Study of Stem Cell Transplant for Leukemia and Myelodysplastic Syndromes Using Clofarabine and Busulfan Regimen

NCT00852163 | Completed Phase 2 DMC

• 1 other identifier: 006-150
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Clofarabine in combination with Busulfan is effective as a preparative transplant regimen for the treatment of leukemia and myelodysplastic syndromes

Conditions

Leukemia; Myelodysplastic Syndrome

Keywords

conditioning, preparative; clofarabine; transplant; Busulfan; leukemia; myelodysplastic syndrome

Outcome Measures

Primary Outcomes (1)

• Disease free survival at one and two year

  At 1 year and 2 Year

Secondary Outcomes (4)

• Incidence of hematopoietic engraftment

  100 days

• Incidence and severity of acute toxicities

  100 days

• Pharmacokinetic profiles of high dose busulfan and standard dose clofarabine

  Lesss than 8 days

• Acute GVHD

  100 Days

Study Arms (1)

Clofarabine with Busulfan

EXPERIMENTAL

Clofarabine 40 mg/m2 IV QD × 5 days Busulfan (Busulfex™) 3.2 mg/kg IV QD × 2 days

Drug: Clofarabine with Busulfan

Interventions

Clofarabine with Busulfan DRUG

Clofarabine 40 mg/m2 IV QD × 5 days Busulfan (Busulfex™) 3.2 mg/kg IV QD × 2 days

Also known as: Clofarabine:CLOLAR, clofarabine; CAFdA; Cl-F-ara-A;, Busulfan: Busulfex™

Clofarabine with Busulfan

Eligibility Criteria

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

You may qualify if:

• Disease Criteria:
• Acute myelogenous leukemia (AML)
• Acute lymphocytic leukemia (ALL)
• Myelodysplastic syndromes (MDS) Refractory anemia (RA) with adverse cytogenetics (SWOG criteria) or beyond (RAEB, RAEB-T, AML)
• Other Myeloproliferative Disorders Myelofibrosis, Agnogenic Myeloid Metaplasia, Chronic Myelomonocytic Leukemia (CMML)
• Chronic lymphocytic leukemia (CLL) High risk or advanced disease
• years of age or older
• Related or unrelated donor with HLA criteria as follows:
• Related donors: a serologic equivalent HLA Class I (A, B, and C) and Class II DRB1 or DQB1 matched donor OR a donor who is a single 1 antigen mismatched for A, B, C, DRB1, or DQB1 loci
• Unrelated donors: sequence-based typing fully matched A, B, C, DRB1, and DQB1 allele-matched donor OR a donor who is no greater than 1 antigen mismatched for A, B, C, DRB1, or DQB1 loci
• Able to provide valid informed consent.
• Female patients 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 up to 12 months after study treatment.

You may not qualify if:

• Organ Function Criteria:
• Cardiac: symptomatic coronary artery disease or ejection fraction \<45% or uncontrolled cardiac failure
• Pulmonary: FEV1 or DLCO (corrected) \<50% of predicted values and/or receiving continuous supplementary oxygen
• Hepatic: Bilirubin ≥ 1.2 mg/dL or AST/ALT ≥ 3x upper limit of normal (ULN) unless the liver is involved with malignant disease
• Renal: creatinine clearance \< 60 mL/min (24-hour urine collection) or \<50 mL/min (Glofil test)
• Karnofsky score \<60%
• Active CNS disease
• Prior hematopoietic transplantation (autologous or allogeneic) \<6 months prior to study entry
• Use of investigational agents less than or equal to 30 days before study entry.
• Life threatening, or clinically significant infection
• 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.
• Female patients who are pregnant or breast feeding
• HIV-positive

Sponsors & Collaborators

• Baylor Research Institute: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes

Interventions

Clofarabine; Busulfan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow 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; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Edward Agura, MD

  Baylor Health Care System

  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: February 25, 2009
• First Posted: February 26, 2009
• Study Start: March 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

US (1)