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Alkylating Agent

Vorinostat + Rituximab + Chemotherapy for Diffuse Large B-Cell Lymphoma

Phase 1 & 2

Waitlist Available

Led By Daniel O Persky

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must not have received prior chemotherapy, radiation, or antibody therapy for lymphoma; steroid pre-medication for IV contrast allergy is allowed

Patients must have Zubrod performance status of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of vorinostat when given with rituximab and chemotherapy to treat patients with newly diagnosed stage II-IV diffuse large B-cell lymphoma.

Who is the study for?

This trial is for adults with newly diagnosed stage II (bulky), III, or IV diffuse large B-cell lymphoma. Participants must have a certain level of physical fitness (Zubrod performance status 0-2) and adequate organ function as shown by blood tests. They should not be HIV positive, pregnant, or breastfeeding and must agree to use effective contraception. Prior cancer treatments are disallowed except for specific minor cases.

What is being tested?

The study is testing the combination of vorinostat with rituximab and chemotherapy drugs like cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone in treating advanced diffuse large B-cell lymphoma. It aims to find the best dose of vorinostat that's effective while monitoring how well this regimen works against cancer cells.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fever or chills; effects from cell death like nausea or fatigue; organ inflammation; increased risk of infection due to lowered white blood cell counts; heart issues from drug toxicity; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have not had chemotherapy, radiation, or antibody therapy for lymphoma.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I do not have HIV.

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I have a confirmed diagnosis of advanced DLBCL with a risk score above 0.

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My cancer can be measured and was checked by a CT or PET/CT scan within the last 28 days.

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My heart's pumping ability is normal, confirmed by a heart scan within the last 42 days.

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I haven't taken valproic acid in the last 28 days.

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I can provide a biopsy sample from my initial diagnosis for review.

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I am willing to stop taking any medications that may cause heart rhythm problems during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Progression-free Survival (Phase II)

Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)

Secondary study objectives

Overall Survival (Phase II)

Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)

Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL

Side effects data

From 2011 Phase 3 trial • 661 Patients • NCT00128102

57%

Nausea

47%

Fatigue

43%

Diarrhoea

40%

Decreased appetite

40%

Vomiting

29%

Dyspnoea

24%

Constipation

20%

Weight decreased

18%

Tumour pain

18%

Cough

15%

Pleural mesothelioma malignant advanced

14%

Anaemia

12%

Pyrexia

Insomnia

Dry mouth

Blood creatinine increased

Abdominal pain

Back pain

Dysgeusia

Oedema peripheral

Dizziness

Thrombocytopenia

Headache

C-reactive protein increased

Dehydration

Musculoskeletal pain

Malaise

Pneumonia

Anxiety

Rash

Atrial fibrillation

Accidental overdose

Pleural effusion

Overdose

Sepsis

Pneumothorax

Confusional state

Bladder cancer

General physical health deterioration

Non-cardiac chest pain

Pericarditis

Disseminated intravascular coagulation

Death

Ascites

Dysphagia

Pulmonary embolism

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Vorinostat

Placebo

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (combination chemotherapy)Experimental Treatment7 Interventions

Patients receive vorinostat PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860