Leukemia, Myeloid, ChronicNCT00176930
Stem Cell Transplant for Hematological Malignancy
A study testing Stem Cell Transplant, Cyclophosphamide and Total Body Irradiation in people with Leukemia, Myeloid, Chronic and AML, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 55 years
- Conditions the study is for
- Leukemia, Myeloid, Chronic, AML, Leukemia, Lymphocytic, Acute
- What is being tested?
- Stem Cell Transplant, Cyclophosphamide and Total Body Irradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
- Donors and recipients signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Allogeneic Transplant for Hematological Malignancy
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.
Read the detailed description
Preparative regimen using total body irradiation (TBI) and cyclophosphamide:
- on day -6 and -5: cyclophosphamide is given,
- on day -4, -3, -2, and -1: TBI is given,
- on day 0: stem cell or bone marrow is infused.
Alternate preparative therapy for patients not able to receive TBI
The chemotherapy (cyclophosphamide and busulfan) is given with the intent of destroying the bone marrow, eliminating any cancerous and preparing for the transplant of the donor's blood stem cells by suppressing the immune system.
- Ten days before the transplant (Day 10), subjects will be admitted to the bone marrow transplant unit and placed in isolation to reduce exposure to infections. Isolation will be continued until adequate numbers of cells are present in the blood to fight infection.
- On day -9, -8, -7, -6 busulfan is given.
- On day -5, -4, -3, -2 cyclophosphamide is given.
- On day -1 no therapy is given (day of rest).
- On day 0 the donor stem cells are given intravenously. Additional cells may be given on day +1 or 2 as needed.
Transplant:
Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents. During this time, they will receive the preparative treatment outlined above. Once they have received the preparative regimen, stem cells will be obtained from the donor and given intravenously.
The new stem cells will replace the bone marrow that was damaged by the treatment for the cancer.
Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. Subjects will then be transferred from the bone marrow transplant unit and discharged from the hospital when medically ready. Subjects will be expected to return for follow-up to the bone marrow transplant clinic at specific dates as determined by their physician.
- Conditions
- Leukemia, Myeloid, Chronic, AML, Leukemia, Lymphocytic, Acute, MDS, Leukemia, Lymphocytic, Chronic, JMML
- Being tested
- Stem Cell Transplant, Cyclophosphamide, Total Body Irradiation, Busulfan, Equine ATG (ATGAM)
- Keywords
- stem cell transplant, chronic leukemia, acute leukemia, irradiation, chemotherapy
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cell TransplantBiological
Also called Bone Marrow Transplant.
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.)
CyclophosphamideDrug
Also called Cytoxan
60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
Total Body IrradiationRadiation
Also called Radiation therapy
On Day -4, -3, -2, -1 total body irradiation is given twice daily.
BusulfanDrug
Also called Busulfex, Myleran
When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
Equine ATG (ATGAM)Drug
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
CD4+/CD25+ cellsBiological
On days -2, patients will receive CD4+/CD25+ cells intravenously.
| Study group | Role | What they receive |
|---|---|---|
| PBSC: No TBI | Experimental | Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant Receives: Biological: Stem Cell Transplant; Drug: Cyclophosphamide; Drug: Busulfan |
| Marrow : No TBI | Experimental | Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant Receives: Biological: Stem Cell Transplant; Drug: Cyclophosphamide; Drug: Busulfan |
| UCB : No TBI | Experimental | Patients 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 Receives: Biological: Stem Cell Transplant; Drug: Cyclophosphamide; Drug: Busulfan |
| UCB : No TBI/Bu/Cy/ATG | Experimental | Patients 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 Receives: Biological: Stem Cell Transplant; Drug: Cyclophosphamide; Drug: Busulfan; Drug: Equine ATG (ATGAM) |
| PBSC | Experimental | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant Receives: Biological: Stem Cell Transplant; Drug: Cyclophosphamide; Radiation: Total Body Irradiation |
| Marrow | Experimental | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant Receives: Biological: Stem Cell Transplant; Drug: Cyclophosphamide; Radiation: Total Body Irradiation |
| UCB | Experimental | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant Receives: Biological: Stem Cell Transplant; Drug: Cyclophosphamide; Radiation: Total Body Irradiation |
| Co-Enroll From MT0403 | Experimental | Patients 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) Receives: Biological: Stem Cell Transplant; Drug: Cyclophosphamide; Radiation: Total Body Irradiation; Biological: CD4+/CD25+ cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Secondary outcomes (8)
Number of Participants With Neutrophil Engraftment
Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm^3 (0.5 x 10^9/L) or greater.
Measured: Day 42
Number of Participants With Acute Graft-versus-host Disease (GVHD)
Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging.
Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
Measured: Day 100
Number of Participants With Chronic Graft-Versus-Host Disease
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Determine the incidence of chronic GVHD 1 year post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
Measured: 1 year
Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant
Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
Measured: 2 years
Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant
Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
Measured: 5 years
Number of Participants Who Were Alive at 2 Year Post Transplant
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.
Measured: 2 years
Number of Participants Who Were Alive at 5 Year Post Transplant
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.
