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Alkylating agents

Daratumumab + Chemotherapy for Lymphoma

Phase < 1
Recruiting
Led By Ariela Noy, MD
Research Sponsored by AIDS Malignancy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage II-IV disease (Ann Arbor staging criteria) or stage I disease with elevated lactate dehydrogenase (LDH) or bulky tumor (> 7.5 cm).
Participants must have measurable disease (unless marrow-only disease is present), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter) as >= 15 mm (>= 1.5cm) by computed tomography (CT) or positron emission tomography (PET) scan or evaluable by bone marrow.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying how well daratumumab in combination with standard chemotherapy works in treating patients with newly diagnosed stage I-IV plasmablastic lymphoma.

Who is the study for?
This trial is for adults with newly diagnosed stage I-IV plasmablastic lymphoma. Participants can be HIV-positive or negative but must meet specific criteria, including certain blood cell counts and organ function levels. They should not have had previous chemotherapy for lymphoma, except under certain conditions, and cannot have severe lung disease, active hepatitis B or C infections, brain metastases from solid tumors, or a history of allergic reactions to the study drugs.Check my eligibility
What is being tested?
The trial tests daratumumab combined with DA-EPOCH chemotherapy (etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride) in treating plasmablastic lymphoma. Daratumumab targets CD38 protein on cancer cells to help the immune system attack the cancer while chemotherapy aims to stop cancer growth by killing cells or preventing their division.See study design
What are the potential side effects?
Potential side effects include infusion reactions related to daratumumab; nausea; hair loss; mouth sores; low blood cell counts leading to increased infection risk and bleeding problems; heart issues due to doxorubicin; nerve damage from vincristine causing numbness or pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is at an advanced stage or early stage with high LDH/bulky tumor.
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I have a tumor or cancer in my bone marrow that can be measured.
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My lymphoma has been confirmed through specific lab tests.
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My heart pumps well, with an ejection fraction of 45% or higher.
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I can take care of myself but might not be able to do active work.
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I can do most of my daily activities but might need help.
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I am HIV positive but haven't had any major HIV-related infections in the last year.
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My cancer is stage II-IV, or stage I with high LDH or a large tumor.
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My test was FDA-approved.
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My lymphoma has been confirmed through a biopsy.
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I am on HAART treatment for HIV, as prescribed by a doctor.
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My kidney function is within the normal range.

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
Cyclophosphamide
Secondary outcome measures
Complete response (CR) rate
Incidence of adverse events
Overall survival (OS)
+1 more
Other outcome measures
Changes in MYC expression
Changes in levels of Epstein Barr virus (EBV)
Circulating tumor DNA (ctDNA) in plasma
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (daratumumab, DA-EPOCH)Experimental Treatment8 Interventions
Patients receive daratumumab IV on days 1 (± 3 days), 8 (± 2 days), and 15 (± 2 days), of cycles 1-3, and on day 1 of cycles 4-6. Patients also receive etoposide, doxorubicin hydrochloride, and vincristine sulfate IV continuous over 96 hours on days 1-4, prednisone PO on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for up to 6 cycles in 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
Etoposide
2010
Completed Phase 3
~2440
Daratumumab
2014
Completed Phase 3
~1860
Doxorubicin
2012
Completed Phase 3
~7940
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Vincristine Sulfate
2005
Completed Phase 3
~10110
Vincristine
2003
Completed Phase 4
~2910
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

AIDS and Cancer Specimen ResourceOTHER
7 Previous Clinical Trials
1,015 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,476 Total Patients Enrolled
1 Trials studying Plasmablastic Lymphoma
7 Patients Enrolled for Plasmablastic Lymphoma
AIDS Malignancy ConsortiumLead Sponsor
63 Previous Clinical Trials
9,611 Total Patients Enrolled
3 Trials studying Plasmablastic Lymphoma
218 Patients Enrolled for Plasmablastic Lymphoma

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04139304 — Phase < 1
Plasmablastic Lymphoma Research Study Groups: Treatment (daratumumab, DA-EPOCH)
Plasmablastic Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04139304 — Phase < 1
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04139304 — Phase < 1

Frequently Asked Questions

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

How many sites are managing this research endeavor?

"This trial is now recruiting patients from 6 different geographical locations, including Chapel Hill, Baltimore and Columbus. To reduce the need for travel when participating in this study, participants should select a site close to them."

Answered by AI

Is enrollment in this trial still an option for interested participants?

"Affirmative. Clinical trials' online records indicate this research is presently recruiting participants, with the trial's initial posting occurring on 24th May 2021 and its most recent update taking place 12th September 2022. Across 6 medical centres, 15 individuals are needed to complete the study."

Answered by AI

What prior studies have been conducted to investigate the efficacy of Daratumumab?

"Currently, 1566 Daratumumab studies are underway with 347 of those in the Phase 3 stage. While most trials for this medication take place in Bethesda, Maryland, there are 61011 sites offering clinical trails across the country."

Answered by AI

What maladies has Daratumumab been proven useful in treating?

"Daratumumab is a potent therapeutic agent that has been approved to treat prostate cancer, pheochromocytomas and ulcerative colitis."

Answered by AI

Has this treatment protocol been explored before?

"To date, 1566 active trials for Daratumumab have been run in 81 different countries and 3115 cities. Alfacell first began a trial involving 300 participants back in 1997; since then, 2405 studies have been conducted regarding this drug's safety and efficacy. The initial clinical trial achieved its Phase 3 Drug Approval stage of development."

Answered by AI

How many volunteers are involved in this clinical trial?

"The Emmes Company, LLC is sponsoring this clinical trial and needs 15 participants that meet the necessary qualifications. The research will be conducted at UNC-Chapel Hill in North carolina, as well as Johns Hopkins University/Sidney Kimmel Cancer Center in Maryland."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. Memorial Sloan Kettering Cancer Center: < 24 hours
Typically responds via
Phone Call
~5 spots leftby Jul 2025