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Stem Cell Transplant for High-Risk Solid Cancers in Youth
Study Summary
This trial is testing side effects and how well stem cell transplant after chemo works for kids and young adults with high-risk solid tumors.
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.Side effects data
From 2019 Phase 2 trial • 77 Patients • NCT01251575Trial Design
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Who is running the clinical trial?
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- I am pregnant, planning to become pregnant, or am nursing.My donor is a family member who matches me perfectly in 10 out of 10 HLA markers.You have a suitable donor for hematopoietic cell transplantation.My cancer responded well to chemotherapy, shrinking by 30% or more.I am on dialysis for kidney failure.I am HIV positive.I have a specific type of cancer that is either new or has come back.My donor's umbilical cord blood matches mine at least 4/6 for transplant.My donor's umbilical cord blood matches mine at least 4/6 for transplant.My kidneys work well enough, and I don't need dialysis.I need a machine to help me breathe.I do not have any worsening infections despite being on medication.My liver tests are within the required limits, except for high bilirubin due to Gilbert's syndrome.I have heart disease from birth causing heart failure.My lung function test shows I can breathe well enough, or my oxygen level is at least 92% without extra help.You do not have a suitable family member who can donate tissue for the study.My organs are too weak to handle a transplant and its preparation.
- Group 1: Treatment (conditioning regimen, HSCT)
- 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 currently opportunities to participate in this trial?
"Data found on clinicaltrials.gov affirms that this medical trial is recruiting participants at the moment. The study was listed initially on August 19th 2020 and its most recent edit occured September 22nd 2022."
To what health issues does Allogeneic Hematopoietic Stem Cell Transplantation lend itself as a potential remedy?
"Allogeneic Hematopoietic Stem Cell Transplantation can be an effective therapy for patients who are non-responsive to other treatments, suffer from vernal keratoconjunctivitis, or have adenocarcinoma."
What is the population size of this research endeavor?
"Affirmative, according to information on clinicaltrials.gov recruitment for this medical trial is currently underway. Initially published 8/19/2020 and most recently altered 9/22/2022, the study seeks 40 participants from a single site."
Has Allogeneic Hematopoietic Stem Cell Transplantation been tested as part of any other clinical trials?
"Currently, 870 active trials are examiing the potential of Allogeneic Hematopoietic Stem Cell Transplantation with 150 being in Phase 3. Moreover, 20613 clinical sites across the globe are running studies related to this topic; Philadelphia, Pennsylvania is home to several such tests."
Has Allogeneic Hematopoietic Stem Cell Transplantation been given authorization by the FDA?
"Allogeneic Hematopoietic Stem Cell Transplantation has been deemed to be of intermediate safety, scoring a 2 on our organisation's scale. This is due to its Phase 2 status, suggesting that while there are some data points supporting its safety profile, none exist in regards to efficacy."
What are the principal aims of this research endeavor?
"Evaluated over a month-long period, the primary objective of this medical trial is to assess grade III or higher organ toxicity from conditioning. Additional goals include measuring one year rates of chronic GVHD with competing risk analysis as outlined by Gooley, determining time until platelet and neutrophil engraftment using Kaplan and Meier's method, and calculating 100 day rates of acute graft versus host disease (aGVHD) with its own competing relapse rate according to Gooley's technique."
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