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Alkylating agents
Reduced-Intensity Conditioning for Blood Cancers
Phase 2
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate liver function as defined by a serum bilirubin =< 1.8, aspartate aminotransferase or alanine aminotransferase =< 2.5 x upper limit of normal
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is looking at whether a less intense conditioning regimen of radiation therapy and chemotherapy prior to a hematopoietic stem cell transplant reduces the rate of treatment-related mortality.
Who is the study for?
This trial is for patients with various blood cancers or disorders who have adequate lung, liver, heart function, and kidney clearance. They must not be HIV positive, pregnant, breastfeeding, or have another active malignancy or central nervous system involvement. Participants need a specific donor match and should meet certain health scores based on age.Check my eligibility
What is being tested?
The study tests if a less intense conditioning regimen before hematopoietic stem cell transplant can reduce treatment-related mortality in blood cancer patients. It involves lower doses of radiation and chemotherapy drugs like fludarabine and cyclophosphamide to prepare the body for the transplant.See study design
What are the potential side effects?
Potential side effects may include reactions to medications such as mycophenolate mofetil and tacrolimus (e.g., immune suppression), effects from total-body irradiation (e.g., fatigue, skin changes), plus typical chemotherapy side effects like nausea, hair loss, increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning well, based on recent blood tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-related mortality (TRM)
Secondary outcome measures
Development of relapsed disease
Engraftment
Immune reconstitution
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Radiation-Based Cohort (fludarabine, TBI, infusion)Experimental Treatment7 Interventions
Patients receive fludarabine IV on days -11, -10, -9, and -8, undergo TBI BID on days -10 and -9, undergo DLI on day -6, and receive cyclophosphamide IV on days -3 and -2. Patients begin tacrolimus and mycophenolate mofetil IV on day -1. Patients then undergo HSCT on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
Group II: Chemotherapy-Based Cohort (fludarabine, melphalan, TBI)Experimental Treatment8 Interventions
Patients receive fludarabine IV on days -11, -10, -9, and -8 and melphalan IV on days -10 and -9. Patients undergo TBI and DLI once on day -6. Patients receive cyclophosphamide IV on days -3 and -2 and begin tacrolimus and mycophenolate mofetil on day -1. Patients undergo hematopoietic stem cell transplant on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Tacrolimus
2011
Completed Phase 4
~4740
Cyclophosphamide
1995
Completed Phase 3
~3770
Total-Body Irradiation
1997
Completed Phase 3
~1180
Donor Lymphocyte Infusion
1995
Completed Phase 2
~50
Fludarabine
2012
Completed Phase 3
~1080
Melphalan
2008
Completed Phase 3
~1500
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
446 Previous Clinical Trials
147,890 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver is functioning well, based on recent blood tests.Your lung function is at least 50% of what it is expected to be for someone of your age and size.Your kidneys work well enough to filter at least 60 milliliters of waste from your blood every minute.I have a donor who is an exact match for my bone marrow transplant.I do not have any other cancer besides skin cancer that needs only local treatment.I have a blood-related cancer or condition and a partially matched donor.Your heart's pumping ability is at least 50%.You have HIV, cancer in the brain, or are pregnant or breastfeeding.I have a blood cancer or disorder and a partially matched donor for a transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation-Based Cohort (fludarabine, TBI, infusion)
- Group 2: Chemotherapy-Based Cohort (fludarabine, melphalan, TBI)
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.
Has Hematopoietic Cell Transplantation been researched in other studies?
"Currently, 1056 Hematopoietic Cell Transplantation trials are in progress with 192 reaching the Phase 3 stage. Of those studies, many are based near Philadelphia, PA but there are over 30k clinical trial sites offering these treatments worldwide."
Answered by AI
Has Hematopoietic Cell Transplantation been validated by the FDA?
"There is some evidence of the safety profile for Hematopoietic Cell Transplantation, so it has been given a score of 2."
Answered by AI
Is there a window of opportunity to join this scientific experiment?
"The clinical trial hosted on clinicaltrials.gov is actively seeking candidates, with its initial posting being the 25th of October 2021 and its most recent edit taking place on April 1st 2022."
Answered by AI
What conditions usually benefit from Hematopoietic Cell Transplantation?
"Hematopoietic Cell Transplantation has been authorised to treat a variety of medical conditions, such as dermatitis and atopic diseases, multiple sclerosis, acute myelocytic leukemia."
Answered by AI
What is the participant count for this clinical research endeavor?
"Affirmative. According to information provided on clinicaltrials.gov, this trial is actively looking for participants and was initially posted on October 25th 2021. It was last updated April 1st 2022 and requires 67 volunteers from a single medical centre."
Answered by AI
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