Fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Subdural Hematoma | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| sinusitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| non neutropenic fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| increased liver function | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Epididymitis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| viral infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| fatugue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hepatic | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ocular | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| tumor lysis syndrome | General disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |