Actively Recruiting
Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome
Led by City of Hope Medical Center · Updated on 2026-04-29
33
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial tests the side effects and best dose of total marrow lymphoid irradiation along with chemotherapy, with fludarabine and melphalan, with or without thiotepa, in combination with Orca-T cells for patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS). Total marrow and lymphoid irradiation is a targeted form of total body irradiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Giving chemotherapy with medications such as thiotepa, fludarabine, and melphalan before a treatment with stem cells helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Orca-T cells take cells from a donor and remove some of the T cells and replace them with partially engineered T cells in order to induce better tolerance in patients. Giving total marrow and lymphoid irradiation and chemotherapy followed by Orca -T cells may be an effective treatment for patients with AML, ALL or MDS.
CONDITIONS
Official Title
Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant provides documented informed consent
- Agreement to allow use of archival tissue from diagnostic bone marrow biopsies (exceptions possible with investigator approval)
- Age between 60 and 75 years
- Karnofsky performance status of 70 or higher
- Confirmed diagnosis of AML, ALL, or high-intermediate/high risk MDS meeting specified disease criteria
- Serum direct bilirubin of 2.0 mg/dl or less within 30 days before treatment
- SGOT and SGPT levels 2.5 times or less the upper normal limit within 30 days before treatment (Gilbert's disease allowed)
- Creatinine clearance of at least 60 mL/min within 30 days before treatment
- Heart ejection fraction of 50% or higher within 30 days before treatment
- Pulmonary function tests (FEV1, FVC, DLCO) at 50% or higher of predicted or oxygen saturation above 92% on room air within 30 days before treatment
- Women of childbearing potential with negative pregnancy test within 30 days before treatment
- Agreement to use effective birth control or abstain from heterosexual activity during the study and for 6 months after last treatment dose
- Discontinuation of all previous intensive therapy 2 weeks before study start (low-dose or maintenance chemotherapy allowed up to 7 days before enrollment)
- Have a suitable matched or haploidentical donor for stem cell donation who meets donor evaluation and screening requirements
You will not qualify if you...
- Prior allogeneic stem cell transplant
- More than 3 prior intensive chemotherapy regimens aimed at remission
- Use of investigational agents or concurrent intensive chemotherapy or radiation within 2 weeks before conditioning (except allowed low-dose or maintenance chemotherapy)
- History of allergic reactions to similar compounds as study agents
- Uncontrolled illnesses including active infections requiring antibiotics
- Active cancers other than non-melanoma skin cancer, in situ cervical cancer, or prostate cancer under surveillance or previously treated curatively
- Medical, neurologic, or psychiatric conditions impairing compliance or increasing risk as judged by investigator
- Pregnant or breastfeeding women
- Any other condition that investigator judges unsafe for study participation
- Inability to comply with study procedures due to feasibility or logistics issues
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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