Intense Pre-Transplant combo shows promise for tough leukemias

NCT ID NCT00534430

Disease control Sponsor: City of Hope Medical Center Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a combination of intravenous busulfan, etoposide, and low-dose total-body irradiation before a donor stem cell or bone marrow transplant in 30 patients with advanced leukemia or myelodysplastic syndromes. The goal was to see how well this regimen controls the disease and its side effects. Researchers measured overall survival and disease-free survival at five years after transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: busulfan, etoposide, total-body irradiation, cyclosporine, mycophenolate mofetil
What this could lead to: If successful, this approach could improve long-term survival and reduce relapse for people with advanced blood cancers who need a donor stem cell transplant.
What could go wrong: This is a small, completed phase 2 trial, so results may not apply to all patients. The treatment involves high-dose chemo and radiation, which can cause serious side effects including organ damage and graft-versus-host disease.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Started

Feb 2000

Finished

Feb 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

16 to 50 years

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.

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Acute myeloid leukemia (AML) * Failed remission induction therapy or in relapse beyond second remission * In first remission with poor risk cytogenetics (e.g., 11q abnormalities, -7, -5, complex abnormalities \[i.e., \> 3 abnormalities, 6;9 translocation and 3q abnormalities del (7q), del (5q), complex abnormalities ≥ abnormalities, 9q, 20q, 21q, 17q, t(9;21)\]) * Acute lymphoblastic leukemia (ALL) * Failed remission induction therapy or in relapse beyond second remission * Blastic phase chronic myelogenous leukemia * Refractory anemia with excess blasts * Refractory anemia with excess blasts in transformation * HLA -A, -B, -C, -DR identical sibling donor match available * No relapse after prior bone marrow transplantation PATIENT CHARACTERISTICS: * Cardiac ejection fraction ≥ 50% * Serum creatinine ≤ 1.2 times upper limit of normal (ULN) or creatinine clearance \> 80 mL/min * Bilirubin ≤ 1.5 times ULN * AST and ALT \< 5 times ULN * FEV\_1 ≥ 50% of predicted normal * DLCO ≥ 50% of predicted normal * No psychological or medical condition that would preclude allogeneic transplantation (in the opinion of the treating physician) * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 28 days since prior induction or reinduction therapy * Prior etoposide and busulfan allowed * No prior radiation therapy that would exclude total-body irradiation

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia blast phase chronic myelogenous leukemia, BCR-ABL1 positive Congenital Abnormalities leukemia myelodysplastic syndrome myelodysplastic syndrome with excess blasts Myelodysplastic Syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma refractory anemia with excess blasts in transformation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia Myelodysplastic syndromes

More trials for these conditions

Other studies related to the condition(s) this trial covers.