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Marrow Irradiation + Chemotherapy for Leukemia
Study Summary
This trial is testing the side effects and best dose of total marrow and lymphoid irradiation when given with fludarabine and melphalan before a donor stem cell transplant in people with high-risk acute leukemia or myelodysplastic syndrome.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I can understand and am willing to sign the consent form for the study.I am on low dose or maintenance chemotherapy like hydroxyurea or TKIs.I do not have any uncontrolled illnesses or infections.I haven't had experimental treatments or intense cancer therapy in the last 2 weeks.You have had allergic reactions to similar medicines or substances that are similar to the ones used in this study.I have no other cancers except for non-melanoma skin cancers.My cancer diagnosis is a type of blood cancer.I, as a donor, have health issues that prevent me from undergoing growth factor therapy or leukapheresis.You have another medical condition or a problem with your brain or emotions that would make it hard for you to follow the treatment plan or handle the transplant, or that would make it take longer for your blood to get back to normal.I have not had a bone marrow or stem cell transplant.I have had 3 or fewer intensive chemotherapy treatments to try to cure my cancer.I am a donor and have been approved for bone marrow donation because other methods may be risky for me.My AML is classified as high or intermediate risk, excluding FLT3-NPM1+.My condition is acute lymphocytic leukemia.My disease is currently active.My leukemia has specific genetic features or high white blood cell counts.I am mostly able to care for myself but may need help.I am on low dose chemotherapy or maintenance drugs like hydroxyurea or TKIs.My donor is a family member who partially matches my tissue type and no exact match is available.I have a sibling or an unrelated donor who matches me perfectly for a stem cell or bone marrow donation.I have not had radiation to my lung, liver, or kidney.My condition is a high-risk type of bone marrow disorder.I am between 12 and 55 years old and cannot undergo intense treatment due to other health issues.My kidneys are functioning well, with a creatinine clearance of 60 ml/min or more.My cancer responds well to chemotherapy.I have acute myelogenous leukemia.I stopped all intense cancer treatments 2 weeks ago.
- Group 1: Treatment (TMLI, fludarabine, melphalan)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is access to this research project open for participants?
"According to clinicaltrials.gov, this investigational trial is actively seeking out new participants and has been since July 6th 2018; its most recent update was on February 17th 2022."
How extensive is the participation in this medicinal experiment?
"Affirmative. The information on clinicaltrials.gov verifies that this experiment, which was initially publicized on July 6th 2018, is actively seeking participants. Approximately 36 people must be enlisted from a solitary medical centre."
What are the major indications for Total Marrow Irradiation treatment?
"Total Marrow Irradiation has been known to be successful in treating Hodgkin Disease, as well as other diseases such as Malignant Effusion, Mycosis Fungoides (MF), and Chronic lymphocytic leukemia (CLL)."
How hazardous is Total Marrow Irradiation for individuals?
"Given that this is a Phase 1 trial, meaning limited data exists to prove both efficacy and safety, Total Marrow Irradiation was given a score of 1."
Are there any other examples of Total Marrow Irradiation being studied in research?
"Currently, there are 387 Total Marrow Irradiation clinical trials in operation. 25 of these studies have entered their final stage (Phase 3). While Boston, Massachusetts is the main location for this type of research, it can be found at 4658 different medical sites across America."
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