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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
9%
Insomnia
9%
Dry mouth
9%
Blood creatinine increased
9%
Abdominal pain
8%
Back pain
8%
Dysgeusia
7%
Oedema peripheral
7%
Dizziness
7%
Thrombocytopenia
7%
Headache
6%
Dehydration
6%
C-reactive protein increased
6%
Musculoskeletal pain
5%
Malaise
4%
Anxiety
4%
Pneumonia
3%
Rash
2%
Atrial fibrillation
2%
Accidental overdose
2%
Pleural effusion
1%
General physical health deterioration
1%
Disseminated intravascular coagulation
1%
Death
1%
Overdose
1%
Pneumothorax
1%
Sepsis
1%
Pericarditis
1%
Ascites
1%
Dysphagia
1%
Non-cardiac chest pain
1%
Bladder cancer
1%
Confusional state
1%
Pulmonary embolism
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat
Placebo

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
Prednisone
2014
Completed Phase 4
~2370
Vorinostat
2014
Completed Phase 3
~1600
Cyclophosphamide
1995
Completed Phase 3
~3780
Vincristine Sulfate
2005
Completed Phase 3
~10120
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,563 Total Patients Enrolled
Daniel O PerskyPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00972478 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Treatment (combination chemotherapy)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00972478 — Phase 1 & 2
Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00972478 — Phase 1 & 2

Frequently Asked Questions

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

Are there any vacancies in this experiment for volunteers?

"This trial has suspended its search for new candidates. It was initially put up on November 15th 2010 and last updated on the 16th of November 2022. If you are looking for other clinical trials, there is currently an abundance with 1782 studies searching for participants suffering from lymphoma or non-hodgkin's and 1528 research initiatives seeking volunteers to be administered Vorinostat."

Answered by AI

To what maladies does Vorinostat typically offer a therapeutic solution?

"For patients with pheochromocytomas, Vorinostat is a common therapeutic option. Additionally, this pharmacological treatment can be used to treat ulcerative colitis and multiple myeloma, as well as varicella-zoster virus acute retinal necrosis."

Answered by AI

How widely spread is the implementation of this research project?

"This trial is being conducted in 100 different medical centres, such as City of Hope Comprehensive Cancer Center (Duarte), Kalispell Regional Medical Center (Kalispell) and AdventHealth Hendersonville (Hendersonville)."

Answered by AI

Are there any other studies which have explored the potential of Vorinostat?

"Vorinostat first appeared on the medical scene in 1993 at National Institutes of Health Clinical Center. Since then, 3266 clinical trials have been conducted and there are currently 1528 active studies across several cities, with a particular focus on Duarte, California."

Answered by AI

How many enrollees are participating in this medical examination?

"At the present moment, this clinical trial is not taking on any new participants. The study was initially posted in November of 2010 and last updated in 16th of November 2022. If you're searching for alternatives, there are currently 1782 trials for lymphoma or non-hodgkin actively recruiting patients as well as 1528 studies with vorinostat accepting enrollees."

Answered by AI
~6 spots leftby Mar 2025