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| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-31/98 | |||
| EU-98073 |
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RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy consisting of rituximab in treating patients with refractory or recurrent hairy cell leukemia following cladribine therapy.
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV over several hours once a week for 4 weeks.
Patients are followed every 3 months for 3 years and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 8-25 patients will be accrued for this study within 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological |
DISEASE CHARACTERISTICS:
Histologically proven hairy cell leukemia (HCL)
Classic HCL
Prolymphocytic HCL variant
Progressive or recurrent disease after prior treatment with cladribine
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Albert von Rohr, MD | Klinik Hirslanden, Zurich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Hirslanden | Zurich | CH-8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18603561 | Result | Zenhausern R, Simcock M, Gratwohl A, Hess U, Bargetzi M, Tobler A; Swiss Group for Clinical Cancer Research (SAKK). Rituximab in patients with hairy cell leukemia relapsing after treatment with 2-chlorodeoxyadenosine (SAKK 31/98). Haematologica. 2008 Sep;93(9):1426-8. doi: 10.3324/haematol.11564. Epub 2008 Jul 4. No abstract available. |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D007943 | Leukemia, Hairy Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |