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| ID | Type | Description | Link |
|---|---|---|---|
| NCCTG-988152 | |||
| CDR0000067843 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2012-02331 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia.
OBJECTIVES: I. Determine the rate and duration of complete and partial remission in patients with recurrent B-cell chronic lymphocytic leukemia treated with gemcitabine. II. Assess the toxicities of this regimen in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 4 weeks for a minimum of 3 courses. Patients achieving clinical complete remission, complete remission, nodular partial remission, or partial remission following 3 courses of therapy, receive 2 additional courses of therapy. Patients achieving complete remission or further improvement following the 2 additional courses of therapy, receive another 2 courses of therapy. Patients are followed every 3 months until disease progression or relapse. Patients achieving complete remission are followed every 6 months for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemcitabine | Experimental | Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 4 weeks for a minimum of 3 courses. Patients achieving clinical complete remission, complete remission, nodular partial remission, or partial remission following 3 courses of therapy, receive 2 additional courses of therapy. Patients achieving complete remission or further improvement following the 2 additional courses of therapy, receive another 2 courses of therapy. Patients are followed every 3 months until disease progression or relapse. Patients achieving complete remission are followed every 6 months for 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| confirmed response | Up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Up to 8 years | |
| progression free survival | Up to 8 years | |
| time to progression |
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DISEASE CHARACTERISTICS: Diagnosis of B-cell chronic lymphocytic leukemia manifested by all of the following: Minimum threshold peripheral lymphocyte count of at least 5,000/mm3 Small to medium sized peripheral blood lymphocytes with no greater than 55% prolymphocytes Bone marrow aspirate and biopsy containing at least 30% lymphoid cells Immunophenotypic and biopsy evaluation of peripheral blood lymphocytes demonstrating monoclonality of B lymphocytes B-cell markers with CD5 antigen (e.g., T-1, T-101) in the absence of other pan T-cell markers (e.g., CD3, CD2) Expression of CD19, CD20, and CD23 B cell surface markers B-cell expression of kappa or lambda light chains Active disease with at least one of the following criteria: One or more disease related symptoms: At least 10% weight loss within the past 6 months Fever greater than 100.5 F for at least 2 weeks without evidence of infection Night sweats without evidence of infection Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin less than 11.0 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm3) (i.e., any stage III or IV disease) Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy Massive (i.e., greater than 6 cm below the left costal margin) or progressive splenomegaly (i.e., a greater than 50% increase over two months) Massive (i.e., greater than 10 cm in longest diameter) or progressive lymphadenopathy (i.e., a greater than 50% increase over two months) Progressive lymphocytosis with an increase of greater than 50% over a 2 month period (unrelated to corticosteroids) or an anticipated doubling time of less than 6 months No marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any criteria for active disease Previously treated with at least a fludarabine or cladribine based regimen and a prior alkylating agent with evidence of recurrent or progressive disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN (unless due to hemolysis or chronic lymphocytic leukemia) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No myocardial infarction within the past month Other: No uncontrolled infection HIV negative No other active malignancy 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 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery
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| Name | Affiliation | Role |
|---|---|---|
| Timothy G. Call, MD | Mayo Clinic | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Call TG, Constantinou CL, Kahanic SP, et al.: NCCTG trial of gemcitabine for relapsed B-cell chronic lymphocytic leukemia. [Abstract] J Clin Oncol 22 (Suppl 14): A-6726, 613s, 2004. |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Up to 8 years |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |