L19TNF plus doxorubicin for Soft Tissue Sarcoma

Washington University, Saint Louis, MO
Soft Tissue Sarcoma+1 More ConditionsL19TNF plus doxorubicin - CombinationProduct
16 - 100
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Unresectable or Metastatic Soft Tissue Sarcoma
  • Leiomyosarcoma

Treatment 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.

Week 72
Duration of response (DOR)
Overall response rate (ORR)
Progression-free survival (PFS) rate
Week 23
Human anti-fusion protein antibodies (HAFA) levels against L19TNF.
Week 1
Area under the drug concentration-time curve, extrapolated to infinity [AUC].
Maximum drug concentration [Cmax].
Terminal half-life [t1/2].
Time to reach maximum drug concentration [Tmax].
Week 72
Progression free survival (PFS)
Week 144
Overall survival (OS) rates
Week 72
Echotomography, Computer
Week 144
Overall survival (OS)
Week 72
Number of Participants With Clinically Significant Abnormalities in Vital Signs (Systolic and Diastolic Blood Pressure, Temperature, Heart Rate).
Number of Participants With Clinically Significant Physical Examination Abnormalities (General Appearance, Skin, Eyes, Ears-Nose-Throat, Breast, Head and Neck, Lungs, Heart, Abdomen, Lymph Nodes, Musculoskeletal)
Number of patients with adverse events (AEs).
Percentage of participants with worst on-study hematological and chemistry abnormalities.

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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

Arm 2: L19TNF plus doxorubicin
Experimental Group · 1 Intervention: L19TNF plus doxorubicin · Intervention Types: CombinationProduct
Arm 1: Doxorubicin
ActiveComparator Group · 1 Intervention: Doxorubicin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

Philogen S.p.A.Lead Sponsor
36 Previous Clinical Trials
1,998 Total Patients Enrolled
Scott H. Okuno, M.D.Principal InvestigatorMayo Clinic, Rochester, MN

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.