Your session is about to expire
← Back to Search
Hematopoietic Stem Cell Transplantation
HSCT for Leukemia and Lymphoma
Phase 2
Recruiting
Led By Shernan Holtan, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1
Myeloproliferative Neoplasms/Myelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be <10% by bone marrow aspirate morphology.
Must not have
CML in blast crisis
if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to give an allogeneic HCT, which is a transplant of blood-forming cells from a donor. This new method uses a myeloablative preparative regimen, which is a way to kill cancer cells, followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen.
Who is the study for?
This trial is for people with various blood disorders like leukemia, lymphoma, and myelodysplasia who are in remission or have high-risk features. They must be under 60 years old with good organ function and HIV+ patients need an undetectable viral load. Pregnant women, those with active infections or certain types of cancer that aren't responding to treatment can't join.
What is being tested?
The study tests a bone marrow transplant (HSCT) using either total body irradiation (TBI) or a chemo regimen for those who can't have more radiation. It's followed by drugs to prevent graft-versus-host disease. The goal is to see how well these treatments work for severe blood disorders.
What are the potential side effects?
Possible side effects include damage to organs from radiation or chemotherapy, increased risk of infections due to immune suppression, reactions from the transplant itself, and complications related to medications used after the transplant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has high-risk genetic features.
Select...
My blood disorder is at an intermediate or high risk level, with less than 10% of blasts in my bone marrow.
Select...
My kidney function is within the required range for the study.
Select...
My lungs work well enough to get oxygen into my blood.
Select...
My APL is in its first remission after initial treatment.
Select...
I am under 21 with high-risk ALL and achieved complete remission after having M2/M3 marrow.
Select...
I have CML and cannot tolerate or didn't respond to a specific cancer drug.
Select...
I am 60 years old or younger.
Select...
My liver tests are within normal limits.
Select...
My heart functions well, with no severe heart failure or uncontrolled irregular heartbeat.
Select...
I am over 60 with AML in first remission or under 60 with AML not in favorable-risk first remission.
Select...
My genetic tests show a normal karyotype with NPM1 mutation and no FLT-ITD mutation.
Select...
My leukemia is in remission.
Select...
I have a cancer that affects my natural killer cells.
Select...
I am HIV positive with an undetectable viral load and have a management plan.
Select...
I was diagnosed with my condition at 30 or older.
Select...
My leukemia cells have a specific genetic change but no cKIT mutation.
Select...
I still have signs of cancer after initial treatments.
Select...
My blood disorder is considered high risk but with less than 10% immature blood cells.
Select...
I have juvenile myelomonocytic leukemia.
Select...
I have a bone marrow failure syndrome that is not Fanconi Anemia or Dyskeratosis Congenita.
Select...
My leukemia has spread to my brain or spinal cord.
Select...
My genetic test shows a double mutation in CEBPA with a normal karyotype.
Select...
My leukemia does not have a cKIT mutation but has specific chromosome changes.
Select...
I am mostly active and can care for myself.
Select...
I have Plasma Cell Leukemia and have partially improved after initial treatment.
Select...
My high-grade lymphoma is in early remission or progressed after initial treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My condition is chronic myeloid leukemia in its advanced stage.
Select...
I had a bone marrow transplant within the last 6 months if I'm under 18, or any type if I'm older.
Select...
My large cell/high grade NHL did not respond to 2 or more treatments.
Select...
I am not pregnant or breastfeeding and have a negative pregnancy test.
Select...
I have an active brain or spinal cord tumor.
Select...
I am HIV positive.
Select...
I currently have an infection that isn't under control.
Select...
My lymphoma is getting worse despite treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Chronic GVHD - 1 year
Secondary study objectives
Chronic GVHD - 2 years
Grade II-IV acute GVHD
Graft-versus-host disease-free, relapse free survival (GRFS)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: TBI RegimenExperimental Treatment1 Intervention
Group II: Non-TBI RegimenExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
279 Previous Clinical Trials
15,281 Total Patients Enrolled
Shernan Holtan, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
1 Previous Clinical Trials
53 Total Patients Enrolled
Punita Grover, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has high-risk genetic features.My blood disorder is at an intermediate or high risk level, with less than 10% of blasts in my bone marrow.My kidney function is within the required range for the study.My condition is chronic myeloid leukemia in its advanced stage.My scans show my cancer is getting worse, but PET scan activity alone doesn’t disqualify me.My lungs work well enough to get oxygen into my blood.My leukemia is in remission with 5% or fewer immature cells.I had a bone marrow transplant within the last 6 months if I'm under 18, or any type if I'm older.I have a suitable donor for a transplant according to the University of Minnesota's criteria.I'm sorry, but without specific details, I am unable to provide a simplified rewrite. If you could provide more information, I'd be happy to assist you further.My lymphoma or leukemia is responding to the first treatment.My large cell/high grade NHL did not respond to 2 or more treatments.My APL is in its first remission after initial treatment.My leukemia is considered high risk.Your white blood cell count is very high when you are diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) or T-cell acute lymphoblastic leukemia (T-ALL).Your bone marrow still has a lot of immature white blood cells after 14 days of treatment.I am under 21 with high-risk ALL and achieved complete remission after having M2/M3 marrow.I have CML and cannot tolerate or didn't respond to a specific cancer drug.I am not pregnant or breastfeeding and have a negative pregnancy test.I am 60 years old or younger.My liver tests are within normal limits.My heart functions well, with no severe heart failure or uncontrolled irregular heartbeat.I am over 60 with AML in first remission or under 60 with AML not in favorable-risk first remission.My genetic tests show a normal karyotype with NPM1 mutation and no FLT-ITD mutation.My large cell NHL is in partial or complete remission, or I can't have a transplant.My multiple myeloma has specific features making me eligible for this study.My leukemia is in remission.My leukemia is in remission but still shows signs of cancer cells.I am under 21 with AML and my treatment hasn’t worked, but I have less than 25% cancer cells in my marrow.My CLL/SLL, Marginal Zone, or Follicular Lymphoma has worsened within 12 months after partial or complete remission.I agree to use birth control during treatment.I have a cancer that affects my natural killer cells.I am HIV positive with an undetectable viral load and have a management plan.I was diagnosed with my condition at 30 or older.My leukemia cells have a specific genetic change but no cKIT mutation.I still have signs of cancer after initial treatments.My blood disorder is considered high risk but with less than 10% immature blood cells.I have juvenile myelomonocytic leukemia.I have ALL/lymphoma in second or more remission, had issues with chemotherapy, or have high-risk ALL.My AML is considered to be at a favorable risk.I have an active brain or spinal cord tumor.I have a bone marrow failure syndrome that is not Fanconi Anemia or Dyskeratosis Congenita.I am HIV positive.My leukemia has spread to my brain or spinal cord.My genetic test shows a double mutation in CEBPA with a normal karyotype.My leukemia does not have a cKIT mutation but has specific chromosome changes.I currently have an infection that isn't under control.I am mostly active and can care for myself.My lymphoma is getting worse despite treatment.I have Plasma Cell Leukemia and have partially improved after initial treatment.My high-grade lymphoma is in early remission or progressed after initial treatment.My organs are functioning well.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger