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New combo therapy aims to improve stem cell transplants for leukemia patients

NCT ID NCT00544466

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

75 people

The number who actually took part.

Started

Jul 2006

Expected to finish

Dec 2026

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

7 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: * 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.

acute lymphoblastic leukemia acute myeloid leukemia Congenital Abnormalities leukemia myelodysplastic syndrome Myelodysplastic Syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma

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.