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

NCT ID: NCT00338494

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2011-04-30

Brief 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.

Conditions

B-Cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Clofarabine

Intervention Type: DRUG

The starting dose of clofarabine will be 10 mg/m2 once a week for 3 weeks repeated every 4 weeks with dose escalations to 15, 20 , 30 and 40 mg/m2/week.

Interventions

Clofarabine

The starting dose of clofarabine will be 10 mg/m2 once a week for 3 weeks repeated every 4 weeks with dose escalations to 15, 20 , 30 and 40 mg/m2/week.

Intervention Type: DRUG

Other Intervention Names

CAFdA; Cl-F-ara-A

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francine Foss, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Comprehensive Cancer Center at Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0506000158

Identifier Type: -

Identifier Source: org_study_id