RECRUITING

Cord Blood Transplant in Adults with Blood Cancers

Conditions

Acute Myelogenous Leukemia (AML)Acute Lymphoblastic Leukemia (ALL)Chronic Myelogenous Leukemia (CML)Myelodysplastic Syndromes (MDS)Myeloproliferative Disorder Non-Hodgkin's Lymphoma Cord Blood Transplant CYCLOPHOSPHAMIDE (CYTOXAN)CYCLOSPORINE A FLUDARABINE MYCOPHENOLATE MOFETIL (MMF)THIOTEPA 23-143

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults

Quick Facts

Study Start:2023-05-22

Study Completion:2028-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05884333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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. * 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. * 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. * 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. \[Taken from the Cord Blood Summary\]	* 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.

Inclusion Criteria

Exclusion 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
* 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.
* 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.
* 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.
* 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. \[Taken from the Cord Blood Summary\]

* 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.

Contacts and Locations

Study Contact

Ioannis Politikos, MD

CONTACT

646-608-3773

ABMTTRIALS@mskcc.org

Juliet Barker, MBBS

CONTACT

646-608-3756

Principal Investigator

Ioannis Politikos, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Ioannis Politikos, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-22

Study Completion Date2028-05-22

Study Record Updates

Study Start Date2023-05-22

Study Completion Date2028-05-22

Terms related to this study

Keywords Provided by Researchers

Cord Blood Transplant
CYCLOPHOSPHAMIDE (CYTOXAN)
CYCLOSPORINE A
FLUDARABINE
MYCOPHENOLATE MOFETIL (MMF)
THIOTEPA
23-143

Additional Relevant MeSH Terms

Acute Myelogenous Leukemia (AML)
Acute Lymphoblastic Leukemia (ALL)
Chronic Myelogenous Leukemia (CML)
Myelodysplastic Syndromes (MDS)
Myeloproliferative Disorder
Non-Hodgkin's Lymphoma