Acute Myeloid Leukemia Clinical Trial
Official title:
Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells to Facilitate the Engraftment of a Single CCR5Δ32 Homozygous or Heterozygous Cord Blood Unit in Patients With HIV and Hematological Malignancies
Verified date | May 2024 |
Source | Fred Hutchinson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies the side effects of a cord blood transplant using dilanubicel and to see how well it works in treating patients with human immunodeficiency virus (HIV) positive hematologic (blood) cancers. After a cord blood transplant, the immune cells, including white blood cells, can take a while to recover, putting the patient at increased risk of infection. Dilanubicel consists of blood stem cells that help to produce mature blood cells, including immune cells. Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total body irradiation is a type of whole-body radiation. Giving chemotherapy and total-body irradiation before a cord blood transplant with dilanubicel may help to kill any cancer cells that are in the body and make room in the patient's bone marrow for new stem cells to grow and reduce the risk of infection.
Status | Terminated |
Enrollment | 1 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 65 Years |
Eligibility | Inclusion Criteria: - >= 6 months to =< 65 years - Treatment with combination antiretroviral therapy (cART) for at least 1 month before enrollment - Viral load < 5000 copies/ml plasma on cART - Disease criteria - Acute myeloid leukemia - High risk in first complete remission (CR1), >= 2 cycles to obtain complete remission (CR), erythroblastic or megakaryocytic leukemia; >= in second complete remission (CR2) - All patients must be in CR as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of >= 15% - Patients for whom adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible. Specimen for morphologic assessment, including possible repeat procedures will be obtained (as possible). These patients must be discussed with the lead principal investigator, Filippo Milano prior to enrollment - Acute lymphoblastic leukemia - High risk CR1 (for example, but not limited to: t(9;22), t(1;19), t(4;11) or other mixed-lineage leukemia [MLL] rearrangements, hypodiploid); greater than 1 cycle to obtain CR; >= CR2 - All patients must be in CR as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of >= 15% - Patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible. Specimen for morphologic assessment, including possible repeat procedures will be obtained (as possible). These patients must be discussed with the lead principal investigator, Filippo Milano prior to enrollment - Chronic myelogenous leukemia excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate - Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or high risk (i.e., refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEBt]) or refractory anemia with severe pancytopenia or high-risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology - Other hematologic malignancy such as non-Hodgkin lymphomas. Fred Hutch site: These patients must be presented at Patient Care Conference (PCC) prior to enrollment, given potential competing eligibility on auto-transplant protocols. Participating centers: These patients must be discussed with the lead principal investigator, Filippo Milano prior to enrollment - Karnofsky (>= 16 years old) >= 70% - Lansky (< 16 years old) >= 50% - Adults: Calculated creatinine clearance must be > 60 mL and serum creatinine =< 2 mg/dL - Children (< 18 years old): Calculated creatinine clearance must be > 60 mL/min - Total serum bilirubin must be < 3 mg/dL - Transaminases must be < 3 x the upper limit of normal - Diffusion capacity of the lung for carbon monoxide (DLCO) corrected > 50% normal or for pediatric patients in whom DLCO cannot be measured has adequate pulmonary function - Left ventricular ejection fraction > 45% OR - Shortening fraction > 26% - Ability to understand and the willingness to sign a written informed consent document (adult subject or parent/legal guardian of minor subject) Exclusion Criteria: - Uncontrolled viral or bacterial infection at the time of study enrollment - Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval - Pregnant or breastfeeding - Prior myeloablative transplant within the last 6 months - Extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation - Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy. Diagnostic lumbar puncture to be performed |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Cleveland Cord Blood Center | Cleveland | Ohio |
United States | University of California San Francisco | San Francisco | California |
United States | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Center | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary graft failure rejection | Will be defined by no neutrophil recovery by day 45 (regardless of donor chimerism) or autologous recovery (neutrophil recovery but < 10% donor chimerism in blood and bone marrow) by day 45. | Up to day 45 | |
Secondary | Incidence of infusion toxicities | Defined as Common Terminology Criteria for Adverse Events version 5.0 grade >= 3 events. | Within the first 24 hours after infusion | |
Secondary | Neutrophil recovery | Will be defined as the first day of 2 consecutive days of absolute neutrophil count >= 500 after the first post-cord blood transplant nadir. | Up to 2 years | |
Secondary | Platelet engraftment | Will be defined as the first day of a platelet count > 20,000/ul with subsequent transfusions for 7 days. | Up to 2 years | |
Secondary | Severe (grades III-IV) acute graft versus host disease (GVHD) | Will be defined by the 2014 National Institutes of Health (NIH) criteria. | Up to 2 years | |
Secondary | Chronic GVHD | Will be defined by the 2014 NIH criteria. | Up to 2 years | |
Secondary | Non-relapse mortality | Will be defined as death without a prior relapse. | Up to day 180 | |
Secondary | Human immunodeficiency virus (HIV) plasma viral load | Pre and post-transplant | ||
Secondary | Immune homeostasis | Concentration of immunity cells per microliters after transplant | Up to 2 years | |
Secondary | Immune reconstitution | Concentration of immunity cells per microliters after transplant | Up to 2 years | |
Secondary | Change in HIV-1 induced inflammatory immune responses | HIV viral load by PCR (copies per milliliter; mL) | Up to 2 years | |
Secondary | HIV rebound following antiretroviral therapy (ART) cessation | HIV viral load by PCR (copies per milliliter; mL) | Up to 2 years | |
Secondary | Viral kinetics following ART cessation | HIV viral load by PCR (copies per milliliter; mL) | Up to 2 years |
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