Cord Blood Transplant in Adults With Blood Cancers
Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tracks adults with certain blood cancers who receive a cord blood transplant using MSK’s standard care plan. Researchers will study side effects, cancer returning, immune system recovery, and graft-versus-host disease, when donor cells attack the patient’s body.
Cord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK has developed a standard ("optimized") practice for cord blood transplant (CBT). This optimized practice includes how patients are evaluated for transplant, the conditioning treatment (standard chemotherapy and total body irradiation therapy) given to prepare the body for transplant, the amount of stem cells transplanted, and how patients are followed during and after transplant.The purpose of this study is to collect information about participant outcomes after CBT following MSK's optimized practice. The researchers will look at outcomes of the CBT treatment such as side effects, disease relapse, GVHD, and immune system recovery after CBT treatment.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have one of the blood cancers listed below and meet its treatment and test rules.
- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL): be in a first remission with a high risk of cancer returning, or a second or later remission. Remission means cancer signs have gone down or disappeared; some abnormal test results are allowed.
- Certain other acute leukemias: have less than 5% blasts, which are immature blood cells. Some abnormal test results are allowed.
- Myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD), which affect blood cell growth: meet the study’s risk rules, without myelofibrosis (bone marrow scarring). Bone marrow blasts must be below 10%, and infection-fighting blood cells must be above the required level.
- Non-Hodgkin lymphoma: have a high risk of cancer returning or worsening. Fast-growing types must show complete remission on scans. Slow-growing B-cell types must have worsened at least twice and then partly or fully responded on scans.
- Blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer: have no visible cancer signs when cells are checked under a microscope.
- Be able to do most daily activities and meet all required kidney, liver, lung, heart, blood protein, and overall health test limits.
- Have two suitable cord blood units available that meet matching, cell count, and storage rules, plus at least one backup unit.
Who can't join
- Have myelofibrosis, or another cancer with moderate to severe bone marrow scarring.
- Have cancer still present in the brain, spinal cord, or fluid around them at screening.
- Have received checkpoint inhibitors, a type of immune treatment, in the past 12 months.
- Have had two stem cell transplants, any transplant using another person’s cells, or a transplant using your own cells in the past 12 months.
- Have had radiation that would make the planned whole-body radiation unsafe, or do not meet the required activity and organ health limits.
- Have an active, uncontrolled infection at transplant, HIV, or a positive HTLV-1 virus blood test.
- Are pregnant or breastfeeding.
- You or your guardian cannot give informed consent, or you cannot follow the treatment, support care, long-term follow-up, and research testing plan.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * I. Acute myelogenous leukemia (AML): * Complete first remission (CR1) at high risk for relapse such as any of the following: * Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPD). * Therapy-related AML. * Presence of extramedullary leukemia at diagnosis. * Requirement for 2 or more inductions to achieve CR1. * Intermediate or high ELN2017 genetic risk AML. * Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician. * Other high-risk features not defined above. * Complete second remission (CR2) or greater (CR2+). * Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible II. Acute lymphoblastic leukemia (ALL): * Complete first remission (CR1) at high risk for relapse such as any of the following: * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality. * Failure to achieve MRD- complete remission after induction therapy. * Persistence or recurrence of minimal residual disease on therapy. * Any patient unable to tolerate consolidation and/or maintenance chemotherapy as would have been deemed appropriate by the treating physician. * Other high-risk features not defined above. * Complete second remission (CR2) or greater (CR2+). Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible. III. Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible. IV. Myelodysplastic Syndromes (MDS) and Myeloproliferative Disorders (MPD) other than myelofibrosis: * International prognostic scoring system (IPSS) risk score of INT-2 or high risk at the time of diagnosis. * Any IPSS risk category if life-threatening cytopenia(s) exists. * Any IPSS risk category with karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia. * MDS/MPD overlap syndromes without myelofibrosis. * MDS/ MPD patients must have less than 10% bone marrow myeloblasts and ANC \> 0.2 (growth factor supported if necessary) at transplant work-up. V. Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission: Eligible patients with aggressive histologies (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histologies) in CR by PET/CT imaging. o Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2 nd or subsequent progression with PR or CR by PET/CT imaging. VI. Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission. Organ Function and Performance Status Criteria: * Karnofsky score equal or greater than 80% (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient). * Calculated creatinine clearance \> 70 ml/min. * Bilirubin \< 1.5 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis). * ALT \< 3 x upper limit of normal (ULN). * Pulmonary function: Spirometry (FVC and FEV1) and corrected DLCO) \> 60% predicted. * Left ventricular ejection fraction (MOD-bp)\> 50%. * Albumin \> 3.0. * Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) ≤5. Graft criteria: Two CB units will be selected according to current MSKCC CB unit selection algorithm. High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed. Unit selection will occur based on HLA-match, total nucleated cell (TNC) and CD34+ cell dose adjusted per patient body weight. The bank of origin will also be considered. Donor specific HLA antibodies, if present, will also be taken into consideration and may influence the selection of the graft. * Each CB unit must be at least 3/8 HLA-matched to the patient considering high-resolution 8-allele HLA typing. \[Taken from the Cord Blood Summary\] * Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 10\^7 TNC/ recipient body weight (TNC/ kg). \[Taken from the Cord Blood Summary\] * Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.5 x 10\^5 CD34+ cells/ recipient body weight (CD34+ cells/kg). \[Taken from the Cord Blood Summary\] * A minimum of one unit will be reserved as a backup graft. \[Taken from the Cord Blood Summary\] * Each CB unit will be required to be cryopreserved in standard cryovolume (24-27 ml/s per unit or per bag if unit in two bags) and be red blood cell depleted. \[Taken from the Cord Blood Summary\] Exclusion Criteria: * Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis. * Patients with persistent with CNS involvement in CSF or CNS disease at time of screening * Prior checkpoint inhibitors/ blockade in the last 12 months. * Two prior stem cell transplants of any kind. * One prior autologous stem cell transplant within the preceding 12 months. * Prior allogeneic transplantation. * Prior involved field radiation therapy that would preclude safe delivery of 400cGy TBI in the opinion of Radiation Oncology. * Active and uncontrolled infection at time of transplantation. * HIV infection. * Seropositivity for HTLV-1. * Inadequate performance status/ organ function. * Pregnancy or breast feeding. * Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.
Study sites (1)
NY
- Memorial Sloan Kettering Cancer Center · New York, NY 10065Ann Jakubowski, MD, PhD · Study contact · 646-608-3782 · ABMTTrials@mskcc.orgAndromach Scaradavou, MD · Study contact · 212-639-3267More trials in New York