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Chemo/Radiation Therapy + Stem Cell Transplant for Myelofibrosis
Study Summary
This trial is testing a chemo/radiation therapy followed by a stem cell transplant to treat secondary myelofibrosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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 have severe liver issues with symptoms like bleeding, fluid buildup, or confusion.My donor is a relative who is not my mother and matches half of my HLA markers.I don't have specific antibodies against the donor's tissue, or they are low enough for safe transplant.I have had a transplant involving solid organ, stem cell, bone marrow, or blood.I have liver cirrhosis.My cancer has spread to my brain or spinal cord.I have had cancer before, but it has been in remission for at least 3 years, except for certain types like non-melanoma skin cancer.I am a donor without risk factors for complications from donation procedures.I am not pregnant or have not been breastfeeding for the last 6 months.I don't have a matching donor or need a transplant quickly without a matched donor.I am mostly active and over 50 with good mental function.My bone marrow test shows more than 15% blasts, or more than 5% if I previously had AML.I am HIV positive or have active hepatitis B or C.I have severe pulmonary hypertension confirmed by heart tests.I do not have any ongoing infections.I have taken JAK2 inhibitor therapy but can stop it 1-2 days before starting the new treatment.I am a donor with recent tests showing no HIV, HTLV, hepatitis B or C, and syphilis.I am not currently on any experimental drugs or undergoing chemotherapy, immunosuppression, or radiation.I, as a donor, have health issues that prevent me from undergoing growth factor therapy and leukapheresis safely.My kidneys are functioning well.My leukemia is in a controlled phase or I've achieved remission before a transplant.I do not have any active infections.I am over 50 and my health score for a specific condition is below 4.I currently have an active infection.My myelofibrosis is severe enough to need a transplant, according to DIPSS-plus.My donor is a half-match for me based on genetic testing.
- Group 1: Treatment (combination chemotherapy, TBI, HCT)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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
Are there any precedent studies utilizing Allogeneic Hematopoietic Stem Cell Transplantation?
"Currently, 1084 studies on Allogeneic Hematopoietic Stem Cell Transplantation are in progress with 200 trials reaching the late-stage of development. Whilst Philadelphia is a hub for this research, 31574 other medical centres across the globe are running related clinical trials."
What sort of results is this research aiming to achieve?
"The primary objective of this clinical trial, assessed over a window up to 100 days post-hematopoietic cell transplantation (HCT), is determining the occurrence of unacceptable toxicity. Secondary aims include platelet recovery defined as achieving a platelet count >= 20,000/uL without transfusion within 7 days; graft failure-free survival calculated using Kaplan-Meier product limit method and 95% confidence intervals; and cumulative incidence of relapse/progression estimated with Gooley et al.'s (1999) methodology."
What characteristics make someone a suitable candidate for this trial?
"This trial requires 16 participants, ranging from 18 to 65 years old, who have been diagnosed with secondary myelofibrosis. Additionally, patients that are at least 50 must possess a HCT-CI score lower than four and a Kranofsky performance rating of 70% or higher; cognitive capacity should be evaluated by either geriatrician/neurologists if deemed necessary. Moreover, these applicants need to lack an HLA matched donor or require prompt transplantation without one and also demonstrate LVEF scores above 50%. Furthermore, no active infections can be present for eligibility in this study."
How many people are being accepted into this clinical research study?
"Affirmative. According to the information presented on clinicaltrials.gov, this research project is actively recruiting participants and was initially listed on May 24th 2017 with a final update from August 15th 2022. The study requires 16 individuals at one medical centre for enrolment."
What medical ailment is Allogeneic Hematopoietic Stem Cell Transplantation most commonly prescribed for?
"Patients with atopic dermatitis, multiple sclerosis, and acute myelocytic leukemia can benefit from Allogeneic Hematopoietic Stem Cell Transplantation."
Is there any available capacity in this medical study for new participants?
"This clinical trial is currently in-progress, with the original post dating back to May 24th 2017 and a recent update on August 15th 2022. Data indicates that participants are still being accepted for this medical study."
Does the FDA currently recognize Allogeneic Hematopoietic Stem Cell Transplantation as a legitimate medical procedure?
"In this phase 1 trial, Allogeneic Hematopoietic Stem Cell Transplantation is judged to have a safety profile of level 1 due to the limited evidence available for its efficacy and security."
Is the enrollment criteria of this medical research limited to adults only?
"As per the prerequisites, only individuals between 18 and 65 can be included in this trial. For patients under 18 years of age, there are 402 other trials available whereas 1525 studies exist for those above 65."
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