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| Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00021151 |
Purpose
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Compassionate use refers to providing a drug to a patient on humanitarian grounds before the drug has received official approval.
PURPOSE: Compassionate use of Campath-1H in treating patients who have refractory prolymphocytic leukemia or chronic lymphocytic leukemia.
| Condition | Intervention |
|---|---|
|
Leukemia |
Drug: alemtuzumab |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | CAMPATH-1H Compassionate Treatment In Patients With PLL Who Have Failed At Least One Prior Regimen And CLL Patients Who Have Failed Fludarabine Therapy |
| Study Start Date: | January 2000 |
OBJECTIVES: I. Expand access to Campath-1H for patients with refractory prolymphocytic leukemia or chronic lymphocytic leukemia.
OUTLINE: Patients receive Campath-1H IV over 2 hours on days 1, 3, and 5. Treatment repeats weekly for 4-12 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Not specified
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Confirmed prolymphocytic leukemia (PLL) or chronic lymphocytic leukemia (CLL) PLL that has failed at least 1 prior regimen CLL that has failed prior fludarabine, defined as: No response Disease progression while receiving therapy OR Relapse within 6 months of completion of last dose
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (unless secondary to direct liver infiltration with CLL) Renal: Creatinine no greater than 2 times ULN Other: HIV negative No active infection No other severe concurrent disease No mental disorders No prior allergic reaction to rat or mouse-derived CDR-grafted humanized monoclonal antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified
Contacts and Locations More Information
| Study ID Numbers: | CDR0000068755, CWRU-ILEX-1999, ILEX-CAM511-A1, NCI-G01-1977 |
| Study First Received: | July 11, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00021151 |
| Health Authority: | United States: Federal Government |
|
refractory chronic lymphocytic leukemia prolymphocytic leukemia |
|
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, B-cell, chronic Fludarabine monophosphate Leukemia Lymphatic Diseases |
Leukemia, Prolymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Prolymphocytic leukemia Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders |
|
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
