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Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease

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ClinicalTrials.gov Identifier: NCT00423826
Expanded Access Status : No longer available
First Posted : January 18, 2007
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Voravit Ratanatharathorn, Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date January 16, 2007
First Posted Date January 18, 2007
Last Update Posted Date February 29, 2016
 
Descriptive Information
Brief Title Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
Brief Summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before the transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well umbilical cord blood stem cell transplant works in treating patients with hematologic cancer or other disease.

Detailed Description

OBJECTIVES:

Primary

  • Determine the efficacy of double umbilical cord blood stem cell transplantation using a conditioning regimen comprising lower doses of busulfan and fludarabine phosphate and low-dose total body irradiation, in terms of stem cell engraftment at 60 days post transplantation, in patients with hematologic cancer or other diseases.
  • Determine the merits of conducting a larger, comparative study of this regimen.

Secondary

  • Determine mortality within 100 days of transplantation in these patients.

OUTLINE: This is a pilot study.

  • Reduced-intensity conditioning regimen: Patients receive busulfan IV over 3 hours on days -9 to -8 and fludarabine phosphate IV on days -7 to -3. Patients then undergo low-dose total body irradiation on day 0.
  • Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV twice daily and mycophenolate orally or IV three times daily beginning on day -3.
  • CNS prophylaxis and/or treatment: Patients with a history of CNS involvement receive prophylactic cytarabine (Ara-C) intrathecally (IT) prior to transplant. Patients also undergo lumbar puncture (LP) to test for active CNS disease. Patients with cerebrospinal fluid positive for leukemia receive Ara-C IT every 2-3 days until a repeat LP shows no remaining leukemic cells. Three days after the last LP and after one final dose of Ara-C, patients begin the conditioning regimen.
  • Double umbilical cord blood (UCB) donor stem cell transplantation (SCT): Patients undergo double UCB donor SCT on day 0.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Type Expanded Access
Intervention
  • Drug: Busulfan
    3 mg/kg intravenously over 3 hours
    Other Names:
    • Busulfex®
    • Myleran®
  • Drug: Cytarabine
    Patients with previous history of CNS involvement will receive pre-transplant intrathecal Cytarabine (Ara-C) (30 mg/M2) therapy.
    Other Names:
    • DepoCyt(TM)
    • Liposomal Ara-C
  • Drug: Fludarabine phosphate
    25 mg/M2/day IV
    Other Name: Fludara
  • Drug: mycophenolate mofetil
    Orally at the dose of 1 gm every 8 hours.
    Other Name: Cellcept
  • Drug: tacrolimus
    0.015 mg/kg IV every 12 hours by continuous infusion.
    Other Names:
    • Advagraf
    • Prograf
    • Protopic
  • Procedure: allogeneic hematopoietic stem cell transplantation
    10 days post drug intervention
  • Procedure: umbilical cord blood transplantation
    10 days post drug intervention
  • Radiation: total-body irradiation
    10 days post drug intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00423826
Responsible Party Voravit Ratanatharathorn, Barbara Ann Karmanos Cancer Institute
Study Sponsor Barbara Ann Karmanos Cancer Institute
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Voravit Ratanatharathorn, MD Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date February 2016