Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00514722
First received: August 8, 2007
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

This is a pilot study designed to evaluate the safety and feasibility of performing umbilical cord blood transplants in adults with high-risk hematopoietic malignancies. A novel myeloablative preparative regimen will be used. One, up to a maximum of three cord blood units will be administered to facilitate engraftment.


Condition Intervention
Acute Myeloid Leukemia
Myelodysplasia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Multiple Myeloma
Lymphoma, Large-Cell, Diffuse
Lymphoma, Mantle-Cell
Lymphoma, T-Cell, Peripheral
T-NK Cell Lymphoma
Hodgkin Disease
Other: umbilical cord stem cells

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • efficacy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • safety of umbilical cord transplant [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety of umbilical cord stem cell transplant [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: October 2002
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: umbilical cord stem cells
    umbilical cord stem cell allogeneic transplantation
Detailed Description:

This study intends to demonstrate an engraftment rate of >80% at day 100 post-transplantation and a transplant related mortality rate of < or equal to 50%. A TRM of >50% will be considered unacceptable. The present research will also:

  • Evaluate the toxicity of busulfan, fludarabine, and etoposide as preparative therapy prior to umbilical cord blood cell transplantation.
  • Evaluate neutrophil and platelet recovery following UCB transplantation.
  • Evaluate lineage-specific chimerism following transplantation and to assess the contribution of each individual CB unit to post-transplantation hematopoiesis.
  • Evaluate event free and overall survival.
  • Evaluate the incidence, severity and timing of acute and chronic GVHD following UCB transplantation.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age < or equal to 55
  • Availability of donor cord blood (one to three units) matching at least 4 of 6 HLA antigens (A, B, and DR). HLA class I antigens will be determined by serologic methods, and Class II antigens will be determined by high-resolution DNA typing. Typing will be confirmed by UCSF Immunogenetics Department following infusion. The UCB units must contain >2.5 x 10(7) TNC per kilogram recipient body weight. Cord blood units will be obtained from all available international banks.
  • HLA identical or 1 antigen mismatched related donors or potential HLA-matched unrelated donors (MUD) matching at >6/8 (A, B,C, DR) alleles must NOT be available.
  • Disease types:

    • Acute myeloid leukemia not expected to be curable with chemotherapy. This will include patients with high-risk cytogenetics (-7, -7q, -5, -5q, t(6,9), t(9,11), complex, Ph+), evolution from prior myelodysplasia or AML secondary to prior chemotherapy, failure to achieve remission, or second or subsequent remission. To ensure adequate time until disease progression, marrow blasts must be < or equal to 10%. This may be achieved using chemotherapy treatment.
    • Myelodysplasia with high-risk features. This will include patients with IPSS category INT2 or HI-risk MDS. Marrow blasts must be < or equal to 20%. If required, chemotherapy may be given to achieve target levels of blasts.
    • Acute lymphoblastic leukemia not expected to be curable with chemotherapy. This will include patients with high-risk cytogenetics (Ph+, t(4,11), 11q23 abnormalities, and monosomy 7), patients requiring more than one induction course to achieve remission, as well as patients failing to enter remission or in second or subsequent remission. To ensure adequate time until disease progression, marrow blasts must be < or equal to 10%. If required, chemotherapy may be given to achieve target levels of blasts.
    • Chronic myelogenous leukemia with advanced disease. This will include patients with accelerated or blastic phase or patients with chronic phase refractory to STI-5741. To ensure adequate time until disease progression, patients with blast crisis must show marrow blasts < or equal to 10%. If required, chemotherapy may be given to achieve target levels of blasts.
    • Multiple myeloma, stage II-III with >1st relapse or refractory disease or newly diagnosed with chromosome 13 abnormalities.
    • Lymphoma: diffuse large cell, mantle cell, peripheral T-cell, T-NK cell, or Hodgkin's disease which has failed to respond to primary therapy, progressed or recurred after prior therapy. Patients who have failed autologous transplant are eligible if they are >1 year post-transplant.
  • Patients must have an ECOG PS< or equal to 2
  • Laboratory requirements:
  • Creatinine <2.0mg/dL and creatinine clearance >40/m/min (calculated or based on 24 hour urine collection)
  • Bilirubin <2.0 mg/dL, AST/alkaline phosphatase <3x upper limit of normal
  • Patients with hepatitis C and active Hepatitis B are eligible only if a liver biopsy is performed and there is a < or equal to grade 2 inflammation or fibrosis.
  • Cardiac ejection fraction >40%
  • DLCO >40%
  • Negative pregnancy test (females of reproductive age)

Exclusion Criteria:

  • Active infection requiring ongoing antibiotic treatment
  • HIV infection
  • Poor performance status (ECOG >2)
  • Rapid progression of malignant disease
  • Opinion of BMT Committee that autologous transplant would be a preferable form of treatment
  • Organ function is below requirements
  • Pregnancy or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514722

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Thomas G. Martin, M.D. University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00514722     History of Changes
Other Study ID Numbers: UC2207
Study First Received: August 8, 2007
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Hematopoietic malignancies
Umbilical cord blood transplantation
Lymphoma: diffuse large cell, mantle cell, peripheral T-cell, T-NK cell, or Hodgkin's

Additional relevant MeSH terms:
Neoplasms
Hodgkin Disease
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Mantle-Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias

ClinicalTrials.gov processed this record on August 18, 2014