A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkin's Lymphoma

NCT00201669 | Completed Phase 2 DMC

• 1 other identifier: OSU-0442
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the efficacy of clofarabine as measured by response rate in patients with aggressive non-Hodgkin's lymphoma

Conditions

Non-Hodgkin's Lymphoma

Keywords

Aggressive; Clofarabine

Outcome Measures

Primary Outcomes (1)

• Response rate

  up to two years

Secondary Outcomes (4)

• Determine the toxicity of clofarabine administered in conjunction with growth factor support in patients with relapsed/refractory aggressive NHL.

  up to two years

• determine the effect of clofarabine on T-, B-, and natural killer (NK)-cell subsets and quantitative immunoglobulin levels after prolonged administration of clofarabine in patients with NHL.

  up to two years

• Assess cytokine (tumor necrosis factor [TNF]-alpha, interleukin [IL]-6, and IL-10) release following clofarabine therapy.

  up to two years

• Assess the effect of pre-treatment prognostic factors (p53 mutational status, DNA methylation, and apoptotic protein levels) in patient-derived tumor tissue on response to clofarabine.

  up to two years

Study Arms (1)

Arm I

EXPERIMENTAL

Drug: Clofarabine

Interventions

Clofarabine DRUG

Clofarabine 30 mg/m2/day will be administered as a 2-hour intravenous infusion (IVI) on days 1-5.

Also known as: Clolar

Arm I

Eligibility Criteria

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

You may qualify if:

• Must have histologically confirmed aggressive NHL
• B-cell NHL must be relapsed/ refractory
• T-cell \& NK-cell and transformed lymphoma eligible at DX
• Patients with B-cell NHL (ie, diffuse large B-cell lymphoma, mantle cell lymphoma, and Burkitt's lymphoma) must have relapsed or refractory disease after at least 1 prior therapy.
• Patients previously treated with radioimmunotherapy (ie, ibritumomab tiuxetan \[Zevalin\] or tositumomab \[Bexxar\]) or prior stem cell transplant (SCT) are eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Life expectancy of at least 12 weeks.
• Laboratory values obtained ≤ 7 days prior to registration:
• Absolute neutrophil count (ANC) ≥ 1500/mm3
• Platelets ≥ 100,000/mm3
• Total bilirubin ≤ upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2 × ULN
• Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2 × ULN
• Serum creatinine ≤ ULN

You may not qualify if:

• No prior treatment with clofarabine.
• Full recovery from all acute toxicities associated with prior chemotherapy, radiotherapy, or immunotherapy.- Patients with 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) are not eligible.
• Cardiac function (i.e. left ventricular ejection fraction) ≥ 50% on pretreatment radionuclide ventriculography (RVG) or echocardiogram.
• Women that are pregnant or breastfeeding.
• Known HIV disease.
• No CNS lymphoma

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Aggression

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

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

• Kristie Blum

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: June 1, 2006
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (1)