Study Stopped
replaced by another study ; Trial re-written as MT2015-29
Stem Cell Transplant for Hematological Malignancy
Allogeneic Transplant for Hematological Malignancy
3 other identifiers
interventional
330
1 country
1
Brief Summary
The purpose of this study is to develop a standard of care treatment using allogeneic stem cells for patients with cancers of the blood. The protocol was revised to reflect that this study is considered "treatment guidelines", rather than a research study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2001
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedResults Posted
Study results publicly available
January 22, 2021
CompletedJanuary 22, 2021
December 1, 2020
18.2 years
September 12, 2005
December 30, 2020
December 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
2 years
Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant
Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
5 years
Secondary Outcomes (8)
Number of Participants With Neutrophil Engraftment
Day 42
Number of Participants With Acute Graft-versus-host Disease (GVHD)
Day 100
Number of Participants With Chronic Graft-Versus-Host Disease
1 year
Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant
2 years
Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant
5 years
- +3 more secondary outcomes
Study Arms (8)
PBSC: No TBI
EXPERIMENTALPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
Marrow : No TBI
EXPERIMENTALPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
UCB : No TBI
EXPERIMENTALPatients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
UCB : No TBI/Bu/Cy/ATG
EXPERIMENTALPatients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
PBSC
EXPERIMENTALPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
Marrow
EXPERIMENTALPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
UCB
EXPERIMENTALPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
Co-Enroll From MT0403
EXPERIMENTALPatients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
Interventions
Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
On Day -4, -3, -2, -1 total body irradiation is given twice daily.
When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
UCB recipients who have not had chemotherapy in the preceding 3 months will also receive Equine ATG (ATGAM) 15 mg/kg IV will be administered every 12 hours for 6 doses beginning on day -3 per institutional guidelines
On days -2, patients will receive CD4+/CD25+ cells intravenously.
Eligibility Criteria
You may qualify if:
- Donor will be \<75 years of age and in good health.
- Recipients will be \< or = 55 years, will have normal organ function (excluding bone marrow) and will have a Karnofsky activity assessment \> or = 90%.
- Recipients with related or unrelated donor matched at the HLA A, B, DRB1 loci, or mismatched related or unrelated (if \< 35 years old) at a single HLA A, B, DRB1 locus.
- Recipients will be eligible in one of the following disease categories
- Chronic myelogenous leukemia in accelerated phase or in post blast crisis second or greater chronic phase; or in chronic phase but intolerant of or resistant to tyrosine kinase inhibitors.
- Acute myelocytic leukemia in first or greater remission, or first, second or third relapse.
- Acute lymphocytic leukemia in the 2nd or greater bone marrow remission.
- High risk children will be transplanted in first remission if they meet criteria
- Myelodysplastic syndrome.
- Myeloproliferative Diseases - (i.e. myelofibrosis, chronic myelomonocytic leukemia (CMML))
- Juvenile myelomonocytic leukemia
- Chronic lymphocytic leukemia
- Advanced non-Hodgkin's (NHL).
- Advanced Hodgkin's disease beyond PR2 (\> CR3, \> PR3).
- Multiple Myeloma after initial therapy.
- +1 more criteria
You may not qualify if:
- donors and recipients should meet the following test criteria.
- required for donors:
- anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-priming.
- CBC, platelet count each day of apheresis, day 0 (or 1 or 2 as needed)
- required for recipients:
- anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daniel J.Weisdorf, M.D
- Organization
- Masonic Cancer Center, University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Weisdorf, MD
Masonic Cancer Center, University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
October 1, 2001
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
January 22, 2021
Results First Posted
January 22, 2021
Record last verified: 2020-12