Your session is about to expire
← Back to Search
Stem Cell Transplantation
2-Step Stem Cell Transplant for Blood Cancers
Phase 2
Waitlist Available
Led By Neal Flomenberg, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a Karnofsky performance score (KPS) >= 80%
Have a related donor who is no more than a 1-antigen mismatch at the human leukocyte antigen (HLA)-A; B; C; DR loci in the GVHD direction with the patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year post-hsct
Awards & highlights
Study Summary
This trial is testing a two-step stem cell transplant approach to treating blood cancers. The first step is chemotherapy and total body irradiation, followed by a transplant of healthy lymphocytes and stem cells from a donor. The trial will test how well this approach works and if it can help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Who is the study for?
This trial is for patients with blood cancers who have a heart function of at least 45%, lung capacity over half the expected, normal liver function, and kidney clearance above 60 mL/min. They need a closely matched related donor for stem cell transplant and must not be HIV positive or have another active cancer (except certain skin cancers). Women should use effective contraception, and men should abstain from sex during treatment.Check my eligibility
What is being tested?
The study tests a two-step stem cell transplant process to treat blood cancers. It involves chemotherapy, total body irradiation followed by white blood cell and stem cell transplants from donors in controlled doses to help rebuild healthy bone marrow while trying to prevent graft versus host disease using tacrolimus and mycophenolate mofetil.See study design
What are the potential side effects?
Possible side effects include reactions to the infusion like fever or chills, risk of infection due to immune suppression by medications such as tacrolimus and mycophenolate mofetil, potential damage to organs from radiation or chemotherapy, and graft versus host disease where the new cells attack the patient's own tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out normal activities with minimal assistance.
Select...
I have a donor who is almost a perfect match for my transplant.
Select...
I have a blood disorder that may benefit from a stem cell transplant.
Select...
My kidneys are functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year post-hematopoietic stem cell transplantation (hsct)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year post-hematopoietic stem cell transplantation (hsct)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Donor T cell chimerism
Incidence of grades II-IV graft versus host disease (GVHD)
Rate of treatment-related mortality (TRM)
+1 moreOther outcome measures
Rate of cytomegalovirus
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (TBI, DLI, chemotherapy, HSCT, tacrolimus, MMF)Experimental Treatment6 Interventions
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Mycophenolate mofetil
FDA approved
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Total-Body Irradiation
1997
Completed Phase 3
~1180
Donor Lymphocyte Infusion
1995
Completed Phase 2
~50
Tacrolimus
FDA approved
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,901 Total Patients Enrolled
Neal Flomenberg, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
14 Previous Clinical Trials
346 Total Patients Enrolled
USAMA GERGIS, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a donor able to give safe apheresis products without risking my health.I have a blood disorder that may benefit from a stem cell transplant.I have a donor who is almost a perfect match for my transplant.I have received specific immune treatments within 2 months before my transplant.I can carry out normal activities with minimal assistance.I have no other cancers besides skin cancer that needs only local treatment, or I have approval from the study leader.I agree to abstain from sexual activity during my treatment period.I am HIV positive.My kidneys are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (TBI, DLI, chemotherapy, HSCT, tacrolimus, MMF)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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.
How often do people face serious risks with Allogeneic Hematopoietic Stem Cell Transplantation?
"While there is some evidence of Allogeneic Hematopoietic Stem Cell Transplantation's safety, since this is only a Phase 2 trial, this procedure rates as a 2."
Answered by AI
For what medical reasons is Allogeneic Hematopoietic Stem Cell Transplantation most often leveraged?
"Dermatitis, atopic is usually treated with Allogeneic Hematopoietic Stem Cell Transplantation. This method of treatment can also be effective for other conditions including multiple sclerosis, leukemia, myelocytic, acute, and rejection; transplant, kidney."
Answered by AI
Are there any patients currently needed for this research?
"The clinical trial is currently looking for participants and has been since it was first posted on September 19th, 2018. The study was last updated on September 7th, 2022 and is enrolling 34 patients at a single location."
Answered by AI
What is the upper limit to recruitment for this clinical trial?
"According to the information available on clinicaltrials.gov, this study is still recruiting patients. The trial was originally posted on September 19th, 2018 and was last updated on September 7th, 2020. They are looking for a total of 34 participants at 1 site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger