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Radioactive Agent
Radioimmunotherapy + Chemotherapy for Leukemia
Phase 1
Recruiting
Led By Jeffrey Y Wong
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
Karnofsky performance status >= 70
Myelodysplastic syndrome in high-intermediate (int-2) and high-risk categories
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of therapy up to 2 years post-transplant
Awards & highlights
Study Summary
This trial is to find out if 90Y-DOTA-anti-CD25 basiliximab, given with fludarabine, melphalan, and total marrow and lymphoid irradiation, is an effective treatment for high-risk acute leukemia or myelodysplastic syndrome.
Who is the study for?
This trial is for adults with high-risk acute leukemia or myelodysplastic syndrome who are not candidates for intensive treatment due to age or comorbidities. Participants must have CD25 positive cancer cells, adequate organ function, and agree to birth control measures. Those with more than three prior treatments, uncontrolled infections, recent intensive therapies, or unable to comply with study procedures are excluded.Check my eligibility
What is being tested?
The trial tests a combination of the radioactive antibody 90Y-DOTA-anti-CD25 basiliximab with chemotherapy drugs fludarabine and melphalan, plus total marrow and lymphoid irradiation (TMLI). It aims to determine the best dose and assess potential benefits and side effects in preparation for stem cell transplantation.See study design
What are the potential side effects?
Potential side effects include reactions related to radiation exposure such as fatigue and nausea; immune responses from the monoclonal antibody; complications from chemotherapy like low blood counts leading to infection risk; organ inflammation; allergic reactions; and infertility risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
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My condition is a high-risk type of bone marrow disorder.
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My blood cancer diagnosis is confirmed and tests positive for CD25.
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My AML is classified as high or intermediate risk, except FLT3-NPM1+.
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My cancer is in remission but still shows minimal signs under detailed tests.
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My leukemia has specific genetic features or high white blood cell counts.
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My cancer is in remission but still shows signs of disease on a cellular level.
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I have acute myelogenous leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of therapy up to 2 years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of therapy up to 2 years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicity
Maximum tolerated dose/recommended phase II dose of 90Y-DOTA-antiradioimmunotherapy
Secondary outcome measures
Complete remission (CR) proportion at day +30
Event-free survival
Graft versus host disease and relapse free survival
+8 moreSide effects data
From 2019 Phase 2 trial • 77 Patients • NCT012515755%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (90Y-basiliximab, fludarabine, melphalan, TMLI)Experimental Treatment9 Interventions
Patients receive cold basiliximab IV, 111In-DOTA-anti-CD25 basiliximab IV, and 90Y-DOTA-anti-CD25 basiliximab IV on day -15. Patients also receive palifermin IV on days -11 to -9, fludarabine phosphate IV on days -4 to -2, melphalan IV on day -2, and undergo TMLI on days -8 to -5 in the absence of disease progression or unacceptable toxicity. Patients then undergo AHSCT on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Marrow Irradiation
2014
Completed Phase 1
~20
Total Lymphoid Irradiation
2008
Completed Phase 3
~160
Palifermin
2006
Completed Phase 3
~1200
Basiliximab
2006
Completed Phase 4
~4130
Melphalan
2008
Completed Phase 3
~1500
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,448 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,926,186 Total Patients Enrolled
Jeffrey Y WongPrincipal InvestigatorCity of Hope Medical Center
8 Previous Clinical Trials
213 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled illnesses or infections.I am able to care for myself but may not be able to do active work.I have had a stem cell transplant using my own or donor cells.My condition is a high-risk type of bone marrow disorder.My lung function tests are above 50% of what's expected.I have had 3 or fewer treatments aimed at curing my condition.I am 60 years or older, or I am 18-59 with health issues preventing intense treatment.My blood cancer diagnosis is confirmed and tests positive for CD25.I have acute lymphocytic leukemia.My cancer is in remission but still shows signs of disease on a cellular level.I am a donor and have been approved for bone marrow donation because other methods may be risky for me.I do not have any active cancer except for non-melanoma skin cancers.I stopped all strong cancer treatments 2 weeks ago, but may have taken low dose treatments recently.I have not had radiation to my lung, liver, or kidney.I, as a donor, cannot undergo growth factor therapy or leukapheresis due to health reasons.My AML is classified as high or intermediate risk, except FLT3-NPM1+.My cancer is in remission but still shows minimal signs under detailed tests.My cancer responds well to chemotherapy.I have acute myelogenous leukemia.You have experienced allergic reactions to similar medicines or substances like the study drug.I am not pregnant or breastfeeding.I am capable of having children and have not been surgically sterilized.My leukemia has specific genetic features or high white blood cell counts.I have not been on any experimental drugs or had intensive therapy in the last 2 weeks.You have a medical or mental health condition that could make it difficult for you to follow the treatment plan or recover from the transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (90Y-basiliximab, fludarabine, melphalan, TMLI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals able to enlist in this trial at present?
"According to the current information on clinicaltrials.gov, this study is actively enrolling participants. It was initially made available on July 15th 2024 and has been updated as recently as February 16th 2022."
Answered by AI
What medical conditions are usually treated with Allogeneic Hematopoietic Stem Cell Transplantation?
"Allogeneic Hematopoietic Stem Cell Transplantation has been demonstrated to be an effective form of treatment for stage i mycosis fungoides, polycythemia vera (PV), and other conditions exacerbated by immunosuppression."
Answered by AI
How many people are participating in the research at maximum capacity?
"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting participants that were initially posted on July 15th 2024 and was most recently modified on February 16th 2022. The research team requires the enrolment of 12 individuals from a single location."
Answered by AI
Could you please provide a summary of the Allogeneic Hematopoietic Stem Cell Transplantation research that has been conducted so far?
"Presently, 405 clinical trials researching Allogeneic Hematopoietic Stem Cell Transplantation are underway. Of those, 27 are in the final phase of testing. Although most of these studies are located near Ann Arbor, Michigan, 4657 sites across the world have taken part in this investigation into therapy."
Answered by AI
Has the FDA approved Allogeneic Hematopoietic Stem Cell Transplantation?
"Due to the limited existing data supporting both safety and efficacy, Allogeneic Hematopoietic Stem Cell Transplantation was given a score of 1 by our team."
Answered by AI
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