Can a gentler chemo-radiation combo make stem cell transplants safer for blood cancers?
NCT ID NCT03531736
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests a new, lower-intensity combination of chemotherapy and radiation before a donor stem cell transplant for people with high-risk blood cancers or aplastic anemia. The goal is to see if this approach is safe enough to allow the donor cells to take hold and cure the disease. The study uses a special method to remove certain immune cells from the donor graft, which may reduce complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of chemotherapy (fludarabine, cyclophosphamide), low-dose total body irradiation, antithymocyte globulin, rituximab, and a stem cell transplant from a donor with a special T-cell depletion process
- What this could lead to
- If this approach works, it could offer a safer, more effective way to cure certain blood cancers and aplastic anemia using donor stem cells.
- What could go wrong
- This is a very early pilot study with only 17 participants, so the results may not apply to everyone. The T-cell depletion method is not yet FDA-approved, and there are risks like infection, graft failure, or side effects from the conditioning regimen.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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17 people
The number who actually took part.
- Started
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May 2018
- Expected to finish
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May 2027
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 years and older
- 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: * Patients with one of the high risk myeloid diseases as outlined below. Patients must have ≤ 5% blasts on the last BM evaluation prior to starting the conditioning regimen. Diseases included on this protocol include: 1. Acute Myeloid Leukemia (AML) in CR1 with intermediate or high risk features as defined below: °Cytogenetic abnormalities which are not considered "good risk" cytogenetic features (i.e t(8:21), t(15:17), inv 16 without c-kit mutations. And/or * Therapy related AML with history of antineoplastic therapy (radiation and/or chemotherapy) And/or * Normal karyotype with mutations of FLT3, RUNX1, TP53 mutation, ASXL1 or any others that are considered to be high risk 2. AML in ≥ 2nd remission 3. Myelodysplastic syndrome, myeloproliferative neoplasms, or MDS/MPN overlap syndrome with: °International prognostic scoring system risk score INT-2 or high risk at the time of transplant evaluation. And/or * Any risk category if life-threatening cytopenia exists And/or * Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype. 4. Chronic myelomonocytic leukemia (CMML) 5. Chronic myeloid leukemia (CML) with the following features: °Patients who have failed or are intolerant to BCR-ABL tyrosine kinase inhibitors. And/or °CML with BCR-ABL mutation consistent with poor response to tyrosine kinase inhibition (e.g T351l mutation) 6. Patients with severe aplastic anemia * Chronic lymphocytic leukemia (CLL) with high risk disease as defined by the EBMT consensus criteria. * Non-Hodgkin lymphoma meeting both of the following criteria: * Responding to therapy prior to enrollment. * Relapse after prior autologous bone marrow transplant or are ineligible for autologous bone marrow transplant. * Multiple Myeloma with disease in the following categories: * Patients with relapsed multiple myeloma following autologous stem cell transplantation who have achieved at least partial response following additional chemotherapy * Patients with high risk cytogenetics at diagnosis must have achieved at least a partial response following autologous stem cell transplantation. Patients must have complex karyotype, del17p, t4;14, and/or t14;16 by FISH and/or del13 by karyotyping. * Each patient must be willing to participate as a research participant and must sign an informed consent form. * Organ Function and Performance Status Criteria: 1. Patients be ≥ 18 years old. 2. Patients must have a Karnofsky (adult) or Performance Status ≥ 70%. 3. Patients must have adequate organ function measured by: * Cardiac: asymptomatic or if symptomatic, then LVEF at rest must be ≥ 40% and must improve with exercise. * Hepatic: \< 5x ULN ALT and \< 2x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia. * Renal: CrCl \>30ml/min (measured or calculated/estimated). * Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin) Exclusion Criteria: * Prior allogenic hematopoietic stem cell transplantation * Prior radiation therapy with 400cGY or more of TBI * BM with increased fibrosis (Reticulin stain \> 1/3) * Active and uncontrolled infection at time of transplantation * HIV infection * Seropositivity for HTLV-1 * Inadequate performance status/ organ function * Pregnancy or breast feeding * Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests. Donor Inclusion and Exclusion Criteria: * Must be a 10/10 HLA genotypically match related or unrelated donor at all A, B, C, DRB1, and DQB1 loci, as tested by DNA analysis * Able to provide informed consent for the donation process per institutional standards * Meet standard criteria for donor collection as defined by the National Marrow Donor Program Guidelines
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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.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
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