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Cord Blood Transplantation for Patients With Cancer

This study has been terminated.
(did not accrue enough patients.)
Sponsor:
Information provided by (Responsible Party):
Andrew Artz, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT01359254
First received: May 20, 2011
Last updated: July 8, 2012
Last verified: July 2012
History of Changes

May 20, 2011
July 8, 2012
April 2010
September 2011   (final data collection date for primary outcome measure)
Cord Blood Engraftment [ Time Frame: 100 days ] [ Designated as safety issue: No ]
Detectable cord blood engraftment should be present by day 100 in at least 50% of patients.
Same as current
Complete list of historical versions of study NCT01359254 on ClinicalTrials.gov Archive Site
Survival at Day 100 [ Time Frame: 100 days ] [ Designated as safety issue: No ]
Being alive 100 days after the stem cell infusion
Same as current
Not Provided
Not Provided
 
Cord Blood Transplantation for Patients With Cancer
Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies

To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hematological Disease
  • Drug: Melphalan, Fludarabine, and Antithymocyte Globulin (ATG)
    Fludarabine is given daily for 5 days. Melphalan is given daily for 2 days, overlapping with the completion of fludarabine. ATG is given every other day for 4 days.
  • Drug: Fludarabine, Busulfan, ATG, and Total Body Irradiation (TBI)
    Fludarabine is given through the vein daily for 5 days; Busulfan is given daily for 4 days; and ATG every other day for 4 days. TBI is given twice on the last day.
  • Experimental: Conditioning Regimen I
    Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
    Intervention: Drug: Melphalan, Fludarabine, and Antithymocyte Globulin (ATG)
  • Experimental: Conditioning Regimen II
    Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
    Intervention: Drug: Fludarabine, Busulfan, ATG, and Total Body Irradiation (TBI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
June 2012
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Relapsed or refractory acute leukemia (myeloid or lymphoid)
  • Acute leukemia in first remission at high-risk for recurrence
  • Chronic myelogenous leukemia in accelerated phase or blast-crisis
  • Chronic myelogenous leukemia in chronic phase
  • Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
  • Chronic lymphocytic leukemia, relapsed or with poor prognostic features
  • Multiple myeloma
  • Myelodysplastic syndrome
  • Chronic myeloproliferative disease
  • Hemoglobinopathies
  • Aplastic anemia

Exclusion Criteria:

  • Zubrod performance status > 2
  • Life expectancy is severely limited by concomitant illness
  • Patients with severely decreased LVEF or impaired pulmonary function tests
  • Estimated Creatinine Clearance <50 ml/min
  • Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal
  • Evidence of chronic active hepatitis or cirrhosis
  • HIV-positive
  • Patient is pregnant
  • Patient or guardian not able to sign informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01359254
10-020-B
No
Andrew Artz, MD, University of Chicago
University of Chicago
Not Provided
Principal Investigator: Andrew Artz, MD University of Chicago
University of Chicago
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP