Alvocidib, Fludarabine Phosphate, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma
Completed · Phase 1
Conditions studied: B-cell Chronic Lymphocytic Leukemia, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Progressive Hairy Cell Leukemia, Initial Treatment, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Splenic Marginal Zone Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Small Lymphocytic Lymphoma, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma, Untreated Hairy Cell Leukemia, Waldenström Macroglobulinemia
In brief
This phase I trial studies the side effects, best way to give, and the best dose of alvocidib when given together with fludarabine phosphate and rituximab in treating patients with previously untreated or relapsed lymphoproliferative disorders or mantle cell lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as alvocidib and fludarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
Key facts
- Study ID
- NCT00058227
- Run by
- National Cancer Institute (NCI)
- People needed
- 37
- Starts
- 2003-04-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed mantle cell lymphoma OR indolent B-cell lymphoproliferative disorders of any of the following types:
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Follicular center cell non-Hodgkin's lymphoma (grade I or II)
- Marginal zone lymphoma
- Waldenstrom's macroglobulinemia
- Hairy cell leukemia
- Previously untreated or relapsed/refractory disease
- No evidence of histological transformation to an intermediate-grade or aggressive lymphoma
- CD20 positive by immunoperoxidase or flow cytometry
- Evaluable disease with presence of 1 of the following criteria:
- Absolute lymphocyte count greater than 5,000/mm\^3
- At least 1 measurable node greater than 2 cm by computed tomography (CT) scan OR measurable disease in a lymphoid structure (spleen)
- Bone marrow involvement (greater than 20% of marrow cellularity)
- Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
- See Disease Characteristics
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hemoglobin at least 9.0 g/dL
- Bilirubin no greater than 2 times normal
- Aspartate aminotransferase (AST) no greater than 2 times normal
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 50 mL/min
- No renal dysfunction that would impair tolerance or compliance with study therapy
- No cardiac dysfunction that would impair tolerance or compliance with study therapy
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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