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Could a custom chemo dose make stem cell transplants safer?

NCT ID NCT05540340

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tests a new way to calculate the dose of the chemotherapy drug melphalan for lymphoma patients about to receive a stem cell transplant. Instead of a fixed dose based on height and weight, researchers use a model that considers how previous patients processed the drug, aiming to give each person an optimal dose. The goal is to see if this personalized approach can reduce side effects while still being effective.

What this could mean

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

Active substance
melphalan
What this could lead to
If successful, this could lead to a safer, more personalized way to dose melphalan for lymphoma patients receiving a stem cell transplant, potentially reducing side effects while maintaining effectiveness.
What could go wrong
This is a very early phase 1 study with only 39 participants, so results may not apply to all patients. The personalized dosing method may not work as expected or could still cause significant side effects.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

39 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Sep 2027

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

18 to 70 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: * Age18 - 79 years old * Diagnosed with any type of lymphoma \[Hodgkin, non-Hodgkin (B- or T-cell)\] and planned for BEAM-AHCT * KPS \> 70 * Cardiac ejection fraction of \> 45% * Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45% * Creatinine clearance of ≥ 40 mL/min * Completion of most recent systemic therapy within 12 weeks of enrollment * Complete or partial response to systemic chemotherapy by IWG Working Group Criteria. * Total bilirubin \< 2.0 mg/dL in the absence of suspected Gilbert's disease (if Gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dL), and AST \& ALT \< 2.5 ULN. * Minimum stem cell dose of 2 x 10\*6 CD34+ cells/kg Exclusion Criteria: * Disease progression by IWG Working Group since last therapy * Pregnant or lactating females * Contraindication to CE melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim * Any known allergy or allergic reactions to Captisol * Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm B-cell non-Hodgkin lymphoma Hodgkins lymphoma lymphoma lymphoma, non-Hodgkin, familial non-Hodgkin lymphoma T-cell non-Hodgkin lymphoma

As listed by the trial registrant

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

Lymphoma Lymphoma, B-cell Lymphoma, Hodgkin Lymphoma, non-Hodgkin Lymphoma, T-cell

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

More trials for these conditions

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