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NCT06195891 · ClinicalTrials.gov registry record · Phase 1

Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.

Recruiting
Registry status
Phase 1
Development phase
33
Enrollment target
1
Study location

NCT06195891: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.

NCT06195891 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 33 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06195891, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by City of Hope Medical Center.

RECRUITING
Registry status
Phase 1
Development phase
33 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Will be scored on both the Bearman Scale and National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 scale.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Echocardiography
  • PROCEDURE Dual-Energy Computed Tomography

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2024-05-24
Est. Completion 2027-06-21
Phase Phase 1
City of Hope Medical Center

582 total trials

What NCT06195891 shows while recruiting

NCT06195891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower).

The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06195891 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06195891 about?

NCT06195891 is a clinical study titled "Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome". 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 myelo...

What is the current status of trial NCT06195891?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2024-05-24. Estimated completion is 2027-06-21.

What conditions does trial NCT06195891 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT06195891?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Echocardiography (PROCEDURE), Dual-Energy Computed Tomography (PROCEDURE).

Who is sponsoring clinical trial NCT06195891?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06195891 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06195891's enrollment target sits among peer trials

33 196th of 306 higher than 109 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06195891

Source: ClinicalTrials.gov NCT06195891, the US trial registry maintained by the National Library of Medicine. NCT06195891 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.