Phase I Study of Sequential Cord Blood Transplants

This study has been completed.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Karen Ballen, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00299767
First received: March 3, 2006
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.


Condition Intervention Phase
Lymphoma
Leukemia
Multiple Myeloma
Myelodysplastic Syndrome
Procedure: sequential cord blood transplantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Sequential Cord Blood Transplants

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the 6 month transplant related (non-relapse) mortality. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate the days to neutrophil engraftment (ANC > 500). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate the days of platelet engraftment (platelet count > 20K unsupported). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate the risk of acute and chronic graft versus host disease. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To evaluate percent donor chimerism - contribution of each cord unit. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate relapse rate. [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • To evaluate overall survival. [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • To evaluate transfusion support needed to cord blood transplant recipients. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: May 2003
Study Completion Date: May 2009
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: sequential cord blood transplantation
    Infused on Day 0
Detailed Description:

Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil starting on day 0. Sequential cord blood units will be infused on Day 0.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Disease Status: NHL, HD, or MM refractory to chemotherapy or relapsed; CLL Rai Stage III/IV, or lymphocyte doubling time of 6 months, or Stage I/II resistant to 2 chemotherapy regimens; AML or ALL in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
  • Estimated disease-free survival of less than one year
  • ECOG performance status of 0, 1, 2
  • Lack of 6/6 or 5/6 HLA matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
  • 4/6 or greater HLA A, B, CRB1 cord blood units with a combined nucleated cell dose from of > 3.7 x 10(7) NC/kg

Exclusion Criteria:

  • Cardiac disease: symptomatic congestive hearth failure or RVG or echocardiogram determined left ventricular ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertension
  • Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of < 50%
  • Renal disease: serum creatinine > 2.0 mg/dl
  • Hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's syndrome), SGPT or SGOT > 3 x normal
  • Neurologic disease: symptomatic leukoencephalopathy, active DNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
  • HIV antibody or Hepatitis B surface antigen positivity
  • Uncontrolled infection
  • Pregnancy or breast-feeding mother
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299767

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02116
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Karen Ballen, M.D. Massachusetts General Hospital, Harvard University
Principal Investigator: Joseph Antin, M.D. Dana Farber Cancer Institute, Harvard Univeristy
Principal Investigator: David Avigan, M.D. Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Karen Ballen, Director, Leukemia Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00299767     History of Changes
Other Study ID Numbers: 03-061
Study First Received: March 3, 2006
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on April 23, 2014