New Two-Step transplant aims to cut deaths in blood cancer patients
NCT ID NCT05031897
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a two-step, lower-intensity transplant method for people with various blood cancers. The goal is to see if this gentler approach reduces the chance of dying from the transplant itself. About 63 participants will receive a combination of radiation, chemotherapy, and donor cells.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fludarabine, total-body irradiation, donor lymphocyte infusion, cyclophosphamide
- What this could lead to
- If successful, this could offer a safer transplant option for blood cancer patients, reducing the risk of death from treatment while still controlling the disease.
- What could go wrong
- This is a mid-stage trial with only 63 participants, so results may not apply to everyone. The approach may still carry risks of relapse or other complications.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 63 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Apr 2032
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: * Radiation-based cohort diagnoses: * Acute myeloid leukemia * Acute lymphoid leukemia in remission * Myelodysplasia (MDS) * Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement * Multiple myeloma * Chronic myeloid leukemia * Myelofibrosis * Myeloid malignancy not otherwise specified * Chronic myelomonocytic leukemia * Essential thrombocytopenia or polycythemia vera * T cell leukemia * T cell lymphoma without significant lymph node disease burden * Any hematological malignancy or dyscrasia not cited above in which HSCT is potentially curable * Any patient who has a hematological disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history. Examples are patients with previous treatment with radiation therapy precluding total-body irradiation (TBI), or a past history of myeloablative therapy, precluding a 2nd myeloablative regimen. * Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered) * Chemotherapy-based cohort diagnoses: * Hodgkin or non-Hodgkin lymphoma * Small lymphocytic lymphoma/CLL * Any other diagnosis in which chemotherapy is thought to be superior to radiotherapy for treatment of the disease * Hematological malignancy in patients who cannot receive \> 2 Gy radiation * Aplastic anemia and other non-malignant hematologic dyscrasias * Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered) * Human leukocyte antigen (HLA) identical cohort diagnoses: \* Patients in this group will be treated in parallel to the radiation-based cohort or the chemotherapy-based group based on what category their diagnosis falls into. However, these patients will have HLA identical related donors (one-antigen cross-over event included). * Left ventricular ejection fraction of \>= 50% * Diffusion lung capacity of oxygen \>= 50% and forced expiratory volume at 1 second \>= 50% of predicted corrected for hemoglobin * Serum bilirubin =\< 1.8 * Aspartate aminotransferase or alanine aminotransferase =\< 2.5 x upper limit of normal * Creatinine clearance of \>= 60 mL/min * Patients must have adequate Karnofsky performance status (KPS) and Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) scores: * Patients \< age 60 years must have a KPS of \>= 60% and an HCT-CI score of 5 or less * Patients aged 60 to 65 years must have a KPS of \>= 60% and an HCT-CI score of 4 or less * Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less * Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less * (Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator (PI) and at least 1 co-investigator (CI) not on the primary care team of the patient). This is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than guideline HCT-CI points. An example is a patient with a solid tumor malignancy in their remote history (adds 3 points to HCT-CI total) where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities * Patients must be willing to use contraception if they have childbearing potential * Patient or patient's guardian is able to give informed consent * Patients should have a life expectancy of \>= 6 months for reasons other than their underlying hematologic/oncologic disorder * Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol * Patients should not be: * Human immunodeficiency virus positive * Have active involvement of the central nervous system with malignancy. This can be documented by a normal neurological exam, magnetic resonance imaging (MRI) of the head, and/or a negative cerebral spinal fluid analysis * Pregnant or breastfeeding
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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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Sidney Kimmel Cancer Center at Thomas Jefferson University
RECRUITINGPhiladephia, Pennsylvania, 19107, United States
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- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas