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Reduced Intensity Double Umbilical Cord Blood Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Karen Ballen, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01408563
First received: August 2, 2011
Last updated: September 15, 2014
Last verified: September 2014

August 2, 2011
September 15, 2014
September 2011
December 2015   (final data collection date for primary outcome measure)
One year significant viral infection rate [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
To determine the one year significant viral infection rate (viral infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation
Same as current
Complete list of historical versions of study NCT01408563 on ClinicalTrials.gov Archive Site
  • Time to neutrophil and platelet engraftment [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Rate of primary graft failure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Rates of Grade II-IV and Grade III-IV acute GVHD at 100 days [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • The rate of chronic GVHD [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • 100-day treatment related mortality [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • Immune reconstitution - CD4 count at 12 months [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Relapse-free and overall survival at 1 and 2 years from transplantation [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Relapse rate [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Rate of post-transplant lymphoma [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Thrombopoietin levels after transplant [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    Optional correlate
Same as current
Not Provided
Not Provided
 
Reduced Intensity Double Umbilical Cord Blood Transplantation
A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation

This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells.

Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.

Subjects will receive their transplants as in-patients.

  • IV-Catheter

    • one or two IV catheters will be placed on the day of hospital admission
  • Conditioning

    • Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)
    • Melphalan IV (day -1)
    • Total body radiation on day 0 (same day as transplant)
  • Immunosuppressive Therapy

    • Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. Given IV as in-patient, orally as out-patient
  • Infusion of Cord Blood units

    • 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Multiple Myeloma
  • Chronic Lymphocytic Leukemia
  • Acute Myelogenous Leukemia
  • Drug: Fludarabine
    30 mg/m2/day IV x 6 days
    Other Name: Fludara
  • Drug: Melphalan
    100 mg/m2/day IV x 1 day
  • Radiation: Total Body Radiation
    200 cGy on Day 0
  • Biological: Cord Blood
    2 cord blood units IV
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
April 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
  • Appropriate candidate for reduced intensity regimen, according to the treating physician
  • Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
  • Able to comply with the requirements for care after allogeneic stem cell transplantation

Exclusion Criteria:

  • Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
  • Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
  • Renal disease
  • Hepatic disease
  • Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
  • HIV-positive
  • Uncontrolled infection
  • Pregnant or breast-feeding
Both
18 Years to 70 Years
No
Contact: Karen Ballen, MD 617-724-1121 kballen@partners.org
United States
 
NCT01408563
11-085
Yes
Karen Ballen, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Karen Ballen, MD Massachusetts General Hospital
Massachusetts General Hospital
September 2014

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