What side effects are associated with this type of intervention?

Common treatments for Peripheral T-Cell Lymphoma, such as Belinostat and Pralatrexate, have notable side effects. Belinostat often causes nausea, fatigue, fever, anemia, and thrombocytopenia. Pralatrexate frequently results in mucositis, thrombocytopenia, neutropenia, and fatigue. Both treatments can lead to significant hematologic toxicities, necessitating careful monitoring and management.

What prior FDA approvals exist?

Belinostat (Beleodaq) is an FDA-approved Histone Deacetylase (HDAC) inhibitor for the treatment of relapsed or refractory Peripheral T-Cell Lymphoma (PTCL). Another HDAC inhibitor, Romidepsin (Istodax), is also approved for PTCL. Pralatrexate (Folotyn) is a Folate Analog Metabolic Inhibitor approved for the treatment of relapsed or refractory PTCL. These drugs offer targeted therapeutic options for patients with PTCL, focusing on different mechanisms to inhibit cancer cell growth.

What other types of research exist?

Promising novel alternatives for PTCL treatment in 2024 include Chidamide (another histone deacetylase inhibitor), Mogamulizumab (a monoclonal antibody targeting CCR4), and Brentuximab Vedotin (an antibody-drug conjugate targeting CD30). These therapies have shown efficacy in clinical trials and offer new mechanisms of action compared to Belinostat and Pralatrexate.

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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

Must not have

Adult T-cell lymphoma/leukemia

Primary cutaneous type ALCL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4.5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing two new drugs, Belinostat and Pralatrexate, combined with standard chemotherapy in patients with newly diagnosed PTCL. The goal is to find the safest and most effective dose. The new drugs work by either blocking cancer cell growth or tricking cancer cells into absorbing a harmful substance. Pralatrexate is a specially designed drug with greater preclinical antitumor activity than methotrexate.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have adult T-cell lymphoma/leukemia.

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My cancer is a type of lymphoma that affects the skin.

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I have been diagnosed with cutaneous T-cell lymphoma.

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My blood pressure is not controlled by medication.

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My cancer has spread to my brain.

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I have HIV, hepatitis B, or hepatitis C with an active infection.

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I have previously received HDAC inhibitor or pralatrexate therapy.

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I haven't used any experimental drugs or devices in the last 28 days and don't plan to during the study.

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I do not have serious heart issues or a history of certain heart conditions.

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I have T-cell prolymphocytic leukemia.

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I have precursor T-cell lymphoma or leukemia.

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I have been diagnosed with T-cell large granular lymphocytic leukemia.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFS

Secondary study objectives

Overall survival

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Belinostat, a Histone Deacetylase (HDAC) inhibitor, works by causing an accumulation of acetylated histones and proteins, leading to cell cycle arrest, differentiation, and apoptosis of cancer cells. Pralatrexate, a folate analog metabolic inhibitor, disrupts DNA synthesis by inhibiting dihydrofolate reductase, leading to cell death. These mechanisms are important for Peripheral T-Cell Lymphoma (PTCL) patients as they target the rapid proliferation and survival pathways of lymphoma cells, providing essential therapeutic options for a disease with often limited treatments.