Can a gentler chemo-radiation combo make stem cell transplants safer for blood cancers?

NCT ID NCT03531736

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

17 people

The number who actually took part.

Started

May 2018

Expected to finish

May 2027

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: * 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

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

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