Measured: 5 years
Number of Participants Experiencing Engraftment Failure
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2001
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: replaced by another study ; Trial re-written as MT2015-29
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Leukemia, Myeloid, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Weisdorf, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176930
- Sponsor's protocol ID
- 2001LS049
- Other IDs
- MT2001-02, 0107M05202
- Status last verified
- Dec 2020
- First submitted
- 12 Sep 2005
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Transplant for Hematological Malignancy
- ClinicalTrials.gov ID
- NCT00176930
- Acronym / sponsor ID
- 2001LS049
- Conditions
- Leukemia, Myeloid, Chronic, AML, Leukemia, Lymphocytic, Acute, MDS, Leukemia, Lymphocytic, Chronic, JMML
- Keywords
- stem cell transplant, chronic leukemia, acute leukemia, irradiation, chemotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: replaced by another study ; Trial re-written as MT2015-29
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Oct 2001 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preparative regimen using total body irradiation (TBI) and cyclophosphamide:
- on day -6 and -5: cyclophosphamide is given,
- on day -4, -3, -2, and -1: TBI is given,
- on day 0: stem cell or bone marrow is infused.
Alternate preparative therapy for patients not able to receive TBI
The chemotherapy (cyclophosphamide and busulfan) is given with the intent of destroying the bone marrow, eliminating any cancerous and preparing for the transplant of the donor's blood stem cells by suppressing the immune system.
- Ten days before the transplant (Day 10), subjects will be admitted to the bone marrow transplant unit and placed in isolation to reduce exposure to infections. Isolation will be continued until adequate numbers of cells are present in the blood to fight infection.
- On day -9, -8, -7, -6 busulfan is given.
- On day -5, -4, -3, -2 cyclophosphamide is given.
- On day -1 no therapy is given (day of rest).
- On day 0 the donor stem cells are given intravenously. Additional cells may be given on day +1 or 2 as needed.
Transplant:
Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents. During this time, they will receive the preparative treatment outlined above. Once they have received the preparative regimen, stem cells will be obtained from the donor and given intravenously.
The new stem cells will replace the bone marrow that was damaged by the treatment for the cancer.
Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. Subjects will then be transferred from the bone marrow transplant unit and discharged from the hospital when medically ready. Subjects will be expected to return for follow-up to the bone marrow transplant clinic at specific dates as determined by their physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| PBSC: No TBI | Experimental | Biological: Stem Cell Transplant, Drug: Cyclophosphamide, Drug: BusulfanPatients 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 | Experimental | Biological: Stem Cell Transplant, Drug: Cyclophosphamide, Drug: BusulfanPatients 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 | Experimental | Biological: Stem Cell Transplant, Drug: Cyclophosphamide, Drug: BusulfanPatients 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 | Experimental | Biological: Stem Cell Transplant, Drug: Cyclophosphamide, Drug: Busulfan, Drug: Equine ATG (ATGAM)Patients 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 | Experimental | Biological: Stem Cell Transplant, Drug: Cyclophosphamide, Radiation: Total Body IrradiationPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| Marrow | Experimental | Biological: Stem Cell Transplant, Drug: Cyclophosphamide, Radiation: Total Body IrradiationPatients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| UCB | Experimental | Biological: Stem Cell Transplant, Drug: Cyclophosphamide, Radiation: Total Body IrradiationPatients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| Co-Enroll From MT0403 | Experimental | Biological: Stem Cell Transplant, Drug: Cyclophosphamide, Radiation: Total Body Irradiation, Biological: CD4+/CD25+ cellsPatients 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) |
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (6 listed)
- donors and recipients should meet the following test criteria.
- required for donors:
- required for recipients:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem Cell TransplantAlso: Bone Marrow Transplant.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.) | Biological | Co-Enroll From MT0403, Marrow, Marrow : No TBI, PBSC, PBSC: No TBI, UCB, UCB : No TBI, UCB : No TBI/Bu/Cy/ATG |
| CyclophosphamideAlso: Cytoxan60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. | Drug | Co-Enroll From MT0403, Marrow, Marrow : No TBI, PBSC, PBSC: No TBI, UCB, UCB : No TBI, UCB : No TBI/Bu/Cy/ATG |
| Total Body IrradiationAlso: Radiation therapyOn Day -4, -3, -2, -1 total body irradiation is given twice daily. | Radiation | Co-Enroll From MT0403, Marrow, PBSC, UCB |
| BusulfanAlso: Busulfex, MyleranWhen not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours. | Drug | Marrow : No TBI, PBSC: No TBI, UCB : No TBI, UCB : No TBI/Bu/Cy/ATG |
| Equine ATG (ATGAM)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 | Drug | UCB : No TBI/Bu/Cy/ATG |
| CD4+/CD25+ cellsOn days -2, patients will receive CD4+/CD25+ cells intravenously. | Biological | Co-Enroll From MT0403 |
Primary outcome
Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
Time frame: 2 years
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.
Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant
Time frame: 5 years
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.
8 secondary outcomes
Number of Participants With Neutrophil Engraftment
Time frame: Day 42
Number of Participants With Acute Graft-versus-host Disease (GVHD)
Time frame: Day 100
Number of Participants With Chronic Graft-Versus-Host Disease
Time frame: 1 year
Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant
Time frame: 2 years
Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant
Time frame: 5 years
Number of Participants Who Were Alive at 2 Year Post Transplant
Time frame: 2 years
Number of Participants Who Were Alive at 5 Year Post Transplant
Time frame: 5 years
Number of Participants Experiencing Engraftment Failure
Time frame: Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Weisdorf, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stem Cell Transplant, Cyclophosphamide and Total Body Irradiation in people with Leukemia, Myeloid, Chronic and AML, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.