Phase I Trial of Clofarabine in Combo w/ HD Etoposide & Cyclophosphamide and APBSCT for Pts w/ High-Risk or Refractory NHL

NCT00477945 | Completed Phase 1 DMC

• 1 other identifier: 0704-29 IUCRO-0187
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I trial to determine the maximum tolerated dose (MTD) of clofarabine in a combination with high-dose etoposide and cyclophosphamide. This is an initial step in developing a novel myeloablative preparative regimen for autologous hematopoietic stem cell transplantation (ASCT). While this phase I trial will initially develop the regimen in patients with refractory disease, it is expected that it will find its best application in patients with less advanced disease.

Conditions

Non Hodgkin's Lymphoma

Keywords

Non Hodgkin's Lymphoma; High Risk or Refractory Non Hodgkin's Lymphoma; APBSCT; clofarabine

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose (MTD) of clofarabine in association with high-dose etoposide and cyclophosphamide followed by ASCT in patients with refractory lymphoma malignancies.

  1 yr

Secondary Outcomes (1)

• Assessment of the toxicity of the combination of clofarabine, and high-dose etoposide and cyclophosphamide-- Describe engraftment kinetics-- Describe the response rate-- Describe relapse rate and event-free survival-- Assess clofarabine p

  1 year

Interventions

clofarabine DRUG

Cohort N Clofarabine (mg/m2/day) 1. 3-6 30 2. 3-6 40 3. 3-6 50 4. 3-6 60 5. 6-10 70

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documentation of disease. Patients must have one of the following disease types:
• Diffuse large cell non-Hodgkin's lymphoma, mediastinal B-cell lymphoma, or peripheral T-cell lymphoma that is:
• Primary refractory (achievement less than complete response)
• Relapsed and refractory (achievement less than a partial response) to at least a single salvage therapy
• Relapsed or primary refractory Follicular lymphoma (FL) with a high FL International Prognostic Index.
• Large cell transformation of lymphoma from a more indolent lymphoma (e.g., follicular, marginal zone, etc.)
• Mantle cell lymphoma that is:
• Primary Refractory (achievement less than complete response)
• Relapsed (regardless of chemosensitivity of relapsed disease)
• Patients who received prior autologous stem cell transplantation are not eligible.
• Patient age 18-70 years
• Performance status ECOG 0-1
• Required baseline laboratory values:
• LVEF \> 45% corrected
• DLCO \> 50% of predicted value (corrected for hemoglobin)

You may not qualify if:

• No active infection. Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
• No HIV disease. Patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies.
• Non-pregnant and non-nursing. Treatment under this protocol would expose a fetus to significant risks. Women of childbearing potential should have a negative pregnancy test prior to study entry. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus condom).

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

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

• Sherif Farag, MD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

US (1)