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

NCT00338494 | Completed Phase 1

• 1 other identifier: 0506000158
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• tolerated dose (MTD) of clofarabine

  at the completion of dose escalation

• characterize and quantify the toxicity profile associated with clofarabine

  upon completion of the study

• determine the overall response rate, plus partial response of clofarabine

  upon completion of the study

Study Arms (1)

1

EXPERIMENTAL

Drug: Clofarabine

Interventions

Clofarabine 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.

Also known as: CAFdA, Cl-F-ara-A

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Yale Comprehensive Cancer Center at Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides

Study Officials

• Francine Foss, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2006
• First Posted: June 20, 2006
• Study Start: October 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2011
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

US (1)