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Chemotherapy
Treatment (TMLI, fludarabine, melphalan, Orca-T) for Myelodysplastic Syndrome
Phase 1
Recruiting
Led By Amandeep Salhotra
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 for hemoglobin)
Age: 60-75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of therapy to relapse/progression, up to 2 years
Awards & highlights
Study Summary
This trial is testing a treatment for patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. The treatment involves using a targeted form of radiation therapy
Who is the study for?
This trial is for patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS). Participants must be eligible for stem cell transplant and have adequate organ function. Specific details on inclusion and exclusion criteria are not provided.Check my eligibility
What is being tested?
The trial tests a combination of targeted radiation therapy called total marrow lymphoid irradiation, chemotherapy drugs like fludarabine, melphalan, possibly thiotepa, and Orca-T cells—a type of engineered donor T-cell graft—to treat AML, ALL or MDS.See study design
What are the potential side effects?
Potential side effects may include damage to bone marrow, increased risk of infections due to low blood cell counts, reactions from the body against the donor cells (graft-versus-host disease), nausea from chemotherapy drugs, and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function tests are at least half of what is expected for someone my age and size.
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I am between 60 and 75 years old.
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I am able to care for myself but may not be able to do active work.
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My cancer diagnosis is confirmed and falls under specific blood cancer types.
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My kidney function test shows a creatinine clearance of 60 mL/min or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of therapy to relapse/progression, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of therapy to relapse/progression, up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Acute graft versus host disease (GVHD) of grades 2-4 and 3-4
Chronic Graft versus Host Disease rate
Incidence of adverse events
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (TMLI, fludarabine, melphalan, Orca-T)Experimental Treatment13 Interventions
PREPARATIVE REGIMEN: Patients undergo TMLI BID on days -8 to -5, followed by fludarabine IV on days -4 to -2 and melphalan IV on day -2. Patients receiving the lowest dose of TMLI also receive thiotepa IV on days -4 and -3.
HCT: Patients receive Orca-T CD34+HSPC and Treg products IV on day 0, followed by the Orca-T tcon product IV on day 2.
GVHD PROPHYLAXIS: Patients undergoing haplo-HCT receive tacrolimus starting on day 14 and continuing until day 90 with a taper per treating physician's discretion.
Patients also undergo ECHO or MUGA scans, DECT/MRI scans, bone marrow biopsies/aspirates, and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thiotepa
2008
Completed Phase 3
~2210
Echocardiography
2013
Completed Phase 4
~11670
Tacrolimus
2011
Completed Phase 4
~4740
Biospecimen Collection
2004
Completed Phase 2
~1700
Dual-Energy Computed Tomography
2018
N/A
~50
Fludarabine
2012
Completed Phase 3
~1100
Melphalan
2008
Completed Phase 3
~1500
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,627 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,668 Previous Clinical Trials
40,926,253 Total Patients Enrolled
Amandeep SalhotraPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
60 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit for the total number of individuals involved in this medical study?
"Indeed, according to the information available on clinicaltrials.gov, this trial is currently in the recruitment phase. The original posting of the trial was on March 28th, 2024, and it has been recently updated as of December 22nd, 2023. The study aims to enroll a total of 33 participants from one designated site."
Answered by AI
Are potential participants currently able to apply for enrollment in this ongoing clinical trial?
"Indeed, according to the details available on clinicaltrials.gov, this trial is currently actively seeking eligible participants. The initial posting of the study was dated March 28th, 2024 and the most recent update occurred on December 22nd, 2023."
Answered by AI
What is the level of safety associated with Treatment (TMLI, fludarabine, melphalan, Orca-T) when administered to patients?
"Due to the limited data supporting safety and efficacy in this Phase 1 trial, our team at Power rates the safety of Treatment (TMLI, fludarabine, melphalan, Orca-T) as a score of 1 on a scale from 1 to 3."
Answered by AI
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