A Phase I Trial of Myeloablative Conditioning w/ Clofarabine and HD Busulfan for Pts w/ Refractory Heme Malignancies Undergoing Allo PBSCT

NCT00477542 | Completed Phase 1 DMC

• 1 other identifier: 0704-30 IUCRO-0186
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase trial to determine the maximum tolerated dose (MTD) of clofarabine in a combination with a myeloablative dose of busulfan. This is an initial step in developing a novel myeloablative preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT). 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

Hematologic Malignancies

Keywords

Clofarabine; allogeneic HSCT; refractory malignancies

Outcome Measures

Primary Outcomes (1)

• Determine the MTD of clofarabine in association with a myeloablative dose of busulfan as a preparative regimen in patients with refractory hematological malignancies undergoing allogeneic HSCT.

  1 year

Secondary Outcomes (1)

• • Assessment of the toxicity of the combination of clofarabine and busulfan • Assess clofarabine and busulfan pharmacokinetics with combination therapy • Describe the response rate • Describe relapse rate and event-free survival

  1 year

Interventions

clofarabine DRUG

Cohort- n- Clofarabine (mg/m2/day) -1 3-10 20 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 - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Documentation of disease. Patients must have one of the following disease types:
• Acute myeloid leukemia (AML) with either:
• Primary refractory to induction chemotherapy
• Relapsed and refractory AML with \>5% blasts in bone marrow or extramedullary disease (excluding active disease of the central nervous system).
• Patients in second or subsequent complete remission (CR2, CR3, etc.).
• Acute lymphoblastic leukemia (ALL) with one of the following criteria:
• Primary refractory to induction chemotherapy.
• Relapsed and refractory ALL with \>5% blasts in bone marrow or extramedullary disease (excluding active disease of the central nervous system).
• Patients in second or subsequent complete remission (CR2, CR3, etc.).
• Myelodysplasia, refractory anemia with excess blasts with 11-20% blasts in the bone marrow (RAEB II).
• Chronic myelogenous leukemia (CML) with one of the following criteria:
• Accelerated phase.
• Patients in blast crisis.
• Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma, who also have one of the following criteria:
• Failure to achieve complete remission to primary induction therapy

You may not qualify if:

• Patients who relapse \< 6 months following autologous stem cell transplantation are not eligible

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

Hematologic Neoplasms; Neoplasms

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic 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 21, 2007
• First Posted: May 23, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

US (1)