Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Clofarabine is a new chemotherapy drug which was FDA approved for the treatment of acute lymphocytic leukemia in children. This study is being done to see if Clofarabine works in adult patients with B-cell types of lymphoma.

This research is being done to develop new treatments for patients with lymphoma whose cancer has returned or resisted treatment with previous chemotherapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Clofarabine

Criteria

Inclusion Criteria:

• Adult patients who are at least 18 years old

• Histologically confirmed low grade or intermediate-grade B-cell lymphoma

• Relapsed or refractory to at least one standard chemotherapy regimen. Patients who have received Rituximab alone without having received a cytotoxic agent are not eligible.

• Measurable disease, defined by the Cheson lymphoma criteria.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

• Life expectancy greater than 12 weeks

• Laboratory values obtained ≤2 weeks prior to entry

• Absolute neutrophil count (ANC) ≥ 1000 x 10 9/L

• White blood cell (WBC) count > 2.5 x 10 9/L

• Platelets ≥ 75 x 10 9/L

• Hemoglobin (Hg) > 9.0 g/dL

• Total bilirubin ≤2.0 mg/dL

• Aspartate transaminase (AST)/alanine transaminase (ALT) ≤3 × upper limit of normal (ULN)

• Serum creatinine ≤2.0 mg/dL

• Normal cardiac function, defined as an ejection fraction ≥45% determined by pretreatment radionuclide ventriculography (RVG) or echocardiogram.

• Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.

• Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.

• Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

Exclusion Criteria:

• Previously untreated B-cell lymphoma.

• Received previous treatment with clofarabine.

• Patients with known AIDS-related or HIV-positive lymphoma.

• Autologous bone marrow or stem cell transplant within 6 months of study entry.

• Prior radiotherapy to the only site of measurable disease.

• Any medical condition that requires chronic use of oral high-dose corticosteroids greater than 20 mg/day prednisone.

• Active autoimmune thrombocytopenia.

• Use of investigational agents within 30 days or any anticancer therapy within 3 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.

• Patients with an active, uncontrolled systemic infection considered to be opportunistic, life threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy).

• Active secondary malignancy.

• Pregnant or lactating patients.

• Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

• Patients with active or untreated central nervous system (CNS) lymphoma.