Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation

NCT00363467 | Terminated Results DMC

• 1 other identifier: MCC-14604
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

During the pre-transplantation phase (following completion of consolidation chemotherapy), patients will begin to receive G-CSF at 10 mcg/kg twice daily; leukapheresis will also be given until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. Conditioning/Preparative therapy will follow PBSC collection for up to 30 days with Busulfan IV daily x 4 days; subsequent doses will be adjusted based on pharmacokinetic (plasma level)monitoring. Following 1 day of rest, stem cell reinfusion will begin with supportive care. During follow-up, patients will be monitored out to 730 days.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Busulfan; Acute myeloid leukemia (AML); Hematopoietic Stem Cell Transplantation (HSCT); Dendritic cells; Bone marrow transplantation; PBSC mobilization; Autologous stem cells

Outcome Measures

Primary Outcomes (1)

• 100-day Non-relapse Mortality

  100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease

  100 days post transplant

Secondary Outcomes (4)

• Successful Autologous Stem Cell Collection

  At time of stem cell collection

• Severe Regimen-related Toxicity

  up to 100 days post translant

• 1 Year Event-free Survival

  1 year post transplant

• 1 Year Overall Survival

  1 year post transplant

Study Arms (1)

Autologous Hematopoietic Progenitor Cell Transplantation

OTHER

G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion

Drug: G-CSF; Drug: Leukapheresis; Drug: Busulfan; Procedure: Stem cell reinfusion

Interventions

G-CSF DRUG

Mobilization Option 1:Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously. Mobilization Option 2: If patients have recovered hematologically from consolidation chemotherapy, they may receive G-CSF at 10 mcg/kg twice daily subcutaneously.

Also known as: filgrastim or NeupogenR

Autologous Hematopoietic Progenitor Cell Transplantation

Leukapheresis DRUG

leukapheresis

Autologous Hematopoietic Progenitor Cell Transplantation

Busulfan DRUG

Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2

Also known as: Busulfan (MyleranR, Busulfex™)

Autologous Hematopoietic Progenitor Cell Transplantation

Stem cell reinfusion PROCEDURE

autologous stem cell transplant

Autologous Hematopoietic Progenitor Cell Transplantation

Eligibility Criteria

• Age: 56 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have had histologically confirmed diagnosis of AML, in 1st complete remission, by a pathologic review at the H. Lee Moffitt Cancer Center and Research Institute. Any induction/consolidation regimen is permitted.
• Age 56-74
• Able to give informed consent
• Hepatic and renal function: normal bilirubin, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal
• Left ventricular ejection fraction (LVEF) must be in normal range
• FEV1 AND DLCO greater than or equal to 50% predicted (at planned time of transplantation)
• ECOG PS less than or equal to 2 (at planned time of transplantation)
• Adverse-risk karyotype (del 5/5q, 7/7q, 3q, greater than or equal to 3 abnormalities):
• Intermediate-risk karyotype \[46 XY, +8, -Y, +6, or any other isolated (\<3 total) non-random abnormality not included in the adverse-risk category or favorable-risk category below\]
• AML arising from antecedent hematologic disorder (e.g. MDS)
• Secondary AML (t-AML)

You may not qualify if:

• Acute Promyelocytic Leukemia(FAB M3) subtype
• Presence of (8;21) translocation or inversion 16/t(16;16) cytogenetic phenotype (i.e. favorable-risk AML)
• Eligible for and willing to undergo matched-sibling allogeneic transplantation
• Greater than 2 induction regimens required to achieve complete remission
• Duration of \> 8 weeks between completion of induction chemotherapy and initiation of consolidation chemotherapy
• No prior malignancy is allowed, except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 5 years.
• Prior extensive radiation therapy (\>25% of bone marrow reserve)
• Concomitant radiation therapy, chemotherapy, or immunotherapy
• Intrinsic impaired organ function (as stated above)
• Active infection
• Positive serum pregnancy test in women who have not yet reached menopause (no menstrual periods for \>12 months or who have not undergone tubal ligation or complete hysterectomy.
• Women who are breast-feeding
• Positive HIV testing
• Presence of CNS leukemia
• Uncontrolled insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal gland dysfunction

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• ESP Pharma: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffiitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; Leukapheresis; Busulfan

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

Two patients enrolled and transplanted out of 24 targeted transplant accrual goal. Due to poor enrollment study closed and no further analyses were conducted.

Results Point of Contact

• Title: Jeffrey Lancet MD
• Organization: H. Lee Moffitt Cancer Center

Jeffrey.Lancet@moffitt.org

813-745-6841

Study Officials

• Jeffrey E Lancet, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: May 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 23, 2017
• Results First Posted: September 30, 2011

Record last verified: 2011-08

Locations

US (1)