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Stem Cell Transplant + Chemotherapy for Leukemia and Lymphoma
Phase 1 & 2
Waitlist Available
Led By Maureen Ross
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a Karnofsky performance status score of > 50%
Left ventricular ejection fraction > 40%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is studying how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant.
Who is the study for?
This trial is for patients with various blood cancers or bone marrow disorders who have a compatible donor for stem cell transplant. They should be in certain disease states, like remission or very good partial response, and have adequate organ function. Participants must not be HIV positive, pregnant, nursing, or have severe myelofibrosis; they need to understand the study and agree to use birth control.Check my eligibility
What is being tested?
The trial tests if chemotherapy combined with total body irradiation and post-transplant cyclophosphamide can reduce graft versus host disease after a donor stem cell transplant. It includes drugs like fludarabine phosphate and melphalan hydrochloride that stop cancer cells from growing.See study design
What are the potential side effects?
Potential side effects include damage to organs due to chemotherapy and radiation, increased risk of infections from immune suppression, possible infertility due to treatment regimens, fatigue from anemia caused by bone marrow suppression, nausea/vomiting from chemo drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but cannot do normal activities or work.
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My heart pumps well, with an ejection fraction over 40%.
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My leukemia is in partial remission, or my multiple myeloma is responding well to treatment.
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I am approved to undergo a specific radiation dose before a transplant.
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My lymphoma is currently in complete remission.
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It's been over 2 weeks since my last radiation or surgery, and I've followed the required waiting period after my last chemotherapy.
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My bone marrow has less than 5% myeloblasts.
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I have a donor match for my transplant.
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I have severe aplastic anemia and if I have a mismatched donor, I've been treated with ATG.
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I had a bone marrow transplant over 6 months ago and it didn't work.
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I have been diagnosed with a specific type of blood cancer or severe aplastic anemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Extensive chronic graft versus host disease (GVHD)
Secondary outcome measures
Clinical response assessed as per bone marrow transplant (BMT) standard of care
Cumulative incidence of grade III-IV acute graft versus host disease (GVHD)
Cumulative incidence of relapse
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Prevention (chemotherapy, TBI, cyclophosphamide)Experimental Treatment8 Interventions
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Cyclophosphamide
1995
Completed Phase 3
~3770
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Sirolimus
2013
Completed Phase 4
~2750
Total-Body Irradiation
1997
Completed Phase 3
~1180
Melphalan Hydrochloride
2016
Completed Phase 2
~70
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,823 Total Patients Enrolled
Maureen RossPrincipal InvestigatorRoswell Park Cancer Institute
Christine HoPrincipal InvestigatorRoswell Park Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia is in partial remission, or my multiple myeloma is responding well to treatment.I am able to care for myself but cannot do normal activities or work.My heart pumps well, with an ejection fraction over 40%.Your lung function, measured by a test called DLCO, needs to be at least 40% of what is expected based on your hemoglobin levels and lung ventilation.Your doctor thinks you may have a hard time following the rules for stem cell transplantation due to serious mental health issues or difficult social circumstances.My lymphoma is currently in complete remission.I am HIV positive.Your SGOT or SGPT levels are not more than 3 times the upper limit of normal.Your bilirubin level is not more than three times the upper limit of normal.Your liver alkaline phosphatase levels are not more than three times the upper limit of normal.Your kidneys work well enough to filter out waste from your blood.It's been over 2 weeks since my last radiation or surgery, and I've followed the required waiting period after my last chemotherapy.My bone marrow has less than 5% myeloblasts.I was diagnosed with moderate to severe myelofibrosis less than 60 days ago.I have a donor match for my transplant.I am approved to undergo a specific radiation dose before a transplant.I do not have uncontrolled diabetes, heart disease, serious infections, or other conditions that would make treatment too risky.I have been diagnosed with a specific type of blood cancer or severe aplastic anemia.I am currently pregnant or breastfeeding.I have severe aplastic anemia and if I have a mismatched donor, I've been treated with ATG.I have antibodies against the transplant donor detected within the last 60 days.I had a bone marrow transplant over 6 months ago and it didn't work.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (chemotherapy, TBI, cyclophosphamide)
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 has been the outcome of prior studies regarding Allogeneic Hematopoietic Stem Cell Transplantation?
"As of now, 1085 clinical trials for Allogeneic Hematopoietic Stem Cell Transplantation are underway worldwide. Out of those 1085 studies, 194 have advanced to Phase 3 research and the majority (30901) are hosted in Philadelphia, Pennsylvania."
Answered by AI
What is the total enrollment capacity for this medical study?
"Yes, according to the details published on clinicaltrials.gov, this research endeavour is currently recruiting participants. It was initially announced on August 9th 2017 and last updated on May 2nd 2022; it aims to enroll 33 people at a single site."
Answered by AI
Is enrollment for this experiment still open?
"According to the clinicaltrials.gov database, this research trial is actively looking for participants. It was first published on August 9th 2017 and its latest update occurred in May 2nd 2022."
Answered by AI
In what medical circumstances is Allogeneic Hematopoietic Stem Cell Transplantation most frequently utilized?
"Allogeneic Hematopoietic Stem Cell Transplantation is a commonly used procedure to assist with organ transplants, as well as treating multiple sclerosis, acute leukemia and kidney transplant rejection."
Answered by AI
What criteria must potential participants meet to join this medical experiment?
"This clinical trial seeks 33 individuals who have been diagnosed with Waldenstrom macroglobulinemia, aged between 18 and 79. In addition to this condition, the study also welcomes patients afflicted with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukaemia (CLL) ,chronic myelogenous leukaemia(CML)(including those who are intolerant or unresponsive to tyrosine kinase inhibitors, accelerated phase and blast crisis history cases); Myelodysplastic syndrome (MDS); Non-Hodgkin's Lymphoma"
Answered by AI
Is this research accommodating geriatric patients?
"Participants in this medical trial must be aged between 18 and 79."
Answered by AI
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