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New radiation combo aims to boost stem cell transplant success in tough leukemia cases

NCT ID NCT00576979

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

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: * 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.

acute lymphoblastic leukemia acute myeloid leukemia leukemia 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.