Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Cyclophosphamide Followed by Intravenous Busulfan as Conditioning for Hematopoietic Cell Transplantation in Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome.
Verified date | December 2017 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is studying the side effects and how well giving cyclophosphamide and busulfan followed by donor stem cell transplant works in treating patients with myelofibrosis, acute myeloid leukemia, or myelodysplastic syndrome. Giving chemotherapy, such as cyclophosphamide and busulfan, before a donor stem cell transplant helps stops the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening
Status | Completed |
Enrollment | 52 |
Est. completion date | June 2013 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 65 Years |
Eligibility |
Inclusion Criteria: - Idiopathic myelofibrosis (CIMF) - Myelofibrosis developing with polycythemia vera or essential thrombocythemia - Acute myeloid leukemia with or without antecedent hematologic disorder, at any disease stage (complete remission, minimal residual disease, or relapsed leukemia) - Myelodysplastic syndrome of any World Health Organization (WHO) or French-American-British (FAB) category, at any disease stage - Less than 61 years of age if transplanted from an unrelated donor, or less than 66 years of age if transplanted from a related donor - Receiving unmanipulated peripheral blood stem cells from an human leukocyte antigen (HLA)-identical or 1-allele-mismatched related or unrelated donor, or receiving G-CSF-stimulated bone marrow if co-enrolled on Fred Hutchinson Cancer Research Center (FHCRC) protocol 2250 - With a Karnofsky Performance score of > 70% at the time of pre-transplant evaluation - Able to give informed consent (if >= 18 years of age), or with a legal guardian capable of giving consent (if < 18 years of age) - DONOR: HLA-identical or 1-allele-mismatched related or unrelated donors (by high resolution typing) - DONOR: Undergoing peripheral blood stem cell harvest or G-CSF-stimulated bone marrow harvest (bone marrow permitted only as part of FHCRC protocol 2250) - DONOR: In good general health, with a Karnofsky performance score of > 80% - DONOR: Able to give informed consent (if >= 18 years of age), or with a legal guardian able to give informed consent (if < 18 years of age and donating for a related transplant) Exclusion Criteria: - Without an HLA-identical or 1-allele-mismatched related or unrelated donor - With human immunodeficiency virus (HIV) positivity or active infectious hepatitis - Receiving a medication known to strongly inhibit enzymes in the CYP450 pathway, and which, in the judgment of the consenting provider, cannot be safely discontinued for the duration of conditioning - Whose life expectancy is severely limited by diseases other than the hematologic disorder for which they are undergoing HCT (HCT-comorbidity index [CI] > 3) - Women who are pregnant or lactating - With known hypersensitivity to BU or CY - With hepatic dysfunction as evidenced by total bilirubin or AST > 2x the upper limit of normal, or evidence of synthetic dysfunction or cirrhosis - With impaired renal function, as evidenced by creatinine clearance < 50% of expected, creatinine > 2x the upper limit of normal, or dialysis dependence - With impaired pulmonary function, as evidenced by pO2 < 70 mm Hg and diffusing capacity of carbon monoxide (DLCO) < 70% predicted or by pO2 < 80 mm Hg and DLCO < 60%, or receiving continuous supplementary oxygen - With impaired cardiac function, as evidenced by ejection fraction < 35% or active coronary artery disease - Unable to give informed consent - DONOR: Deemed unable to undergo stem cell collection, for any reason - DONOR: HIV-positive, or hepatitis B or C antigen-positive - DONOR: Women with a positive pregnancy test - DONOR: Unable to give informed consent (if >= 18 years of age), or without a legal guardian able to give informed consent (if <18 years of age) |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of Cyclophosphamide/Busulfan Regimen in Reducing Regimen-related Liver Toxicity | Number of patients with regimen-related liver toxicity. Diagnoses will be made according to the established criteria initially proposed in 1984 by McDonald et al. | Up to day +20 | |
Primary | Non-relapse Mortality (NRM) (Patients With AML/MDS) | Cumulative incidence rate with death as a competing risk, assessed at day 100. | Up to day 200 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01564277 -
Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
Completed |
NCT02484391 -
CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma
|
Phase 1 | |
Active, not recruiting |
NCT02204085 -
A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
Terminated |
NCT00387426 -
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
|
Phase 2 | |
Active, not recruiting |
NCT01056614 -
Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies
|
Phase 2 | |
Completed |
NCT00093418 -
S0432 Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia
|
Phase 2 | |
Completed |
NCT00070551 -
GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Completed |
NCT00052520 -
Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
|
Phase 1/Phase 2 | |
Terminated |
NCT00052598 -
Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Terminated |
NCT00049582 -
Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT01798901 -
AR-42 and Decitabine in Treating Patients With Acute Myeloid Leukemia
|
Phase 1 | |
Terminated |
NCT01876953 -
Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
Completed |
NCT02070458 -
Ixazomib, Mitoxantrone Hydrochloride, Etoposide, and Intermediate-Dose Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT02583893 -
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
|
Phase 2 | |
Completed |
NCT01555268 -
Trebananib With or Without Low-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
|
Phase 1 |