New transplant method aims to cut dangerous side effects in blood cancer patients
NCT ID NCT05565105
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special way to process donated stem cells to make transplants safer for people with leukemia or lymphoma. The goal is to reduce serious complications like graft-versus-host disease, where donor cells attack the patient's body. About 100 participants will receive a stem cell transplant using the CliniMACS system, which enriches healthy stem cells and removes immune cells that can cause harm. Researchers will track survival, disease relapse, and side effects to see if this approach improves outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Malignant conditions or other life-threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as: 1. AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16). 2. Secondary AML in 1st remission 3. AML in 1st relapse or 2nd remission 4. ALL/CLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission 5. CML failing to respond to or not tolerating imatinib or dasatinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis. 6. Non-Hodgkin's lymphoma with chemo responsive disease in any of the following categories: 1. Intermediate or high-grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants. 2. Any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant. 7. Chronic myelomonocyte leukemia: CMML-1 and CMML-2. The following inclusion criteria are also required: * Patient's age includes from ≥18 to ≤74 years old. * Patients may be of either gender or any ethnic background. * Patients must have a Karnofsky (adult) Performance Status of at least 70% * Patients must have adequate organ function measured by: Cardiac: asymptomatic or if symptomatic then LVEF at rest must be 50% and must improve with exercise. Hepatic: \< 3x ULN AST and: s 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g. AML Chloroma obstructing the biliary tree). Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval e.g. patients with PNH, Gilbert's disease or other hemolytic disorders. Renal: serum creatinine: s; 1.2 mg/dL or if serum creatinine is outside the normal range, then CrCl \> 30 ml/min (measured or calculated/estimated). Pulmonary: asymptomatic or if symptomatic, DLCO 50% of predicted (corrected for hemoglobin). Each patient must be willing to participate as a research subject and must sign an informed consent form. Exclusion Criteria: * Female patients who are pregnant or breast-feeding * Active viral, bacterial or fungal infection * Patient seropositive for HIV-I /II; HTLV -I /II * Presence of leukemia in the CNS
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baptist Health South Florida/Miami Cancer Institute
Miami, Florida, 33176, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Double-Drug attack on Hard-to-Treat lymphomas
- New drug takes aim at Treatment-Resistant leukemia
- Patient's own t cells engineered to hunt lymphoma in early trial
- The immune cells that could make stem cell transplants work better
- Blood cancer registry tracks thousands to map disease course