Study Summary
This trial is testing whether adding a new drug to standard treatment can help people with leiomyosarcoma that has spread to other parts of the body.
- Unresectable or Metastatic Soft Tissue Sarcoma
- Leiomyosarcoma
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 15 Secondary · Reporting Duration: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Arm 1: Doxorubicin
1 of 2
Arm 2: L19TNF plus doxorubicin
1 of 2
Active Control
Experimental Treatment
114 Total Participants · 2 Treatment Groups
Primary Treatment: L19TNF plus doxorubicin · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 16 - 100 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are new patients being accepted into the trial currently?
"This clinical trial is actively recruiting patients, according to the listing on clinicaltrials.gov. The study was first posted on December 27, 2018 and was last edited on April 7, 2022." - Anonymous Online Contributor
Has this research been conducted before?
"Alfacell first sponsored a clinical trial for L19TNF plus doxorubicin in 1997. Since the initial study, which had 300 participants, there have been many more studies done to test this drug's efficacy. In total, 387 active trials are taking place across 67 countries and 1935 cities." - Anonymous Online Contributor
In how many different medical clinics is this research study being conducted today?
"This study is accepting patients at 10 different locations, including Mayo Clinic in Rochester, Minnesota, Mayo Clinic Hospital in Phoenix, Arizona, and Ohio State University Comprehensive Cancer Center in Columbus, Ohio." - Anonymous Online Contributor
Has the FDA cleared L19TNF in combination with doxorubicin for patient use?
"L19TNF plus doxorubicin is in Phase 2 of clinical trials, meaning that while there is safety data available, none currently exists to support efficacy. Our team rates it a 2 on our 1-3 scale." - Anonymous Online Contributor
Can octogenarians participate in this research project?
"Individuals that fall within the age bracket of 16 to 100 years old are able to apply for this clinical trial. Out of the 947 total trials, 252 are for minors and 695 are for adults over the age of 65." - Anonymous Online Contributor
Who can sign up to participate in this clinical trial?
"The eligibility requirements for this trial state that patients must have leiomyosarcoma and be between 16-100 years old. Right now, the investigators are looking to enroll 114 patients in total." - Anonymous Online Contributor
What are the primary conditions that L19TNF plus doxorubicin is designed to treat?
"The following cancerous conditions can be improved with L19TNF in conjunction with doxorubicin: lymphoma, hodgkins, carcinoma, bronchogenic, and neuroblastoma (nb)." - Anonymous Online Contributor
Are there previous cases of L19TNF being used in conjunction with doxorubicin?
"There are currently 387 L19TNF plus doxorubicin clinical trials underway. 121 of these active studies are in Phase 3 testing. Most of the research is conducted in New York, but there are 23777 locations running these sorts of experiments globally." - Anonymous Online Contributor