1/Phase 1: Arm 1 Dose Escalation for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Lymphoma+5 More
Vysis LSI MYC Break Apart Rearrangement Probe Kit - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Background: Non-Hodgkin lymphomas are blood cancers that can be difficult to treat. They can also return after treatment. Examples include diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). More effective treatments are needed for these diseases. Objective: To test the safety of a study drug (VIP152) in combination with other drugs used to treat people with aggressive blood cancers. Eligibility: People aged 18 years or older diagnosed with DLBCL, PTCL, or related blood cancers. The cancers must have either not responded to treatment or returned after treatment. Design: Participants will undergo screening. They will have a physical exam with scans and blood and urine tests. They will have imaging scans and tests of their heart function. They may also provide a bone marrow aspiration or biopsy. Participants may provide a saliva sample for DNA testing. Participants will receive study treatment in cycles. Each cycle is 21 days. Participants will take two drugs by mouth at home once a day on days 1-10 of each cycle. On days 2 and 9 they will come to the clinic to receive VIP152. This drug will be administered through a small plastic tube with a needle placed in a vein. On day 11, participants will receive a fourth medication as an injection under the skin. They will rest and recover on days 12-21. Screening tests will be repeated periodically throughout the study period. Treatment will continue for up to 24 cycles. Participants will have follow-up visits for up to 5 years.

Eligible Conditions

  • Lymphoma
  • Lymphoid Malignancies
  • Non-Hodgkin's Lymphoma (NHL)
  • Malignancies, Hematologic

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: time from the date of study enrollment during therapy, after completion of therapy from initiation of therapy to first response q3, 4, 6 and 12 months for post-treatment years 1, 2, 3, and 4-5, respectively, for up to 5 years after the last participant

21 days
Adverse events
Month 6
Duration of Response (DOR)
Month 6
Progression-free survival (PFS)
Year 5
Time to Response (TTR)
Month 6
Overall survival (OS)
Month 6
Event-free survival (EFS)
Month 6
Overall Response Rate (ORR)
time measurement criteria are met for CR until the first date that progressive disease is objectively documented or death, assessed every 3-6months
Complete response (CR) rate

Trial Safety

Trial Design

2 Treatment Groups

1/Phase 1: Arm 1 Dose Escalation
1 of 2
2/Phase 2: Arm 2 Dose Expansion
1 of 2
Experimental Treatment

130 Total Participants · 2 Treatment Groups

Primary Treatment: 1/Phase 1: Arm 1 Dose Escalation · No Placebo Group · Phase 1 & 2

1/Phase 1: Arm 1 Dose EscalationExperimental Group · 4 Interventions: Vysis LSI MYC Break Apart Rearrangement Probe Kit, venetoclax, VIP152, prednisone · Intervention Types: Device, Drug, Drug, Drug
2/Phase 2: Arm 2 Dose ExpansionExperimental Group · 4 Interventions: Vysis LSI MYC Break Apart Rearrangement Probe Kit, venetoclax, VIP152, prednisone · Intervention Types: Device, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
venetoclax
2014
Completed Phase 3
~200
prednisone
1999
Completed Phase 3
~10920

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from the date of study enrollment during therapy, after completion of therapy from initiation of therapy to first response q3, 4, 6 and 12 months for post-treatment years 1, 2, 3, and 4-5, respectively, for up to 5 years after the last participant
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
2016First Recorded Clinical Trial
62 TrialsResearching Lymphoma
270 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have aggressive B-cell lymphoma that has relapsed after and/or refractory to at least 2 prior systemic therapies, 1 or more which includes an anthracycline and anti-CD20 targeting agent.
You have a poor performance status.
You have an absolute neutrophil count of at least 1,000/mcL.
You have a disease that is evaluable by clinical exam, laboratory assessment, and/or imaging.
You have a tumor that has been treated with radiation therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.