Total Marrow and Lymphoid Irradiation for AML and MDS
This study is testing a new way to prepare older patients (age 50 and above) for a stem cell transplant. It combines total marrow and lymphoid irradiation (TMLI) with two chemotherapy drugs, fludarabine and melphalan. This treatment is for people with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that hasn't responded to previous treatments or has come back. The goal is to see if this combination can help patients live longer without their leukemia returning. The study is currently unclear about its recruitment status and plans to enroll 35 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 35 participants aged 50 and older.
- What's involved
- Participants will undergo urine and blood sample collection, bone marrow biopsies, CT scans, and echocardiography tests. The duration of these commitments is not fully specified.
- Compensation
- Not stated in the trial record.
- Follow-up
- Leukemia-free survival will be assessed for 2 years after the stem cell transplant.
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NCT07582172
Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome
Recruiting
PHASE2Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~35 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow BiopsyComputed TomographyEchocardiography TestFludarabine PhosphateMelphalan
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Leukemia-free survival
Measured over From the date of stem cell infusion to the date of first observation of relapse/progression, or date of death, whichever comes first, assessed at 2 years post-hematopoietic cell transplantation (HCT)
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Monzr M Al Malki · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: ≥ 50 years (no upper age limit)
Note: Patients ≥ 18 years and \< 50 years are also included if they are not candidates for myeloablative conditioning regimens due to comorbidities or active disease
Karnofsky or Lansky performance status ≥ 70
Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories:
Acute myeloid leukemia (AML):
Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for 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), or all patient in intermediate risk groups
Patients with active disease:
Morphologically
Minimal residual disease (MRD) testing (MRD+ through flow cytometry, cytogenetics, or molecular assays)
Myelodysplastic syndrome/chronic myelomonocytic leukemia (CMML) (MDS) with ≥ 10% blast
Patients must have an human leukocyte antigen (HLA) (A, B, C, and DRB1) identical sibling or a 8/8 (A, B, C, and DR) allele matched unrelated donor who is willing to donate primed blood stem cells
Serum direct bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)
Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)
Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)
Creatinine clearance of ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 35 days prior to day 1 of protocol therapy unless otherwise stated)
Left ventricular ejection fraction (LVEF) ≥ 50%
Note: To be performed within 35 days prior to day 1 of protocol therapy
If able to perform pulmonary function tests: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)
Note: To be performed within 35 days prior to day 1 of protocol therapy
If unable to perform pulmonary function tests: Oxygen (O2) saturation \> 92% on room air
Note: To be performed within 35 days prior to day 1 of protocol therapy
Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)
If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Meets institutional and federal requirements for infectious disease titer requirements
Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 35 days prior to day 1 of protocol therapy unless otherwise stated)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion
Allogeneic stem cell transplant or autologous HCT within 1 year prior to day 1 of protocol therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days of day 1 of protocol therapy
Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). TKIs can also be given up to 3-5 days before conditioning regimen
More than three previous lines of intensive chemotherapy, where the regimen intent was to induce remission
Co-enrollment in other clinical trials involving post-HCT maintenance interventions or any study with potential to affect disease-free survival is not allowed
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
Clinically significant uncontrolled illness
Active infection not responding to antibiotics
Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Leukemia-free survivalFrom the date of stem cell infusion to the date of first observation of relapse/progression, or date of death, whichever comes first, assessed at 2 years post-hematopoietic cell transplantation (HCT)
Will be calculated using the Kaplan-Meier method. Point estimates and 95% confidence intervals will be provided.