Text Size

Reduced Intensity Double Umbilical Cord Blood Transplantation

This study is currently recruiting participants.
Verified May 2013 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: May 22, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
Chronic Lymphocytic Leukemia
Acute Myelogenous Leukemia
 Drug: Fludarabine
Drug: Melphalan
Radiation: Total Body Radiation
Biological: Cord Blood
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 32
Study Start Date: September 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408563

Contacts
Contact: Karen Ballen, MD 617-724-1121 kballen@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Karen Ballen, MD            
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Corey Cutler, MD, MPH            
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: David Avigan, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Karen Ballen, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Karen Ballen, Director, Leukemia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01408563     History of Changes
Other Study ID Numbers: 11-085
Study First Received: August 2, 2011
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
NHL
lymphoma
leukemia
myelodysplastic disorder
aplastic anemia

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Leukemia, B-Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Melphalan
Fludarabine
Fludarabine monophosphate
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on June 18, 2013