Study Stopped
low accrual
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies
1 other identifier
interventional
4
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 8, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedAugust 14, 2013
August 1, 2013
6.4 years
August 8, 2007
August 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
efficacy
5 years
safety of umbilical cord transplant
5 years
Secondary Outcomes (1)
safety of umbilical cord stem cell transplant
5 years
Interventions
umbilical cord stem cell allogeneic transplantation
Eligibility Criteria
You may qualify if:
- 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.
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas G. Martin, M.D.
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2007
First Posted
August 10, 2007
Study Start
October 1, 2002
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 14, 2013
Record last verified: 2013-08