Clofarabine and Rituximab in Treating Patients With Relapsed Non-Hodgkin Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade III lymphomatoid granulomatosis, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, cutaneous B-cell non-Hodgkin lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed B-cell lymphoma
- Relapsed disease
- CD20-positive disease
- Must have had bone marrow aspiration and biopsy (uni- or bilateral) within the past 42 days and chest CT and CT of the abdomen and pelvis within the past 28 days
Documented bidimensionally measurable disease within the past 28 days
- Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group(ECOG) performance status 0-2
- Leukocyte count ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelet count ≥ 75,000/μL
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy
- No known AIDS or HIV-associated complex
- No active hepatitis B infection
- No other severe concurrent disease, history of serious organ dysfunction, or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment
- No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment
- No history of intolerance or allergic reactions to clofarabine or rituximab
- No significant concurrent disease, illness, or psychiatric disorder that would compromise the patient's safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
- No concurrent active GI disease that may impair absorption of oral clofarabine
PRIOR CONCURRENT THERAPY:
- Recovered from all previous therapies
- No prior gastrointestinal (GI) surgery that may impair absorption of oral clofarabine
- More than 2 weeks since prior and no concurrent anticancer therapy, except for hydroxyurea
- More than 4 weeks since prior radioimmunotherapy
- More than 1 month since prior investigational agents
- No concurrent cytotoxic therapy or investigational therapy
- No other concurrent investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy
- No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes)
- No other concurrent chemotherapy or immunotherapy
- No concurrent radiotherapy
- No concurrent colony stimulating factors (phase I portion of the study)
Sites / Locations
- Knight Cancer Institute at Oregon Health and Science University
Arms of the Study
Arm 1
Experimental
Oral Clofarabine + Rituximab in Relapsed B Cell NHL
Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off). Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg Phase II: Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV