Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromePhase 3NCT00322101
Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
A Phase 3 study testing total-body irradiation, allogeneic hematopoietic stem cell transplantation and cyclophosphamide in people with Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome and Acute Myeloid Leukemia/Transient Myeloproliferative Disorder, run by Fred Hutchinson Cancer Center at 8 sites in 2 countries.
Trial summary
RATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Acute Myeloid Leukemia/Transient Myeloproliferative Disorder, Adult Acute Myeloid Leukemia in Remission
- What is being tested?
- total-body irradiation, allogeneic hematopoietic stem cell transplantation and cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2006to Oct 2014
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Myelodysplastic syndrome (MDS) or transformed acute myelogenous leukemia (transformed from MDS)
- De novo acute myelogenous leukemia (AML) beyond first remission
- Intermediate or high risk de novo AML in first complete response (at FHCRC unrelated donor recipients only)
- Chemotherapy required prior to HCT for all patients:
- A) Interval between start of a cycle of cytoreductive chemotherapy and infusion of donor stem cells must be at least 30 days; chemotherapy received for disease maintenance will be allowed during this time period
- B) All patients must have < 5% myeloblasts based on marrow morphology performed within 21 days prior to start of conditioning regimen and at least 3-4 weeks after the start of pre-transplant cytoreductive chemotherapy
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- C) All patients must have no circulating peripheral blood myeloblasts present based on morphologic analysis
- Age 65 years or under for patients with related donors; age 60 years or under for patients with unrelated donors
- HCT-Specific Comorbidity Index Score (HCT-CI) < 3
- Related donor (age > 12 years, nonsyngeneic) or unrelated donor, HLA phenotypically or genotypically identical at the allele level at A,B,C,DRQ1, and CBQ1
- DONOR: Related or unrelated donors who are genotypically or phenotypically matched by high resolution HLA typing (HLA-A, B, C, DRB1, and DQB1); class 1 single allele mismatch allowed
- DONOR: Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A*0101 and the donor is A*0201, and this type of mismatch is not allowed
- DONOR: A positive anti-donor cytotoxic crossmatch or flow cytometric assay is an absolute donor exclusion at FHCRC/SCCA
- DONOR: Age >= 12 years
- DONOR: Donors must consent to PBSC mobilization with G-CSF and leukaphereses; bone marrow as a source of stem cells will not be allowed
- DONOR: Donor must have adequate veins for leukaphereses or agree to placement of central venous catheter (femoral, subclavian)
Who cannot join
- HIV seropositivity
- Fungal infections with radiographic progression after appropriate therapy for greater than one month
- Organ dysfunction
- Symptomatic coronary artery disease or ejection fraction < 35%
- DLCO < 65%, FEV1 < 65% or receiving supplementary continuous oxygen
- Liver function abnormalities: Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, histology, and the degree of portal hypertension; patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease will be excluded
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- Karnofsky Performance Score < 70
- Lansky-Play Performance Score < 70 for pediatric patients
- Life expectancy severely limited (< 2 years) by disease other than MDS/AML
- Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment
- Patients with active non-hematological malignancies except:
- A) Patients with follicular or low grade lymphoma will be eligible as long as they have not and do not require active treatment for control of their disease
- B) Patients with localized non-melanoma skin malignancies
- Patients with poorly controlled hypertension who are unable to have blood pressure stabilized below 150/90 mm Hg on standard medication
- Females who are pregnant or breastfeeding
- Patients with systemic, uncontrolled infections
- Active CNS disease as identified by positive CSF cytospin
- DONOR: Identical twin
- DONOR: Age < 12 years
- DONOR: Pregnancy
- DONOR: HIV seropositivity
- DONOR: Inability to achieve adequate venous access
- DONOR: Known adverse reaction to G-CSF
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Emory University
Altanta, Georgia, 30322
HealthOne Presbyterian St. Lukes Medical Center
Denver, Colorado
Medical College Wisconsin
Milwaukee, Wisconsin
Weill Cornell University
New York, New York, 10021
University of Utah
Salt Lake City, Utah, 84112
Veterans Administration Center-Seattle
Seattle, Washington, 98108
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplant Conditioning in Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
RATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It may also 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. It is not yet known whether low-dose chemotherapy and total-body radiation therapy is more effective than high-dose chemotherapy in treating patients with myelodysplastic syndrome or acute myeloid leukemia.
PURPOSE: This phase III trial is studying low-dose conditioning to see how well it works compared to high-dose conditioning followed by peripheral blood stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia
Read the detailed description
OBJECTIVES:
- Determine whether the conditioning intensity affects outcomes after HCT in patients with MDS or AML who have < 5% marrow myeloblasts at the time of HCT.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I (Nonmyeloablative regimen):
CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
Arm II (Myeloablative regimen):
CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Acute Myeloid Leukemia/Transient Myeloproliferative Disorder, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Being tested
- total-body irradiation, allogeneic hematopoietic stem cell transplantation, cyclophosphamide, mycophenolate mofetil, busulfan
- Medical subject headings
- Leukemia, Myeloid, Acute, Myeloproliferative Syndrome, Transient, Congenital Abnormalities, Chromosome 5q Deletion Syndrome, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total-body irradiationRadiation
Also called TBI
Radiation
allogeneic hematopoietic stem cell transplantationProcedure or surgery
Undergo allogeneic transplantation
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given IV
Also called Cellcept, MMF
Given orally
busulfanDrug
Also called BSF, BU, Misulfan, Mitosan
Given IV or orally
cyclosporineDrug
Also called ciclosporin, cyclosporin, cyclosporin A, CYSP
Given IV or orally
Also called 2-F-ara-AMP, Beneflur, Fludara
Given IV
peripheral blood stem cell transplantationProcedure or surgery
Also called PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Undergo transplantation
nonmyeloablative allogeneic hematopoietic stem cell transplantationProcedure or surgery
Undergo allogeneic transplantation
laboratory biomarker analysisOther
Correlative studies
cytogenetic analysisGenetic
Correlative studies
flow cytometryOther
Correlative studies
fluorescence in situ hybridizationGenetic
Also called fluorescence in situ hybridization (FISH)
Correlative studies
Also called pharmacological studies
Correlative studies
polymorphism analysisGenetic
Correlative studies
tacrolimusDrug
Also called FK 506, Prograf
Given IV or orally
methotrexateDrug
Also called amethopterin, Folex, methylaminopterin, Mexate
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Nonmyeloablative regimen) | Experimental | CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96. Receives: Radiation: total-body irradiation; Drug: mycophenolate mofetil; Drug: cyclosporine; Drug: fludarabine phosphate; Procedure: peripheral blood stem cell transplantation; Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation; Other: laboratory biomarker analysis; Genetic: cytogenetic analysis; Other: flow cytometry; Genetic: fluorescence in situ hybridization; Other: pharmacological study; Genetic: polymorphism analysis |
| Arm II (Myeloablative regimen) | Experimental | CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Receives: Procedure: allogeneic hematopoietic stem cell transplantation; Drug: cyclophosphamide; Drug: busulfan; Drug: fludarabine phosphate; Procedure: peripheral blood stem cell transplantation; Other: laboratory biomarker analysis; Other: flow cytometry; Genetic: fluorescence in situ hybridization; Other: pharmacological study; Genetic: polymorphism analysis; Drug: tacrolimus; Drug: methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: At 2 years
Secondary outcomes (5)
Progression-free Survival
IWG criteria was used to determine disease progression
Measured: After stem cell infusion to date of last follow up.
Non-relapse Mortality
Measured: At 100 days
Donor Cell Engraftment
Chimerism analysis was performed in patients who recieved nonmyeloablative tranplsnat. In this group the definition of engraftment was a CD3 count greater than 50%. In the myeloablative group, engraftment was defined as an absolute neutrophil count greater than 50%.
Measured: After stem cell infusion to day 28
Incidence of Disease Progression/Relapse
Disease progression/relapse was defined by IWG criteria
Measured: After stem cell infusion to date of last follow up.
Incidence and Severity of Acute and Chronic Graft-vs-host Disease
Measured: After transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2012
- Study completionOct 2014
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 Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Scott, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322101
- Sponsor's protocol ID
- 1992.00
- Other IDs
- NCI-2010-00737, P01CA078902, K23HL084054, P01CA018029, P01HL036444
- Status last verified
- Oct 2014
- First submitted
- 2 May 2006
- Last updated
- 31 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplant Conditioning in Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00322101
- Acronym / sponsor ID
- 1992.00
- Conditions
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Acute Myeloid Leukemia/Transient Myeloproliferative Disorder, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2006
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 May 2006 (estimated)
- Results
- Posted 28 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It may also 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. It is not yet known whether low-dose chemotherapy and total-body radiation therapy is more effective than high-dose chemotherapy in treating patients with myelodysplastic syndrome or acute myeloid leukemia.
