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New Two-Step transplant aims to cut deaths in blood cancer patients

NCT ID NCT05031897

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 63 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    RECRUITING

    Philadephia, Pennsylvania, 19107, United States

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