Alvocidib, Fludarabine Phosphate, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma
B-cell Chronic Lymphocytic Leukemia, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma
About this trial
This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria: 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 No pulmonary dysfunction that would impair tolerance or compliance with study therapy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No chronic gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that would impair tolerability of compliance with therapy No neurological or psychiatric dysfunction that would impair tolerability of or compliance with study therapy At least 6 weeks since prior nitrosourea or mitomycin No more than 6 prior courses of fludarabine No concurrent corticosteroids as antiemetics At least 4 weeks since prior therapy for disease No more than 3 prior treatments for disease (not including steroids alone)
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (alvocidib, fludarabine phosphate, rituximab)
Patients receive fludarabine phosphate IV over 15-30 minutes on days 1-5 and rituximab IV over 3-4 hours on day 1. Alvocidib is administered IV over 60 minutes on day 1 in cohort 1; on days 1 and 2 in cohort 2; and on days 1, 2, and 3 in cohort 3. In cohorts 4 and 5, patients receive fludarabine phosphate and rituximab as above and alvocidib IV over 30 minutes and then IV over 4 hours on day 1 of courses 2-6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.