New radiation combo aims to boost stem cell transplant success in tough leukemia cases
NCT ID NCT00576979
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to prepare patients with relapsed or hard-to-treat acute leukemia for a donor stem cell transplant. It combined a precise form of radiation therapy (IMRT) with two chemotherapy drugs (etoposide and cyclophosphamide) before the transplant. The goal was to find the safest radiation dose and see if this approach helps control the disease. Fifty-one patients took part in this early-phase trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intensity-modulated radiation therapy (IMRT) plus etoposide and cyclophosphamide
- What this could lead to
- If successful, this approach could improve the effectiveness of stem cell transplants for patients with relapsed or refractory leukemia, potentially leading to better long-term control of the disease.
- What could go wrong
- This is an early-phase trial with only 51 participants, so results may not apply to all patients. The combination of high-dose radiation and chemotherapy carries significant risks, including severe side effects and transplant 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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
51 people
The number who actually took part.
- Started
-
Mar 2008
- Finished
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Jan 2026
- 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
-
7 to 55 years
- Sex
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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 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: * Patients with acute lymphocytic leukemia or acute myelogenous leukemia who are not in first or second remission (i.e., after failing remission induction therapy or in relapse or beyond second remission) * All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical sibling 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 KIR mismatch at C will be allowed; all ABO blood group combinations of the donor/recipient are acceptable since even major ABO compatibilities can be dealt with by various techniques * Prior therapy with VP-16, Busulfan, and Cytoxan is allowed * 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 1.2 or creatinine clearance \> 80 ml/min * A bilirubin of less than or equal to 1.5 * Serum glutamic oxaloacetic transaminase (SGOT) less than 5 times the upper limit of normal * Serum glutamate pyruvate transaminase (SGPT) less than 5 times the upper limit of normal * Pulmonary functioning tests including diffusing capacity of carbon monoxide (DLCO) will be performed; forced expiratory volume in one second (FEV1) and DLCO should be greater than 50% of the predicted normal value * The time from the end last induction or reinduction attempt should be \>= 14 days * Signed informed consent form approved by the Institutional Review Board (IRB) is required DONOR: Any sibling donors who are histocompatible with the prospective recipient will be considered a suitable donor * Donors will be excluded if for psychological or medical reasons they are unable to tolerate the procedure * Donor should be able to donate peripheral blood stem cells or bone marrow Exclusion Criteria: * Prior radiation therapy that would exclude the use of total-body irradiation * Patients who have undergone bone marrow transplantation previously and who have relapsed * Patients with psychological or medical condition that patients physician deems unacceptable to proceed to allogeneic bone marrow transplant * Pregnancy * Electrocardiogram (EKG) showing ischemic changes or abnormal rhythm and/or an echocardiogram or MUGA scan showing abnormal wall motion or ejection fraction \< 50%
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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
-
City of Hope Medical Center
Duarte, California, 91010-3000, United States
More trials for these conditions
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?