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Anti-metabolites
Stem Cell Transplant for Blood Cancers
Phase 2
Recruiting
Led By Filippo Milano
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Large cell lymphoma in > second CR (CR2)/ >= PR2
Myelodysplastic syndromes (MDS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1- and 2-years post-treatment
Awards & highlights
Study Summary
This trial is testing a donor stem cell transplant with chemotherapy and radiation to see if it can treat blood cancers.
Who is the study for?
This trial is for patients with various blood cancers who have responded poorly to other treatments or are in remission. They must be over 6 months old, have good heart and lung function, normal liver enzymes, acceptable kidney function, and a Karnofsky/Lansky score indicating they can carry out daily activities. Pregnant women and those with uncontrolled infections or hypersensitivity to the drugs used in the trial cannot participate.Check my eligibility
What is being tested?
The study tests if chemotherapy (treosulfan and fludarabine), total-body irradiation, followed by donor stem cell transplant is effective for treating blood cancers. The treatment aims to destroy cancer cells and make space for new stem cells from a donor that match the patient's immune system.See study design
What are the potential side effects?
Potential side effects include reactions related to immune suppression such as infection risk increase; organ damage due to intense chemotherapy; complications from radiation exposure; graft-versus-host disease where donated cells attack the body; nausea; fatigue; hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My large cell lymphoma is in its second or later remission.
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I have been diagnosed with myelodysplastic syndromes.
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My Hodgkin Lymphoma is in its third or later remission.
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My low grade lymphoma has worsened after two treatments but is now in partial or complete remission.
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My kidney function is within the required range.
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My high-grade lymphoma is responding to treatment.
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My CML is in the first phase and didn’t respond well to a specific cancer drug.
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I have been diagnosed with chronic myelomonocytic leukemia.
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My child can do most activities but may need help.
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My acute leukemia is in remission, with or without minimal signs of disease.
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My lungs are working well.
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I am a relative of the patient, 12 or older, weigh at least 40 Kg, and meet specific health criteria.
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I am mostly able to care for myself and carry out daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1- and 2-years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1- and 2-years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Graft failure/rejection
Secondary outcome measures
Acute graft versus host disease
Chronic graft versus host disease
Clinically significant infections
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (low dose treosulfan)Experimental Treatment9 Interventions
Patients receive low dose treosulfan IV over 120 minutes on days -6 to -4 and fludarabine IV over 60 minutes on days -6 to -2. Patients then undergo total-body irradiation and allogeneic hematopoietic stem cell transplantation, and receive cyclophosphamide, cyclosporine, mycophenolate sodium or mycophenolate mofetil, and filgrastim as in Arm A.
Group II: Arm A (high dose treosulfan)Experimental Treatment9 Interventions
Patients receive high dose treosulfan IV over 120 minutes on days -6 to -4 and fludarabine IV over 60 minutes on days -6 to -2. Patients then undergo total-body irradiation on day -1 and allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive cyclophosphamide IV over 1-2 hours on days 3-4. Beginning on day 5, patients receive cyclosporine IV BID or TID over 1-2 hours or PO (after 3 months, in the absence of GVHD, cyclosporine tapering will start by 5-10% per week, until drug withdrawal at 6 months post-transplant). Beginning on day 5, patients also receive mycophenolate sodium PO TID or mycophenolate mofetil IV or PO TID until day 35 (may be continued if active GVHD is present). Beginning on day 5, patients also receive filgrastim until the absolute neutrophil count is > 1,000/uL for 3 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Treosulfan
2009
Completed Phase 3
~2320
Total-Body Irradiation
1997
Completed Phase 3
~1180
Filgrastim
2000
Completed Phase 3
~3670
Cyclosporine
1997
Completed Phase 3
~1830
Fludarabine
2012
Completed Phase 3
~1100
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Mycophenolate Sodium
2017
Completed Phase 4
~40
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,185 Total Patients Enrolled
93 Trials studying Lymphoma
6,073 Patients Enrolled for Lymphoma
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,208 Total Patients Enrolled
100 Trials studying Lymphoma
6,477 Patients Enrolled for Lymphoma
medac GmbHIndustry Sponsor
38 Previous Clinical Trials
9,046 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer with a survival rate less than 75% in 5 years.My large cell lymphoma is in its second or later remission.My leukemia in the brain didn't respond to initial treatments.I am at least 6 months old.I have been diagnosed with myelodysplastic syndromes.My Hodgkin Lymphoma is in its third or later remission.My low grade lymphoma has worsened after two treatments but is now in partial or complete remission.I had a bone marrow transplant from a donor over 3 months ago, or I had graft failure.My kidney function is within the required range.You are allergic to treosulfan, fludarabine, or cyclophosphamide.My heart is functioning well.My DSA levels are below 5000 after treatment.My high-grade lymphoma is responding to treatment.My CML is in the first phase and didn’t respond well to a specific cancer drug.I have been diagnosed with chronic myelomonocytic leukemia.Your alkaline phosphatase levels are not more than 5 times the upper limit of normal.My child can do most activities but may need help.My acute leukemia is in remission, with or without minimal signs of disease.My lungs are working well.I am a relative of the patient, 12 or older, weigh at least 40 Kg, and meet specific health criteria.I am mostly able to care for myself and carry out daily activities.Your AST and ALT levels should be less than 2.5 times the upper limit of normal.Your bilirubin levels are not too high, unless you have a specific condition called Gilbert's disease or hemolysis.I do not have any severe infections that are currently untreated.My cancer is in partial or complete remission after initial treatment.My chosen donor matches me in CMV status and blood type as closely as possible.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (high dose treosulfan)
- Group 2: Arm B (low dose treosulfan)
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 is the FDA's stance on Allogeneic Hematopoietic Stem Cell Transplantation?
"Allogeneic Hematopoietic Stem Cell Transplantation is still in Phase 2, so there is only preliminary evidence for its safety."
Answered by AI
What is the primary reason that Allogeneic Hematopoietic Stem Cell Transplantation is employed?
"Allogeneic Hematopoietic Stem Cell Transplantation is the standard care for transplant patients. Additionally, this intervention can be used to treat disorders like multiple sclerosis and lupus nephritis."
Answered by AI
How many people are part of this experiment?
"The clinicaltrials.gov website verifies that this study is seeking patients. This trial was originally posted on January 25th, 2021 and updated as recently as October 26th, 2022. The investigators need to enroll 60 individuals at a single site."
Answered by AI
Are there other cases where Allogeneic Hematopoietic Stem Cell Transplantation has been studied?
"A total of 1105 studies are active that involve Allogeneic Hematopoietic Stem Cell Transplantation. Of these, 202 have reached Phase 3 testing. Most of the research taking place for Allogeneic Hematopoietic Stem Cell Transplantation is based in Philadelphia, Pennsylvania; however, there are a total of 31293 locations running trials for this treatment worldwide."
Answered by AI
Are patients being recruited for this research project at this time?
"Correct, the listing on clinicaltrials.gov says that this research project is open for recruitment. The study was first announced on January 25th 2021 and updated October 26th 2022. They are looking for 60 individuals total from 1 centre."
Answered by AI
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