Intervention: Clofarabine
Trial phase: Phase 1 | Phase 2
ATC code: L01BB06
SMILES: [H][C@]1(F)[C@H](O)[C@@H](CO)O[C@H]1n1cnc2c(N)nc(Cl)nc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 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
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)