Could a smarter chemo schedule help kids beat cancer?

NCT ID NCT01760226

Disease control Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a chemotherapy regimen called DA-EPOCH-R in 4 children with certain B-cell cancers (DLBCL, PMBCL, or PTLD). The drugs are given as a continuous infusion over several days, and doses are adjusted based on how the child's body handles them. The goal was to see if this approach is safe and could improve cure rates while reducing side effects, as it has in adults.

What this could mean

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

Active substance: DA-EPOCH-R (a combination of rituximab, etoposide, vincristine, doxorubicin, cyclophosphamide, prednisone, and G-CSF)
What this could lead to: If this approach works in children, it could offer a safer and more effective treatment for certain B-cell cancers, potentially reducing side effects while maintaining high cure rates.
What could go wrong: This is a very early, small study with only 4 participants, so results may not apply to all children. The safety and effectiveness in children are still unknown, and there are risks from chemotherapy like infections and mouth sores.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

4 people

The number who actually took part.

Start date

Jan 2013

Finished

Dec 2016

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

Up to 30 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: * Patient with newly diagnosed, histologically confirmed, diffuse large B-cell lymphoma, or primary mediastinal B-cell lymphoma; or patient has post-transplant lymphoproliferative disorder regardless of when diagnosed. Exclusion Criteria: * Patient has received previous chemotherapy or radiation therapy in the three months prior to therapy, except for empiric initial intrathecal administration at diagnosis * Patient who has received any prior anthracyclines. * Patient with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction \<28%) NOT due to mediastinal mass. * Patient with severe renal disease (i.e. creatinine greater than 3 times normal for age; creatinine clearance less than 50 ml/min/1.73m2). * Patient with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST greater than 500 IU/L). * Patient with a Karnofsky performance score \<50% or Lansky score \<50%. * Patient has been documented HIV positive and is unwilling/unable to stop antiretroviral therapy * Female patient who is pregnant or breastfeeding. * Patient is of reproductive potential and is not willing to use an acceptable method of birth control * Patient has group classification A at diagnosis (completely resected stage I or completely resected stage II abdominal lesions) * Patient has group classification B stage I or II disease with normal LDH level AND tumor mass less than 7 cm * Patient has primary CNS lymphoma (lymphoma limited to the craniospinal axis without systemic involvement) * Patient has Burkitt lymphoma or leukemia

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma post-transplant lymphoproliferative disease primary mediastinal large B-cell lymphoma

As listed by the trial registrant

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

Diffuse large B-cell lymphoma Post-transplant lymphoproliferative disorder Primary mediastinal (thymic) large B-cell lymphoma

Could a smarter chemo schedule help kids beat cancer?

What the study statuses mean