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New treatment option for Acute Lymphoblastic Leukemia
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
ClinicalTrials.gov ID: NCT06195891
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Also referred to as Fluradosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- Documented informed consent of the participant
- Agreement to allow the use of archival tissue from diagnostic bone marrow biopsies
- If unavailable, exceptions may be granted with study primary investigator (PI) approval
- Age: 60-75 years
- Karnofsky performance status ≥ 70
You likely can't join if
- PATIENTS: Prior allogeneic stem cell transplant
- PATIENTS: More than 3 prior lines of intensive chemotherapy, where the regimen intent was to induce remission
- PATIENTS: Receiving any other investigational agents or concurrent biological, intensive chemotherapy or radiation therapy for the previous 2 weeks...
- PATIENTS: History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- PATIENTS: Having any uncontrolled illness including ongoing or active bacterial, viral or fungal infection requiring antibiotics
- PATIENTS: Patients with other active malignancies are ineligible for this study, other than non-melanoma skin cancer, in situ cervical cancer and...
See the full eligibility criteria
- Documented informed consent of the participant
- Agreement to allow the use of archival tissue from diagnostic bone marrow biopsies
- If unavailable, exceptions may be granted with study primary investigator (PI) approval
- Age: 60-75 years
- Karnofsky performance status ≥ 70
- Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories:
- Acute myelogenous leukemia:
- Patients with de novo or secondary disease in CR1 or more with European LeukemiaNet (ELN) intermediate or adverse risk category, or
- Patients with active disease
- Morphologically; or
- Minimal residual disease (MRD) + (flow cytometry of ≥ 0.1%, next generation sequencing [NGS] or cytogenetics)
- Acute lymphoblastic leukemia (ALL):
- Patients with de novo or secondary disease according to National Comprehensive Cancer Network (NCCN) guidelines for ALL hypoploidy (\< 44 chromosomes); t(v;11q23): MLL rearranged; t(9;22) (q34;q11.2); complex...
- Patients with active disease:
- Morphologically; or
- MRD+ (flow cytometry of ≥ 0.1%, or cytogenetics)
- Myelodysplastic syndrome in high-intermediate (int-2) and high risk categories per International Prognostic Scoring System Risk (IPSSR)
- Serum direct (conjugated) bilirubin ≤ 2.0 mg/dl performed within 30 days prior to day 1
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times the institutional upper limits of normal performed within 30 days prior to day 1. Patients with Gilberts disease...
- Creatinine clearance of ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula performed within 30 days prior to day 1
- Ejection fraction measured by echocardiogram or MUGA ≥ 50% performed within 30 days prior to day 1
- If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected...
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test performed within 30 days prior to day 1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be...
- 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...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- PATIENTS: Patients should have discontinued all previous intensive therapy, chemotherapy or radiotherapy for 2 weeks prior to commencing therapy on this study NOTE: Low dose chemotherapy or maintenance chemotherapy...
- DONORS: All candidates for this study must have an human leukocyte antigen (HLA) (A, B, C, and DR) identical sibling who is willing to donate mobilized peripheral blood stem cells or have a 10/10 (A, B, C, DR and DQ)...
- PATIENTS: Prior allogeneic stem cell transplant
- PATIENTS: More than 3 prior lines of intensive chemotherapy, where the regimen intent was to induce remission
- PATIENTS: Receiving any other investigational agents or concurrent biological, intensive chemotherapy or radiation therapy for the previous 2 weeks from conditioning NOTE: Low dose chemotherapy or maintenance...
- PATIENTS: History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- PATIENTS: Having any uncontrolled illness including ongoing or active bacterial, viral or fungal infection requiring antibiotics
- PATIENTS: Patients with other active malignancies are ineligible for this study, other than non-melanoma skin cancer, in situ cervical cancer and prostate cancer. Patients with prior history of localized prostate cancer...
- PATIENTS: The recipient has a medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong...
- PATIENTS: Females only: Pregnant or breastfeeding
- PATIENTS: 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
- PATIENTS: 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.