Precision radiation may boost stem cell transplant success in tough leukemias
NCT ID NCT02094794
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a precise radiation method called total marrow and lymphoid irradiation (TMLI) given with two chemotherapy drugs (etoposide and cyclophosphamide) before a donor stem cell transplant. The goal is to safely deliver higher radiation doses to the bone marrow to wipe out cancer cells while protecting nearby organs. The trial enrolls adults with high-risk acute lymphocytic or myeloid leukemia that has not responded to previous treatment.
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 and lymphoid irradiation (TMLI), cyclophosphamide, etoposide
- What this could lead to
- If successful, this approach could improve outcomes for patients with hard-to-treat leukemia by delivering higher radiation doses to the bone marrow while reducing side effects.
- What could go wrong
- This is a phase 2 trial, so results are still preliminary. The combination may still cause serious side effects, and it is not yet proven to be better than standard treatments.
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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108 people
The number who actually took part.
- Started
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May 2014
- 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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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: * Participant has the ability and the willingness to sign the informed consent document (for adults only, for participants with mild cognitive abilities may use a legally authorized representative) * Documented (signed) informed consent; 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 donor and recipient will be presented; alternative treatment modalities will be discussed; the risks are explained in detail in the enclosed consent forms * Karnofsky performance status \>= 70% =\< 2 * Acute lymphocytic leukemia or acute myelogenous leukemia who are not in first remission or second remission i.e. after failing induction therapy, or in relapse or beyond second remission; (prior therapy with VP-16 and Cytoxan is allowed) * All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical siblings who is willing to donate bone marrow or primed blood stem cells or a 10/10 allele matched unrelated donor; a single allele mismatch at A, B, C, DR or DQ and a killer immunoglobulin-like receptor (KIR) mismatch at C will be allowed; all ABO blood group combinations of the donor/recipient are acceptable * The time from the end last induction, re-induction, or consolidation regimen should be greater than or equal to 14 days from planned start of study treatment; Note: Chemotherapy given within 14 days of planned study enrollment for the purpose of controlling counts is permitted * Total bilirubin =\< 1.5 x upper limit of normal (ULN) OR 3 x ULN for Gilbert's disease * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 5 x ULN * Measured creatinine clearance \>= 80 ml/min per 24 hour urine collection OR serum creatinine =\< 1.3 mg/dL * Women of child bearing potential only: Negative urine or serum pregnancy test * Pulmonary function tests: Forced expiratory volume in one second (FEV1) and carbon monoxide diffusion capacity (DLCO) (adjusted for Hb) \>= 50% adjusted of predicted normal value * Echocardiogram (ECHO) or multi gated acquisition scan (MUGA): ejection fraction of \>= 50% AND no finding of abnormal wall motion (i.e. report does not indicate that wall motion is "abnormal" or "altered") * Electrocardiogram (EKG) showing no ischemic changes and no abnormal rhythm * Agreement of men AND women-of-child-bearing-potential 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 * DONOR ELIGIBILITY: Donor evaluation and eligibility will be assessed as per current City of Hope standard operating procedure (SOP) Exclusion Criteria: * Prior autologous or allogeneic hematopoietic stem cell * Prior radiation therapy that would exclude the use of TMLI * Plans during the trial to receive any other (non-trial) investigational agents, or concurrent biological, chemotherapy, or radiation therapy; (chemotherapy for white blood count control is permitted) * Uncontrolled illness including ongoing or active infection * History of allergic reactions attributed to compounds of similar chemical or biologic composition to etoposide * Patients with other active malignancies are ineligible for this study, other than localized malignancies * Patients with psychological or medical condition that patient's physician deems unacceptable to proceed to allogeneic hematopoietic stem cell transplantation * Women who are planning to become pregnant or breast feed during the trial * 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.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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