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Histone Deacetylase Inhibitor

Belinostat/Pralatrexate + CHOP for T-Cell Lymphoma (CRESCENDO Trial)

Phase 3

Recruiting

Research Sponsored by Acrotech Biopharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Anaplastic lymphoma kinase (ALK)- negative anaplastic large-cell lymphoma (ALCL)

Peripheral T-cell lymphoma, not otherwise specified

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4.5 years

Awards & highlights

CRESCENDO Trial Summary

This trial is to find the best dose/treatment for newly diagnosed PTCL patients, comparing 2 experimental treatments & 1 active comparator to find Progression Free Survival.

Who is the study for?

This trial is for adults with newly diagnosed Peripheral T-cell Lymphoma (PTCL) who have not been treated before. They must be in good physical condition, with adequate blood counts and liver/kidney function. Patients should agree to use two forms of contraception and cannot participate if they have certain other lymphomas, uncontrolled conditions like high blood pressure or infections, are pregnant/breastfeeding, or have used experimental treatments recently.Check my eligibility

What is being tested?

The study tests the effectiveness of Belinostat or Pralatrexate when combined with CHOP/COP chemotherapy against CHOP alone in PTCL patients. It's a two-part study: first to find safe doses and then to compare how well each treatment prevents cancer progression over up to six cycles of therapy.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site, changes in blood counts that could lead to increased infection risk or bleeding problems, liver and kidney issues from the drugs' toxicity, fatigue, nausea, and possibly heart rhythm abnormalities.

CRESCENDO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is ALK-negative.

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My condition is peripheral T-cell lymphoma, not otherwise specified.

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I have been diagnosed with angioimmunoblastic T-cell lymphoma.

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I have been diagnosed with follicular T cell lymphoma.

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I have at least one tumor that can be measured.

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My cancer cells show CD30.

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My kidney function, measured by creatinine levels, is within the normal range.

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My condition is a specific type of T-cell lymphoma.

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My kidney function, measured by creatinine, is within normal limits.

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I can take care of myself and perform daily activities.

CRESCENDO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PFS

Secondary outcome measures

Overall survival

CRESCENDO Trial Design

5Treatment groups

Active Control

Group I: Group 2aActive Control2 Interventions

Group 2a Pralatrexate 20 mg/m2 + COP

Group II: Group 3Active Control1 Intervention

CHOP

Group III: Group 1aActive Control2 Interventions

Group 1a Belinostat 600 mg/m2 + CHOP

Group IV: Group 1bActive Control2 Interventions

Group 1b Belinostat 1000 mg/m2 + CHOP

Group V: Group 2bActive Control2 Interventions

Group 2b Pralatrexate 30 mg/m2 + COP

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acrotech Biopharma Inc.Lead Sponsor

30 Previous Clinical Trials

4,675 Total Patients Enrolled

Uma Srinivas Atmuri, MPharm, MSStudy DirectorAcrotech Biopharma Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Group 1b hazardous for those receiving treatment?

"Our team at Power have evaluated Group 1b's safety with a score of 3, indicating that there is solid evidence for effectiveness and multiple rounds of data backing its security."

Answered by AI

Are there any opportunities currently available to join this research experiment?

"As per the information provided on clinicaltrials.gov, this particular research project is now closed for enrollment after being posted in October of 2023 and last modified a few days later. However, 1731 other studies are still recruiting patients at this very moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

2023. "To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072131.