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

Brief Title

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

Official Title

Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermed.Grade B-Cell/T-Cell Lymphoma

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

tolerated dose (MTD) of clofarabine

Condition

B-Cell Lymphoma

Intervention

Clofarabine

Study Arms / Comparison Groups

 1

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

16

Start Date

October 2005

Completion Date

April 2011

Primary Completion Date

March 2010

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Francine Foss, M.D., , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00338494

Organization ID

0506000158

Responsible Party

Sponsor

Study Sponsor

Yale University

Collaborators

 Genzyme, a Sanofi Company

Study Sponsor

Francine Foss, M.D., Principal Investigator, Yale University

Verification Date

January 2015