Completed

Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent Anaplastic Large Cell Lymphoma

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What is being tested

SGN-30 (anti-CD30 mAb)

Drug
Who is being recruted

Anaplastic Large-Cell Lymphoma

Over 18 Years
+26 Eligibility Criteria

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: December 18, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's Disease and anaplastic large cell lymphoma (ALCL). As of March 22, 2005, interim analysis of the Hodgkin's Disease (HD) arm has been completed per the statistical plan in the protocol. SG030-0003 is now closed to further recruitment of HD patients. 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: December 18, 2014
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
Anaplastic Large-Cell Lymphoma
Criteria
14 inclusion criteria required to participate
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

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12 exclusion criteria prevent from participating
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

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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