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Alkylating agents
Stem Cell Transplant after Chemotherapy and Radiation 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
Patients with refractory anemia (RA) or refractory anemia with ring sideroblasts (RARS) or isolated 5q-
Patients with refractory anemia with excess blasts (RAEB)-1, refractory cytopenia with multilineage dysplasia (RCMD)+/-ringed sideroblasts (RS), or myelodysplastic syndrome (MDS) not otherwise specified (NOS) with stable disease for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year post hsct
Awards & highlights
Study Summary
This trial uses reduced intensity chemotherapy and radiation therapy before a donor stem cell transplant to treat patients with hematologic malignancies.
Who is the study for?
This trial is for patients with various blood cancers or bone marrow disorders who have responded to initial treatments. They must have a partially matched related donor, good heart and lung function, normal liver enzymes, adequate kidney function, and agree to use contraception if needed. Excluded are those with other active cancers (except minor skin cancer), HIV positive individuals, certain performance status levels based on age, or anyone unable to consent.Check my eligibility
What is being tested?
The study tests whether lower doses of chemotherapy drugs like cyclophosphamide and fludarabine followed by radiation therapy can prepare patients for a stem cell transplant from a donor. The goal is to reduce cancer growth while minimizing rejection of the transplanted cells and side effects.See study design
What are the potential side effects?
Potential side effects include weakened immune system leading to increased infection risk; reactions from the body's acceptance of donor cells; possible damage to organs due to low-dose chemo/radiation; fatigue; nausea; mouth sores; hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have certain types of anemia called refractory anemia or refractory anemia with ring sideroblasts, or isolated 5q-.
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You have a specific type of myelodysplastic syndrome or related conditions and have had stable disease for at least 3 months.
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Patients with a specific type of advanced blood disorder who have responded well to chemotherapy.
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You have less than 5% of a specific type of cells in your bone marrow.
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You have a type of blood disorder called myeloproliferative disorder, except for chronic myelomonocytic leukemia (CMML).
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You have aplastic anemia.
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You have a blood or cancer disease that could be helped by a specific type of transplant, and the disease responds to chemotherapy.
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The patient must have a donor whose human leukocyte antigens (HLA) are different at 2, 3, or 4 specific locations, which may help prevent graft-versus-host disease.
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Your lung function test results show that your breathing is not severely limited.
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Your kidneys work well enough to clear at least 60 milliliters of creatinine from your body every minute.
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Patients with a health condition score or age score of 5 points or less are not eligible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year post hsct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year post hsct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Engraftment rates
Incidence and severity of GVHD
Lymphoid reconstitution
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: RIC HSCT, GVHD prophylaxisExperimental Treatment9 Interventions
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
2011
Completed Phase 4
~4740
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Mycophenolate mofetil
2014
Completed Phase 4
~2350
Total-Body Irradiation
1997
Completed Phase 3
~1180
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,876 Total Patients Enrolled
Neal Flomenberg, MDPrincipal InvestigatorThomas Jefferson University
14 Previous Clinical Trials
321 Total Patients Enrolled
Dolores Grosso, DNP, CRNPPrincipal InvestigatorThomas Jefferson University
8 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken alemtuzumab or antithymocyte globulin within 8 weeks before the transplant.You have HIV.You have aplastic anemia.You have a lower level of physical ability based on your age.You have certain types of anemia called refractory anemia or refractory anemia with ring sideroblasts, or isolated 5q-.You have cancer that has spread to your brain.You have a type of blood disorder called myeloproliferative disorder, except for chronic myelomonocytic leukemia (CMML).You have another type of cancer, except for a skin cancer that only needs treatment in the affected area.The patient must have a donor whose human leukocyte antigens (HLA) are different at 2, 3, or 4 specific locations, which may help prevent graft-versus-host disease.Patients with acute myeloid leukemia who have been in complete remission for at least 4 weeks and don't need treatment for their disease.Patients with a health condition score or age score of 5 points or less are not eligible.You have chronic myelomonocytic leukemia, unless you are in complete remission based on how the cells look under a microscope.You are not expected to live longer than 6 months due to reasons unrelated to your cancer or blood disorder.You had a type of leukemia called AML, but your blood tests showed that less than 10% of your blood cells were abnormal after treatment and for at least 8 weeks without needing more treatment.Your heart's left ventricular function is at least 45%.You have already received the first treatment for your illness.Your lung function test results show that your breathing is not severely limited.Your blood bilirubin level is less than or equal to 1.8.Your health condition and age score is higher than 5 points.You have a specific type of myelodysplastic syndrome or related conditions and have had stable disease for at least 3 months.Patients with a specific type of advanced blood disorder who have responded well to chemotherapy.You have Hodgkin or slow-growing non-Hodgkin's lymphoma.You have less than 5% of a specific type of cells in your bone marrow.You must have a high level of physical ability, measured by the Karnofsky performance status, to participate in the trial.You have a blood or cancer disease that could be helped by a specific type of transplant, and the disease responds to chemotherapy.Your liver enzymes (AST or ALT) are not more than 2.5 times the upper limit of normal.Your kidneys work well enough to clear at least 60 milliliters of creatinine from your body every minute.
Research Study Groups:
This trial has the following groups:- Group 1: RIC HSCT, GVHD prophylaxis
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.
What are some conditions that doctors often attempt to treat with Peripheral Blood Stem Cell Transplantation?
"Peripheral Blood Stem Cell Transplantation is sometimes used to ameliorate the symptoms of dermatitis atopic, as well as a host of other conditions like multiple sclerosis, leukemia, myelocytic, acute, rejection; transplant, kidney."
Answered by AI
Are subjects being actively sought for this research project?
"Yes, the trial is definitely still open as of now and you can find that information on clinicaltrials.gov. The study was posted on 11/13/2015 (November 13th, 2015) and was last updated recently on 6/13/2022 (June 13th, 2022). They are currently looking for 35 patients to fill up 1 spot at the location."
Answered by AI
What is the mortality rate for patients who receive Peripheral Blood Stem Cell Transplantation?
"While Phase 2 trials don't have data supporting efficacy, there is some safety evidence so Peripheral Blood Stem Cell Transplantation received a score of 2."
Answered by AI
Is Peripheral Blood Stem Cell Transplantation a common medical procedure?
"There are 1047 medical studies currently underway that involve Peripheral Blood Stem Cell Transplantation. Of these, 188 have progressed to Phase 3 clinical trials. The majority of the research teams conducting these trials are based in Philadelphia; however, there are 29617 locations across the globe where patients can receive this treatment."
Answered by AI
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