New combo therapy aims to improve stem cell transplants for leukemia patients
NCT ID NCT00544466
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new conditioning regimen using a precise type of radiation (helical tomotherapy) along with two chemotherapy drugs (fludarabine and melphalan) before a donor stem cell transplant. The goal is to reduce side effects and improve outcomes for people with leukemia or myelodysplastic syndromes. The trial enrolled 75 participants and is no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fludarabine phosphate, melphalan, and radiation therapy
- What this could lead to
- If successful, this approach could make stem cell transplants safer and more effective for people with blood cancers.
- What could go wrong
- This is an early-phase trial with only 75 participants, so results may not apply broadly. There are risks of serious side effects from the chemotherapy and radiation.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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75 people
The number who actually took part.
- Started
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Jul 2006
- Expected to finish
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Dec 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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7 years and older
- 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: * Recipient, or recipient's parents, or recipient's legal guardians must have signed a voluntary, informed consent in accordance with institutional and federal guidelines * Must have histopathologically confirmed diagnosis in one of the followed categories: * AML * MDS with intermediate or high-risk disease * ALL * Children and adults at any age with significant morbidity, as determined by the primary bone marrow transplant (BMT) doctor (MD), and approved by the principal investigator (PI) * Able to lie supine in a full body cast for approximately 30 minutes, the anticipated duration of each treatment session; for younger patients deep conscious sedation may be required * Performance status evaluated by Zubrod or Karnofsky (KPS) Performance Scales in patients \> 16 years or Lanksy Performance Scale in children =\< 16 years must have a score \>= 70% * Adequate cardiac function: cardiac ejection fraction \> 50% by multi gated acquisition scan (MUGA) scan and/or by echocardiogram * Adequate pulmonary function: adults (older than 16 years): diffusing capacity of carbon monoxide (DLCO) \> 50%; for young children in whom pulmonary function tests (PFT) are not applicable: assessment by a pediatrician or pulmonary consult * Adequate renal function as demonstrated by: creatinine clearance or glomerular filtration rate (GFR) \> 60 cc/min (24 hour urine collection) * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) =\< 5.0 times the institutional upper limits of normal * Patients must have less than 15% peripheral blasts * Pre-treatment tests must have been preformed within 30 days prior to initiation of high-dose chemotherapy * No other medical and/or psychosocial problems, which in the opinion of the primary physician or principle investigator would place the patient at unacceptable risk from this regimen Exclusion Criteria: * Patients with Acute Undifferentiated Leukemia (AUL), i.e. no lymphoid or myeloid markers * Previous radiation therapy to more than 20% of bone marrow containing areas, or to any area exceeding 2000 cGy * Patients with Fanconi Anemia * Major medical or psychiatric disorders that would seriously compromise patient tolerance of this regimen * Human immunodeficiency virus (HIV) infection * Evidence of Hepatitis B or C infection or evidence of cirrhosis * Uncontrolled viral, bacterial or fungal infection * Patients with recent (within 4 weeks) serious viral, fungal, or bacterial infection are excluded * Patients with radiographic changes indicating pulmonary disease, including but not limited to: pulmonary nodules, infiltrates, pleural effusion are excluded unless cleared by pulmonary biopsy showing no evidence for active pulmonary disease
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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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