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HSCT for Leukemia and Lymphoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
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."
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."
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."
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