Adult Acute Myeloid Leukemia in Remission Clinical Trial
Official title:
HLA-Mismatched Allogeneic Cellular Therapy (Microtransplantation) After Chemotherapy in Patients With Intermediate-Risk Acute Myeloid Leukemia < 60 Years
Verified date | November 2018 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies how well donor cellular therapy after cytarabine works in treating patients with intermediate-risk acute myeloid leukemia with a decrease in or disappearance of signs and symptoms of cancer. Donor cellular therapy is a short-term transfusion of cells from a family member who is incompletely matched. The use of these partially matched white blood cells may help improve response to standard chemotherapy (cytarabine) and reduce some of the risks of infection, without a permanent transplant. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving donor cellular therapy after cytarabine may kill more cancer cells.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 12, 2022 |
Est. primary completion date | November 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 59 Years |
Eligibility |
Inclusion Criteria: - PATIENT INCLUSION CRITERIA: - Acute myeloid leukemia-intermediate risk as defined by standard World Health Organization (WHO) criteria for AML (at least 20% blasts in the peripheral blood or bone marrow) at the time of initial diagnosis - Diagnosis of AML according to WHO diagnostic criteria (at least 20% blasts in the peripheral blood or bone marrow), with French-American-British (FAB) classification other than M3 (acute promyelocytic leukemia), documented by bone marrow aspiration and biopsy performed within 14 days prior to administration of 1st dose of remission induction chemotherapy - Intermediate risk based on National Comprehensive Cancer Network (NCCN) - In CR or complete remission with incomplete blood count recovery (CRi) after 1-2 induction chemotherapy documented by a bone marrow examination done within 2 weeks of starting cytarabine in this protocol - Must have achieved CR/CRi with less than 2 induction regimens that contain cytarabine and anthracycline - No 10/10 matched sibling donor available or not financially eligible for allogeneic stem cell transplantation - Must be within 3 months from the last induction regimen at the time of starting cytarabine chemotherapy in this protocol - Patient has at least one medically fit first- or second-degree family member expected to be human leukocyte antigen (HLA) mismatched at 2-9/10 loci; in addition, the prospective donor is willing to voluntarily donate hematopoietic stem cells and sign consent forms - Absolute neutrophil count (ANC) > 1500, unless due to direct bone marrow involvement of disease - Platelets > 75,000, unless due to direct bone marrow involvement of disease - Hemoglobin > 8.0 gm/dL, transfusion allowed - Serum creatinine < 2.0 x the upper limits of institutional normal (ULN) - Total bilirubin < 1.5 x the upper limits of institutional normal - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x the upper limits of institutional normal (=< 5 x ULN for patients with suspected liver involvement of leukemia) - Cardiac left ventricular ejection fraction (LVEF) > 45% - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, and estimated survival of at least 3 months - Patients must be able to understand and agree to sign an Institutional Review Board (IRB)-approved informed consent form - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study, and for two months after study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately - DONOR INCLUSION CRITERIA: - Donor screening; all donors will meet the standard blood donor criteria established by the participating local blood center, American Association of Blood Banks (AABB) - Donors will be selected from among the subject's relatives, adult children preferred - Infectious disease testing will be done per Hemacare policy and AAAB guidelines - Donor and intended recipient red cell type and compatibility will be determined - Donors will be pre-selected on the basis of HLA haploidentity - If patient is cytomegalovirus (CMV)-negative, donors who are CMV-negative will be preferred; CMV serology of the donor will be tested prior to the allogeneic cell donation; donations from CMV-positive donors to CMV-negative recipients will be given if no CMV negative donor is available, and CMV surveillance and pre-emptive treatment given as per guidelines below Exclusion Criteria: - PATIENT EXCLUSION CRITERIA: - Acute promyelocytic leukemia - High risk AML (see NCCN risk criteria) - Low risk AML (see NCCN risk criteria) - Fludarabine based therapy within 6 months of enrollment - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Who are pregnant and/or lactating - Who have had non-biopsy surgery in the last 10 days - Who have active central nervous system (CNS) disease; patients with previously treated leptomeningeal disease without evidence of remaining leukemia cells by spinal fluid will be eligible - Patients with known active autoimmune disorder - Patients known to be have active hepatitis B or C; (hepatitis B positive patients are allowed if they are on appropriate antiviral agents such as lamivudine) - Patients concurrently taking the following drugs are excluded: mycophenolate, cyclosporine, prednisone > 20 mg/day, or immunosuppressive agents - Researchers think that any life-threatening illness, condition or organ system dysfunction can damage the safety of subjects - Failure to demonstrate adequate compliance with medical therapy and follow-up - DONOR EXCLUSION CRITERIA: - Personal or family history of severe sickle cell disease or variant (unless donor has tested negative); testing for the presence of hemoglobin S is not required - Positive infectious disease test as dictated by blood collection center's standard operating procedure (SOP) - Current uncontrolled hypertension - Pregnant or breast-feeding - Currently taking lithium therapy - History of autoimmune disease |
Country | Name | City | State |
---|---|---|---|
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival (DFS) | The 2-year DFS will be estimated, and the corresponding 90% confidence intervals will be constructed. The data will be displayed using a Kaplan-Meir curve to plot the DFS over time. Calculate bilateral 95% confidential interval of mean difference of disease-free survival rate, and compare the lower limit of the bilateral 95% confidential interval and 15% superiority boundary value. | Beginning of therapy to the date of death or the date of last follow-upexamination, assessed at 2 years | |
Secondary | Cumulative incidence acute GVHD, classified as clinically significant (grades 2 to 4) or severe (grades 3 to 4) | At single time point, if univariate quantitative data of the meets the normal distribution and homogeneity of variance, perform test of univariate quantitative data, otherwise, adopt the rank-sum test of corresponding design; for univariate quantitative data under multiple time points, use mixed effects model to design variance analysis with repeated measure factors. | 6 months after microtransplant |
Status | Clinical Trial | Phase | |
---|---|---|---|
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 |
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 | |
Terminated |
NCT00589316 -
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or High-Risk Myelodysplastic Syndrome
|
Phase 1 | |
Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
Completed |
NCT01519596 -
Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
|
N/A | |
Completed |
NCT00005940 -
Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission
|
Phase 2 | |
Completed |
NCT02532231 -
Nivolumab in AML in Remission at High Risk for Relapse
|
Phase 2 | |
Completed |
NCT01254578 -
Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers
|
Phase 1 | |
Terminated |
NCT01465386 -
Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission
|
Phase 2 | |
Completed |
NCT00105001 -
Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
|
Phase 2 | |
Completed |
NCT00112593 -
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
|
N/A | |
Completed |
NCT00005799 -
Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer
|
N/A | |
Completed |
NCT00003875 -
Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With Acute Myeloid Leukemia
|
Phase 2 | |
Active, not recruiting |
NCT02396134 -
Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 2 | |
Withdrawn |
NCT01558778 -
Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant
|
N/A |