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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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My cancer has high-risk genetic features.
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My blood disorder is at an intermediate or high risk level, with less than 10% of blasts in my bone marrow.
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My kidney function is within the required range for the study.
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My lungs work well enough to get oxygen into my blood.
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My leukemia is in remission with 5% or fewer immature cells.
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I have a suitable donor for a transplant according to the University of Minnesota's criteria.
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I am under 21 with AML and my treatment hasn’t worked, but I have less than 25% cancer cells in my marrow.
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My lymphoma or leukemia is responding to the first treatment.
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My APL is in its first remission after initial treatment.
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My leukemia is considered high risk.
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I am under 21 with high-risk ALL and achieved complete remission after having M2/M3 marrow.
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I have CML and cannot tolerate or didn't respond to a specific cancer drug.
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My CLL/SLL, Marginal Zone, or Follicular Lymphoma has worsened within 12 months after partial or complete remission.
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I am 60 years old or younger.
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My liver tests are within normal limits.
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My heart functions well, with no severe heart failure or uncontrolled irregular heartbeat.
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I agree to use birth control during treatment.
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I am over 60 with AML in first remission or under 60 with AML not in favorable-risk first remission.
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My genetic tests show a normal karyotype with NPM1 mutation and no FLT-ITD mutation.
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My large cell NHL is in partial or complete remission, or I can't have a transplant.
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My multiple myeloma has specific features making me eligible for this study.
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My leukemia is in remission.
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My leukemia is in remission but still shows signs of cancer cells.
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I have a cancer that affects my natural killer cells.
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I am HIV positive with an undetectable viral load and have a management plan.
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I was diagnosed with my condition at 30 or older.
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My leukemia cells have a specific genetic change but no cKIT mutation.
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I still have signs of cancer after initial treatments.
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My blood disorder is considered high risk but with less than 10% immature blood cells.
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I have juvenile myelomonocytic leukemia.
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I have ALL/lymphoma in second or more remission, had issues with chemotherapy, or have high-risk ALL.
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My AML is considered to be at a favorable risk.
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I have a bone marrow failure syndrome that is not Fanconi Anemia or Dyskeratosis Congenita.
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My leukemia has spread to my brain or spinal cord.
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My genetic test shows a double mutation in CEBPA with a normal karyotype.
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My leukemia does not have a cKIT mutation but has specific chromosome changes.
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I am mostly active and can care for myself.
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I have Plasma Cell Leukemia and have partially improved after initial treatment.
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My high-grade lymphoma is in early remission or progressed after initial treatment.
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My organs are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Chronic GVHD - 1 year
Secondary outcome measures
Chronic GVHD - 2 years
Grade II-IV acute GVHD
Graft-versus-host disease-free, relapse free survival (GRFS)
+5 more

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
271 Previous Clinical Trials
14,325 Total Patients Enrolled
Shernan Holtan, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
1 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

HSCT with Non-TBI Regimen (Hematopoietic Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03314974 — Phase 2
Acute Myeloid Leukemia Clinical Trial 2023: HSCT with Non-TBI Regimen Highlights & Side Effects. Trial Name: NCT03314974 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the HSCT with TBI Regimen been officially sanctioned by the FDA?

"Our team at Power assessed the safety of Hematopoietic Stem Cell Transplantation with Total Body Irradiation as a 2, due to there being data in support of its security but not efficacy."

Answered by AI

Is the study currently recruiting participants?

"Clinicaltrials.gov affirms that this research project is currently recruiting participants, having first been listed on March 30th 2018 and most recently updated April 12th 2022."

Answered by AI

What is the uppermost limit of participants enrolled in this experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this trial, initially posted on March 30th 2018, is still actively seeking enrollees. 300 individuals must be recruited from a single location for the study to commence."

Answered by AI
~30 spots leftby Jan 2025