Hematology
PHASE2
● Phase II
Phase I/II trial tests IMRT with chemotherapy before transplant for relapsed/refractory ALL/AML
ClinicalTrials.gov
Published March 30, 2026
City of Hope Medical Center
NCT00576979 ↗
A phase I/II clinical trial record describes a study investigating a conditioning regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). The study enrolled 51 patients with induction failure or relapse. The intervention involved intensity-modulated radiation therapy (IMRT) using helical tomotherapy, followed by intravenous cyclophosphamide and etoposide (VP-16), and then HSCT from an HLA-identical sibling or unrelated donor. No comparator was reported.
The primary outcome for the phase I portion was to determine the maximum tolerated dose of IMRT. Secondary outcomes included toxicity assessment, radiation dose to normal organs and bone marrow, and, for the phase II portion, overall survival, disease-free survival, and relapse rate. No results for any outcomes—including efficacy, safety, or tolerability—are reported in the provided trial record.
Key limitations stem from the nature of the evidence: this is a trial record without reported results. The study is in early phases (I/II), focusing on dose-finding and preliminary assessment. Safety and tolerability data are not available. The lead sponsor is the City of Hope Medical Center.
Practice relevance is currently absent due to the lack of reported data. This regimen remains entirely investigational. Clinicians should await peer-reviewed publication of results before drawing any conclusions about the feasibility, safety, or potential efficacy of this approach.
When leukemia comes back or doesn't respond to treatment, a stem cell transplant can be a last hope. But the powerful, whole-body radiation used to prepare the body for the transplant can cause serious, lasting damage to the heart, lungs, and other organs. Doctors are now asking if they can use a more precise, targeted form of radiation—called intensity-modulated radiation therapy, or IMRT—to focus the dose on the bone marrow while better shielding healthy tissues.
This trial enrolled 51 patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). The goal of the first phase was to find the highest dose of this targeted radiation that patients could tolerate when given alongside two chemotherapy drugs, before receiving a donor's stem cells. The second phase aimed to get an early look at whether this approach might help patients survive longer without their cancer returning.
It's crucial to understand this is just a record of the trial's plan. No results on side effects, survival, or the best dose have been reported yet. This is the earliest stage of research, designed to answer basic questions about safety and feasibility. The work is being led by the City of Hope Medical Center, and while the idea of a gentler preparation for transplant is compelling, we are years away from knowing if it truly works.
What this means for you: An early trial is testing a gentler radiation technique before stem cell transplant for aggressive leukemia. Results are not yet in.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE1/PHASE2
Condition(s): Leukemia
Intervention(s): cyclophosphamide (DRUG), etoposide (DRUG), allogeneic bone marrow transplantation (PROCEDURE), allogeneic hematopoietic stem cell transplantation (PROCEDURE), peripheral blood stem cell transplantation (PROCEDURE)
RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as etoposide and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving IMRT together with chemotherapy before transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy (IMRT) when given together with etoposide and cyclophosphamide followed by donor stem cell transplant and to see how well they work in treating patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Detailed: OBJECTIVES: I. To establish the maximum tolerated dose \[MTD\] of large field image-guided IMRT, using helical tomotherapy when given in combination with intravenous cyclophosphamide and VP-16 as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) from an human leukocyte antigen (HLA)-identical sibling or unrelated donor in patients with ALL or AML with induction failure or in relapse. (Phase I) II. To describe the toxicity at each dose level standard. (Phase I) III. To collect data on the radiation dose to normal organs and bone marrow using tomotherapy targeted total-body irradiation (TBI). (Phase I) IV. To estimate the overall survival probability, disease free survival probability and relapse rate associated with this regimen. (Phase II) V. To characteri
Primary Outcome(s): Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I)
Enrollment: 51 (ACTUAL)
Lead Sponsor: City of Hope Medical Center
Start: 2008-03-04 | Primary Completion: 2016-05-30
Results posted: 2023-04-11