PURPOSE: This phase III trial is studying low-dose conditioning to see how well it works compared to high-dose conditioning followed by peripheral blood stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia
Detailed description
OBJECTIVES:
- Determine whether the conditioning intensity affects outcomes after HCT in patients with MDS or AML who have < 5% marrow myeloblasts at the time of HCT.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I (Nonmyeloablative regimen):
CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
Arm II (Myeloablative regimen):
CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Nonmyeloablative regimen) | Experimental | Radiation: total-body irradiation, Drug: mycophenolate mofetil, Drug: cyclosporine, Drug: fludarabine phosphate, Procedure: peripheral blood stem cell transplantation, Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation, Other: laboratory biomarker analysis, Genetic: cytogenetic analysis, Other: flow cytometry, Genetic: fluorescence in situ hybridization, Other: pharmacological study, Genetic: polymorphism analysisCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96. |
| Arm II (Myeloablative regimen) | Experimental | Procedure: allogeneic hematopoietic stem cell transplantation, Drug: cyclophosphamide, Drug: busulfan, Drug: fludarabine phosphate, Procedure: peripheral blood stem cell transplantation, Other: laboratory biomarker analysis, Other: flow cytometry, Genetic: fluorescence in situ hybridization, Other: pharmacological study, Genetic: polymorphism analysis, Drug: tacrolimus, Drug: methotrexateCONDITIONING: Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4. TRANSPLANTATION: Patients undergo PBSC infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Myelodysplastic syndrome (MDS) or transformed acute myelogenous leukemia (transformed from MDS)
- De novo acute myelogenous leukemia (AML) beyond first remission
- Intermediate or high risk de novo AML in first complete response (at FHCRC unrelated donor recipients only)
- Chemotherapy required prior to HCT for all patients:
- A) Interval between start of a cycle of cytoreductive chemotherapy and infusion of donor stem cells must be at least 30 days; chemotherapy received for disease maintenance will be allowed during this time period
Key exclusion criteria (23 listed)
- HIV seropositivity
- Fungal infections with radiographic progression after appropriate therapy for greater than one month
- Organ dysfunction
- Symptomatic coronary artery disease or ejection fraction < 35%
- DLCO < 65%, FEV1 < 65% or receiving supplementary continuous oxygen
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 |
|---|---|---|
| total-body irradiationAlso: TBIRadiation | Radiation | Arm I (Nonmyeloablative regimen) |
| allogeneic hematopoietic stem cell transplantationUndergo allogeneic transplantation | Procedure or surgery | Arm II (Myeloablative regimen) |
| cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanGiven IV | Drug | Arm II (Myeloablative regimen) |
| mycophenolate mofetilAlso: Cellcept, MMFGiven orally | Drug | Arm I (Nonmyeloablative regimen) |
| busulfanAlso: BSF, BU, Misulfan, MitosanGiven IV or orally | Drug | Arm II (Myeloablative regimen) |
| cyclosporineAlso: ciclosporin, cyclosporin, cyclosporin A, CYSPGiven IV or orally | Drug | Arm I (Nonmyeloablative regimen) |
| fludarabine phosphateAlso: 2-F-ara-AMP, Beneflur, FludaraGiven IV | Drug | Arm I (Nonmyeloablative regimen), Arm II (Myeloablative regimen) |
| peripheral blood stem cell transplantationAlso: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cellUndergo transplantation | Procedure or surgery | Arm I (Nonmyeloablative regimen), Arm II (Myeloablative regimen) |
| nonmyeloablative allogeneic hematopoietic stem cell transplantationUndergo allogeneic transplantation | Procedure or surgery | Arm I (Nonmyeloablative regimen) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (Nonmyeloablative regimen), Arm II (Myeloablative regimen) |
| cytogenetic analysisCorrelative studies | Genetic | Arm I (Nonmyeloablative regimen) |
| flow cytometryCorrelative studies | Other | Arm I (Nonmyeloablative regimen), Arm II (Myeloablative regimen) |
| fluorescence in situ hybridizationAlso: fluorescence in situ hybridization (FISH)Correlative studies | Genetic | Arm I (Nonmyeloablative regimen), Arm II (Myeloablative regimen) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (Nonmyeloablative regimen), Arm II (Myeloablative regimen) |
| polymorphism analysisCorrelative studies | Genetic | Arm I (Nonmyeloablative regimen), Arm II (Myeloablative regimen) |
| tacrolimusAlso: FK 506, PrografGiven IV or orally | Drug | Arm II (Myeloablative regimen) |
| methotrexateAlso: amethopterin, Folex, methylaminopterin, MexateGiven IV | Drug | Arm II (Myeloablative regimen) |
Primary outcome
Overall Survival
Time frame: At 2 years
5 secondary outcomes
Progression-free Survival
Time frame: After stem cell infusion to date of last follow up.
Non-relapse Mortality
Time frame: At 100 days
Donor Cell Engraftment
Time frame: After stem cell infusion to day 28
Incidence of Disease Progression/Relapse
Time frame: After stem cell infusion to date of last follow up.
Incidence and Severity of Acute and Chronic Graft-vs-host Disease
Time frame: After transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Leukemia, Myelodysplastic Syndromes
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.
Bart Scott principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing total-body irradiation, allogeneic hematopoietic stem cell transplantation and cyclophosphamide in people with Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome and Acute Myeloid Leukemia/Transient Myeloproliferative Disorder, run by Fred Hutchinson Cancer Center at 8 sites in 2 countries.
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 23 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: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2013). 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?
Overall Survival (time frame: At 2 years). 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 31 Oct 2014.