Clinical trial for Acute Myelogenous Leukemia
Official title Allo HSCT Using RIC and PTCy for Hematological Diseases
ClinicalTrials.gov ID: NCT05805605
What this study is testing
What is Peripheral Blood Stem Cell Transplant?
An investigational cellular therapy being studied as a potential treatment for acute myelogenous leukemia. It is designed to replace the patient's diseased bone marrow with healthy donor stem cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe and effective this transplant approach is for people with the listed blood cancers.
- Who it's for
- Adults who have one of the listed leukemias or lymphomas and are eligible for a donor stem‑cell transplant.
- What's involved
- Participants receive a mild chemotherapy and radiation preparation, then a stem‑cell infusion from a related or unrelated donor, followed by medication (cyclophosphamide, sirolimus, and mycophenolate) to prevent graft‑versus‑host disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 75
You may be able to join if
- Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\< 16 years).
- t(8,21) without cKIT mutation
- inv(16) or t(16;16) without cKIT mutation
- Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)
- Normal karyotype with double mutated CEBPA
You likely can't join if
- Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus.
- Untreated active infection
- Active central nervous system malignancy
- CML in blast crisis
- Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy.
- Less than 3 months since prior myeloablative transplant
See the full eligibility criteria
- Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\< 16 years).
- t(8,21) without cKIT mutation
- inv(16) or t(16;16) without cKIT mutation
- Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)
- Normal karyotype with double mutated CEBPA
- Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1
- 30 years of age or older at diagnosis
- White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis
- CNS leukemia involvement during the course of disease
- Slow cytologic response (\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)
- Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.
- Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
- Untreated active infection
- Active central nervous system malignancy
- CML in blast crisis
- Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.
- Less than 3 months since prior myeloablative transplant
- Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.