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Alkylating agents

Combination Chemotherapy for Diffuse Large B-Cell Lymphoma

Phase 1
Recruiting
Led By Ida C Wong-Sefidan
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
Participants must have histologically documented CD20 positive or negative diffuse large B-cell lymphoma (DLBCL)
Tissue available from the diagnostic biopsy in the form of blocks, tissue cores, or slides available for submission to central pathology is required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of ibrutinib when given with other cancer treatments to patients with HIV-positive stage II-IV diffuse large B-cell lymphomas.

Who is the study for?
This trial is for HIV-positive adults with stage II-IV diffuse large B-cell lymphomas who haven't had prior chemotherapy or radiotherapy for this condition. They must have a certain level of physical fitness, adequate organ function, and agree to use contraception. Those with severe illnesses, recent major surgery, other active cancers, or known brain metastases are excluded.Check my eligibility
What is being tested?
The trial tests the best dose and side effects of combining ibrutinib with rituximab and standard chemotherapy drugs (etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride) in treating patients. It aims to find out if this combination is more effective for those with HIV-associated lymphoma.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression such as infections; heart problems; liver issues indicated by changes in blood tests; allergic reactions; fatigue; nausea; hair loss from chemotherapy drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymphoma is confirmed to be DLBCL type, regardless of CD20 status.
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I can provide tissue samples from my biopsy for testing.
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I am not taking medications that strongly affect my liver enzyme levels.
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function, measured by creatinine levels or clearance, is normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Maximum tolerated dose (MTD) of ibrutinib in combination with chemotherapy
Recommended phase II dose (RP2D) of ibrutinib in combination with chemotherapy
Secondary outcome measures
Average number of days per cycle participants are able to stay on planned dose of ibrutinib
Receptors, Complement 3d
Changes in the levels of human immunodeficiency virus (HIV)-1 viral reservoirs
+11 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (R-da-EPOCH)Experimental Treatment11 Interventions
Patients receive rituximab IV on day 1 (for CD20 positive patients only), etoposide IV over 96 hours on days 1-4, doxorubicin hydrochloride IV over 96 hours on days 1-4, vincristine sulfate IV over 96 hours on days 1-4, prednisone PO daily on days 1-5, cyclophosphamide IV over 1 hour on day 5, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC from 1 calendar day up to 48 hours or filgrastim SC beginning on day 6 for up to 10 days until ANC is satisfactory.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Filgrastim
2000
Completed Phase 3
~3670
Cyclophosphamide
1995
Completed Phase 3
~3770
Ibrutinib
2014
Completed Phase 3
~1880
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Pegfilgrastim
2013
Completed Phase 3
~4410
Prednisone
2014
Completed Phase 4
~2370
Etoposide
2010
Completed Phase 3
~2440
Vincristine Sulfate
2005
Completed Phase 3
~10110

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,280 Total Patients Enrolled
Ida C Wong-SefidanPrincipal InvestigatorAIDS Malignancy Consortium

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03220022 — Phase 1
Diffuse Large B-Cell Lymphoma Research Study Groups: Treatment (R-da-EPOCH)
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03220022 — Phase 1
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03220022 — Phase 1

Frequently Asked Questions

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

What other research initiatives have been conducted surrounding pharmacological studies?

"The first pharmacological study of its kind began in 1993 at the NIH Clinical Center, and since then 3753 trials have been completed. At present, there are 1828 active studies occurring mainly out of Seattle, Washington."

Answered by AI

Are there numerous facilities conducting this research trial within the borders of this state?

"As part of this medical trial, patients can be enrolled at the Virginia Mason Medical Centre in Seattle, Washington; Pennsylvania Hospital in Philadelphia, Pennsylvania; Siteman Cancer Centre at Washington University in St. Louis Missouri and 16 other sites around the country."

Answered by AI

Has enrollment for this research commenced?

"Supporting the active recruitment of patients, clinicaltrials.gov documents that this medical trial was initially shared on November 3rd 2017 and its most recent update was from November 2nd 2022."

Answered by AI

What condition or illness is Pharmacological Study most commonly employed to combat?

"Pharmacological Study is most commonly employed to treat prostate cancer; however, it can also be utilized for a variety of other medical conditions such as pheochromocytomas, ulcerative colitis and varicella-zoster virus acute retinal necrosis."

Answered by AI

What is the primary purpose of this clinical research endeavor?

"This clinical trial will evaluate the Recommended Phase II Dose (RP2D) of ibrutinib in combination with chemotherapy, over a 21 day duration. To assess its efficacy, Complete Response Rates and respective 95% confidence intervals will be calculated for participants suffering from AIDS-related lymphomas treated under this regimen. Pharmacokinetics parameters assessment for ibrutinib as well as doxorubicin hydrochloride, etoposide and vincristine sulfate are also secondary outcomes that need to be observed; these variables tabulated via descriptive statistics and nonparametric statistical testing techniques. Finally, researchers aim"

Answered by AI

What is the maximum capacity of participants in this research endeavor?

"In order to complete the study, 54 participants who meet the necessary criteria are needed. Virginia Mason Medical Center in Seattle and Pennsylvania Hospital in Philadelphia have been identified as possible clinical trial sites."

Answered by AI

What are the risks and benefits associated with this pharmacological research?

"This pharmacological investigation has not yet been fully examined for safety and efficacy, thus it scored a 1 on our team's risk scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas
2018. "Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03220022.
~9 spots leftby Jun 2025
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