Phase
Condition
Lymphoproliferative Disorders
Anemia
Leukemia
Treatment
Yttrium Y 90 Basiliximab
Melphalan
Allogeneic Hematopoietic Stem Cell Transplantation
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented informed consent of the participant and/or legally authorizedrepresentative
Assent, when appropriate, will be obtained per institutional guidelines
Age: >= 60 years. Note: Patients >= 18 years and < 60 years are also included ifthey are not candidates for myeloablative conditioning regimens due to comorbidities
Karnofsky performance status >= 70
Eligible patients will have a histopathological confirmed diagnosis of hematologicmalignancy in one of the following categories which express CD25 as determined byimmunohistochemistry:
Acute myelogenous leukemia:
Patients with de novo or secondary disease in unfavorable risk groupincluding poor risk cytogenetics according to National ComprehensiveCancer Network (NCCN) guidelines for acute myeloid leukemia (AML) i.e.,monosomal karyotype, -5,5q-,-7,7q-, 11q23-non t(9;11), inv (3), t(3;3),t(6;9), t(9;22) and complex karyotypes (>= 3 unrelated abnormalities), orall patient in intermediate risk groups accept patients with FLT3-NPM1+disease
Patients with a complete morphological remission (CR) with minimalresidual disease (MRD)-positive status by flow cytometry or cytogenetic
Patients with chemosensitive active disease
Acute lymphocytic leukemia:
Patients with de novo or secondary disease according to NCCN guidelinesfor acute lymphocytic leukemia (ALL) hypoploidy (< 44 chromosomes);t(v;11q23): MLL rearranged; t(9;22) (q34;q11.2); complex cytogenetics (5or more chromosomal abnormalities); high white blood cell (WBC) atdiagnosis (>= 30,000 for B lineage or >=50,000 for T lineage); iAMP21lossof 13q, and abnormal 17p
Patients with a complete morphological remission (CR) with MRD-positivestatus by flow cytometry or cytogenetics
Patients with chemosensitive active disease
Myelodysplastic syndrome in high-intermediate (int-2) and high-risk categories
A pretreatment measured creatinine clearance (absolute value) of >= 60 ml/minute (performed within 30 days prior to day 1 of protocol therapy unless otherwisestated)
Patients must have a serum bilirubin =< 2.0 mg/dl (performed within 30 days prior today 1 of protocol therapy unless otherwise stated)
Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvatetransaminase (SGPT) =< 2.5 times the institutional upper limits of normal (performedwithin 30 days prior to day 1 of protocol therapy unless otherwise stated)
Ejection fraction measured by echocardiogram or multigated acquisition scan (MUGA) >= 50% (performed within 30 days prior to day 1 of protocol therapy unless otherwisestated)
Diffusion capacity of the lung for carbon monoxide (DLCO) and forced expiratoryvolume in 1 second (FEV1) > 50% predicted (performed within 30 days prior to day 1of protocol therapy unless otherwise stated)
Agreement by females and males of childbearing potential to use an effective methodof birth control or abstain from heterosexual activity for the course of the studythrough at least 6 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men andwomen) or have not been free from menses for > 1 year (women only)
Exclusion
Exclusion Criteria:
Autologous or allogeneic hematopoietic cell transplant
Patients may not have received more than 3 prior regimens, where the regimen intentwas to induce remission
Receiving any other investigational agents or concurrent biological, intensivechemotherapy or radiation therapy for the previous 2 weeks from conditioning. Note:Receiving any other investigational agents or concurrent biological, intensivechemotherapy or radiation therapy for the previous 2 weeks from conditioning
Patients should have discontinued all previous intensive therapy, chemotherapy, orradiotherapy for 2 weeks prior to commencing therapy on this study. Note: Low dosechemotherapy or maintenance chemotherapy given within 7 days of planned studyenrollment is permitted. These include hydroxyurea, 6-meraptopurine, oralmethotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs).FLT-3 inhibitors can also be given up to 3 days before conditioning regimen
All patients with prior radiation treatment to the lung, liver, and kidney will beexcluded. For other scenarios of prior radiation treatment, up to 2000 cGy at 2 Gyper day will be allowed. Inclusion of patients with previous radiation exposure willbe determined based on the radiation oncologist medical doctor (MD) evaluation andjudgment
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to study agent
Patients with other active malignancies are ineligible for this study, other thannon-melanoma skin cancers
Patients should not have any uncontrolled illness including ongoing or activebacterial, viral or fungal infection
The recipient has a medical problem or neurologic/psychiatric dysfunction whichwould impair his/her ability to be compliant with the medical regimen and totolerate transplantation or would prolong hematologic recovery which in the opinionof the principal investigator would place the recipient at unacceptable risk
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate thepatient's participation in the clinical study due to safety concerns with clinicalstudy procedures
Prospective participants who, in the opinion of the investigator, may not be able tocomply with all study procedures (including compliance issues related tofeasibility/logistics)
DONOR: Evidence of active infection
DONOR: Medical or physical reason which makes the donor unlikely to tolerate orcooperate with growth factor therapy and leukapheresis
DONOR: Factors which place the donor at increased risk for complications fromleukapheresis or granulocyte-colony stimulating factor (G-CSF) therapy could beharvested for bone marrow (BM) if safer for the donor and if approved by principalinvestigator (PI)
DONOR: Human immunodeficiency virus (HIV) positive
Study Design
Study Description
Connect with a study center
City of Hope Medical Center
Duarte, California 91010
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.