New radiation combo aims to make stem cell transplants safer for leukemia patients
NCT ID NCT03467386
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a precise radiation technique called total marrow/lymphoid irradiation (TMLI) combined with the chemotherapy drug cyclophosphamide for people with acute myeloid leukemia in remission. The goal is to see if this approach is safe and can help prepare the body for a donor stem cell transplant while reducing side effects. The study involves 56 participants and is currently on hold.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- total marrow/lymphoid irradiation and cyclophosphamide
- What this could lead to
- If successful, this approach could offer a more targeted and potentially safer way to prepare patients for a stem cell transplant, reducing side effects while controlling leukemia.
- What could go wrong
- This is a very early phase 1 pilot study with only 56 participants, so results are preliminary. The trial is currently suspended, and serious side effects including graft-versus-host disease and infection are possible.
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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56 people
The number who actually took part.
- Started
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Mar 2018
- Expected to finish
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Sep 2026
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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16 to 60 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: * This study is open to patients with acute myeloid leukemia (AML) evaluated within 30 days of the start of conditioning regimen and in first or second complete remission (CR) * Karnofsky performance status (KPS) \>= 70% * The effects of radiation on the developing fetus are known to be teratogenic; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately * Patients with acute myelogenous leukemia (AML) who are in first or second complete remission * All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical sibling who is willing to donate primed blood stem cells (preferred) or bone marrow, or have a 10/10 allele matched unrelated donor; all ABO blood group combinations of the donor/recipient are acceptable since even major ABO compatibilities can be dealt with by various techniques; (red cell exchange or plasma exchange) * A cardiac evaluation with an electrocardiogram showing no ischemic changes or abnormal rhythm and an ejection fraction of \>= 50% established by multi-gated acquisition scan (MUGA) or echocardiogram * Patients must have a serum creatinine of less than or equal to 1.3 mg/dL or creatinine clearance \> 70 ml/min as calculated by the Cockcroft-Gault formula * A bilirubin of less than or equal to 1.5 mg/dL, excluding patients with Gilbert's disease * Patients should also have a serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) less than 5 times the upper limit of normal * Pulmonary function tests including diffusing capacity of the lung for carbon monoxide (DLCO) will be performed; forced expiratory volume in 1 second (FEV 1) and DLCO should be greater than 50% of predicted normal value * All subjects must have the ability to understand and the willingness to sign a written informed consent; signed informed consent form approved by the Institutional Review Board (IRB) is required; the patient, family member, and transplant staff physician (physician, nurse, and social worker) meet at least once prior to starting the transplant procedure; during this meeting, all pertinent information with respect to risks and benefits to the donor and recipient will be presented; alternative treatment modalities will be discussed * The time from the end of last induction, re-induction, or consolidation regimen should be greater than or equal to 14 days * Prior therapy with etoposide and cyclophosphamide is allowed * DONOR: donor evaluation and eligibility will be assessed as per current City of Hope standard operating procedure (SOP) Exclusion Criteria: * Patients should not have any uncontrolled illness including ongoing or active or poorly controlled infection * Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy; maintenance therapy with Food and Drug Administration (FDA)-approved targeted therapies (e.g. tyrosine kinase inhibitors for Philadelphia chromosome \[Ph\] positive \[+\] acute lymphoblastic leukemia \[ALL\], and FLT inhibitors for FLT3+ patients) will be allowed after day 60 disease assessment * Prior radiation therapy that would exclude the use of TMLI * Relapsed patients who have undergone autologous or allogeneic hematopoietic stem cell transplantation previously * Patients with psychological or medical condition that patient's physician deems unacceptable to proceed to allogeneic hematopoietic stem cell transplantation * Electrocardiogram (EKG) showing ischemic changes or abnormal rhythm and/or an echocardiogram or MUGA scan showing abnormal wall motion or ejection fraction \< 50% * Patients who have been treated with chemotherapy or radiation for the purpose of induction, re-induction or consolidation, within two weeks of planned study enrollment * Patients with other active malignancies are ineligible for this study, other than localized malignancies * Patients that are pregnant or breastfeeding * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, including but not limited to, infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc. * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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City of Hope Medical Center
Duarte, California, 91010, United States
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Other studies related to the condition(s) this trial covers.
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- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?
- New drug combination targets Hard-to-Treat blood cancers