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New drug may spare hodgkin patients from harsh chemo before transplant

NCT ID NCT01508312

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a targeted drug called brentuximab vedotin (SGN-35) could replace the standard ICE chemotherapy before a stem cell transplant in 66 people with relapsed or refractory Hodgkin lymphoma. The drug targets cancer cells and has fewer side effects than ICE. Patients whose PET scans showed no active disease after two cycles went straight to transplant, while others received additional ICE. The goal was to see if some patients could safely avoid the more toxic chemo.

What this could mean

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

Active substance
brentuximab vedotin (SGN-35)
What this could lead to
If successful, this could offer a less toxic way to prepare Hodgkin lymphoma patients for stem cell transplant, potentially avoiding harsh chemotherapy for some.
What could go wrong
This is a small, early-phase study (66 people) without a comparison group. The drug may not work for everyone, and some patients still need additional chemotherapy.

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 2

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

Participants

66 people

The number who actually took part.

Started

Jan 2012

Finished

Mar 2024

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

12 to 72 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: * Histologic diagnosis of cd30 positive classical Hodgkin's lymphoma. * Primary refractory or relapsed disease proven by biopsy or fine needle aspiration (cytology) of an involved site. Pathology must be reviewed at MSKCC. * Relapse or refractory disease following doxorubicin or nitrogen mustard containing front-line therapy * Fluorodeoxyglucose (FDG)-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by spiral CT, as assessed by the site radiologist. * Cardiac ejection fraction of greater than 45%, measured since last chemotherapy. * Hemoglobin-adjusted diffusing capacity for carbon monoxide of greater than 50% on pulmonary function testing, measured since last chemotherapy * Serum creatinine \< or = to 1.5 mg/dl; if creatinine \>1.5 mg/dl then the measured 12- or 24-hour creatinine clearance must be \>60 ml/minute. * ANC\>1000/μl and Platelets\>50,000/μl * Total bilirubin \< 2.0 mg/dl in the absence of a history of Gilbert's disease. * Females of childbearing age must be on an acceptable form of birth control. * Age between 12 and 72 * HIV I and II negative. Exclusion Criteria: * Received more than 1 prior treatment (combined modality therapy represents 1 treatment) for Hodgkin Lymphoma * Hepatitis B surface antigen positive or hepatitis B core antibody positive. * Known pregnancy or breast-feeding. * Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate. * Peripheral neuropathy \> grade 2

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Conditions

The condition(s) this trial relates to.

classic Hodgkin lymphoma Hodgkins lymphoma

As listed by the trial registrant

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

Hodgkin's lymphoma

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.