Completed

A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Refractory or Recurrent Hodgkin's Disease or Anaplastic Large Cell Lymphoma

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What is being tested

Data Collection

Who is being recruted

Immune System Diseases
+7

+ Immunoproliferative Disorders
+ Lymphatic Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorSeagen Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

SGN-30 is the chimeric form of a novel murine monoclonal antibody (mAb), AC-10, that has specificity for CD30. The CD30 antigen has a very low expression on normal cells, but is expressed on malignant cells in Hodgkins disease and anaplastic large cell lymphoma. This study is designed to define the toxicity profile and antitumor activity of SGN-30 in patients with refractory or recurrent Hodgkin's disease and with refractory or recurrent anaplastic large cell lymphoma. Patients will receive 6 weekly intravenous (IV) infusions of SGN-30 followed by a 4 week observation period.

Official TitleA Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Refractory or Recurrent Hodgkin's Disease or Anaplastic Large Cell Lymphoma 
Principal SponsorSeagen Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
80 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Criteria

Inclusion Criteria: * Patients must have refractory or recurrent HD or refractory or recurrent ALCL. * Patients must have histologically confirmed CD30+ HD or ALCL. * Patients must have bidimensional measurable disease on physical examination or radiologic evaluation. * Patients must have failed systemic chemotherapy either as initial therapy for advanced disease or as salvage therapy after initial radiotherapy for early stage disease. * Patients may have received no more than four treatments (radiation, chemotherapy, and/or biologics) prior to enrollment. * Patients may have received no more than one stem cell transplantation. * Patients who have undergone stem cell transplantation must have received at least one therapy post-transplantation. Patients who have not had stem cell transplantation must be considered ineligible or refuse treatment by stem cell transplantation. * Patients must have completed radiotherapy and/or chemotherapy at least four weeks prior to enrollment. Any prior treatment with nitrogen mustard agents, melphalan, or BCNU must have been completed at least six weeks prior to enrollment. * Patients must have an ECOG performance status of ≤ 2 and a life expectancy \> three months. * Patients must be at least 18 years of age. * Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution. * Females of childbearing potential must have a negative β-HCG pregnancy test result within three days of enrollment. All patients must agree to use an effective contraceptive method during the course of the study. * Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart. * Patients must meet baseline lab data requirements. Exclusion Criteria: * Patients with primary cutaneous ALCL * Patients who have been treated previously with any anti-CD30 antibody * Patients who have received any mAb unless a recent serum testing reveals no antibody titer and no evidence of human anti-murine antibodies (HAMA) or human anti-chimeric antibodies (HACA) in the peripheral circulation * Patients receiving any investigational biological agent within eight weeks of enrollment or any other investigational agent within four weeks of enrollment * Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation * Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ * Patients with known active viral, bacterial, or systemic fungal infection; patients who are known to be HIV, Hepatitis B, or Hepatitis C positive. * Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias * Patients with symptomatic brain metastases requiring treatment * Patients who are pregnant or breastfeeding * Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment * Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 18 locations
Suspended
University of Alabama, BirminghamBirmingham, United StatesSee the location
Suspended
University of Califorinia at Los AngelesLos Angeles, United States
Suspended
Georgetown UniversityWashington, United States
Suspended
University of MiamiMiami, United States
Completed18 Study Centers