Study Stopped
slow accrual
Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil
The Treatment of Hematologic Malignancies With Single or Double Umbilical Cord Blood Unit Transplantation Followed by Graft-versus-Host Prophylaxis With Tacrolimus and Mycophenolate Mofetil
2 other identifiers
interventional
6
1 country
4
Brief Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: To look at the ability of umbilical cord blood cells from one or two unrelated donors to serve as a source of stem cells for people needing a bone marrow transplant.
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 Sep 2005
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedResults Posted
Study results publicly available
November 10, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 20, 2014
May 1, 2012
2.5 years
January 31, 2008
October 11, 2010
May 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With 100-day Non-relapse Mortality
Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).
100 days
Secondary Outcomes (6)
Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells
42 days
Number of Participants With Acute Graft-versus-host Disease (GVHD)
100 days
Number of Participants Who Relapsed at 1 Year
1 year
Number of Subjects With All-cause Mortality
at 100 days
Overall Survival
1 year
- +1 more secondary outcomes
Study Arms (3)
Pediatric Myeloablative conditioning
EXPERIMENTALPatients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide IV over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Adult Myeloablative conditioning
EXPERIMENTALPatients receive fludarabine phosphate IV over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Reduced-intensity conditioning
EXPERIMENTALPatients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Interventions
Given IV
Given IV
Given daily for 1-4 days
Eligibility Criteria
You may qualify if:
- Only one of the following should be present:
- Acute leukemia (lymphocytic or myeloid or undifferentiated or biphenotypic) in complete remission 2 or beyond
- Acute lymphocytic leukemia, Philadelphia chromosome positive in complete remission 1 or beyond
- Acute myeloid leukemia in complete remission 1 if it has evolved from a myeloproliferative disorder (MPD) or myelodysplastic syndrome (MDS).
- Acute leukemia in complete remission 1 if there is a failure to recover normal blood counts or the development of MDS following induction chemotherapy.
- Therapy related acute leukemia in complete remission 1 or beyond
- Chronic myeloid leukemia (CML) chronic phase-1 (imatinib failures, imatinib intolerance), or any CML beyond first chronic phase
- Myelodysplastic syndromes (Intermediate -1 or higher risk by IPSS)
- Therapy related MDS (irrespective of IPSS)
- Multiple myeloma must have had prior chemotherapy or autologous transplant
- Chronic lymphocytic leukemia must have failed two lines of conventional therapy but still chemosensitive to third line therapy.
- Chemosensitive Non-Hodgkin's lymphoma or Hodgkin's lymphoma in CR or PR after failing induction therapy.
- High risk acute leukemia/lymphoma eg Nk/T cell, HTLV associated leukemia/lymphoma, other T cell lymphoma/leukemia in first best response
- For patients with acute leukemia-they must be in a remission (less than 5% leukemic marrow blasts) at time of study entry.
- Karnofsky score of \> 70%
- +19 more criteria
You may not qualify if:
- Organ dysfunction as per standard guidelines. Unable to give informed consent (for adults only)
- Pregnant or lactating
- Sexually active individuals capable of becoming pregnant or causing a pregnancy who are unable or unwilling to use appropriate contraceptives.
- Active use of illicit drugs as evidenced by a positive toxicology screen for a substance not prescribed by a medical professional just prior to initiating the preparative regimen
- Actively smoking as evidenced by a positive nicotine screen just prior to initiating the preparative regimen
- HIV positive
- Patients with other unrelated malignancies will be excluded except:
- diagnosis of skin cancer (squamous cell or basal cell)
- diagnosis of cervical dysplasia (CIN I-III)
- any other malignancy which is currently in remission and was treated with curative intent more than 5 years preceding study entry
- In patients with secondary MDS or secondary acute leukemias-the previous non-hematopoietic neoplasm should be in remission but can be within 5 years of study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (4)
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37067-1631, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37067-5615, United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brian Engelhardt, M.D.
- Organization
- Vanderbilt-Ingram Cancer Center
Study Officials
- STUDY CHAIR
Brian Engelhardt, MD
Vanderbilt-Ingram Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine; Hematologist/Oncologist
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 6, 2008
Study Start
September 1, 2005
Primary Completion
March 1, 2008
Study Completion
May 1, 2011
Last Updated
May 20, 2014
Results First Posted
November 10, 2010
Record last verified: 2012-05