← Back to Search

Alkylating agent

Duvelisib/CC-486 + Chemotherapy for Lymphoma

Phase 2
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying the effect of combining duvelisib or CC-486 with usual chemotherapy drugs in treating patients with peripheral T-cell lymphoma.

Who is the study for?
Adults (18+) with peripheral T-cell lymphoma, not including certain subtypes or those with large cell transformation of mycosis fungoides. Participants must have less than 10% CD30 expression in tumors and no active viral infections like HIV or hepatitis B/C unless managed properly. No other concurrent cancers requiring treatment within the last 3 years, except for some localized cases. Must not have had prior systemic therapy for lymphoma, be pregnant/nursing, and should have adequate organ function.Check my eligibility
What is being tested?
The trial is testing how well duvelisib or CC-486 works alongside usual chemotherapy drugs (cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone) in treating peripheral T-cell lymphoma. Duvelisib targets enzymes needed for cancer growth while CC-486 and other chemotherapies aim to kill or stop cancer cells from growing and spreading.See study design
What are the potential side effects?
Potential side effects include problems related to liver function due to enzyme inhibition by duvelisib; typical chemotherapy side effects such as nausea, hair loss, fatigue; increased risk of infection; blood-related issues like anemia; possible heart complications; allergic reactions to medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I haven't had any treatment for lymphoma, except for corticosteroids.
Select...
I can safely receive all drugs in the chemotherapy plan without severe side effects.
Select...
I have tissue samples from previous procedures that can be submitted.
Select...
I do not have HTLV 1/2.
Select...
My lymphoma is a specific type with low CD30 expression.
Select...
I haven't had serious heart problems in the last 6 months.
Select...
My cancer has not spread to my brain or spinal cord.
Select...
I am 18 years old or older.
Select...
My tumor does not show high levels of CD30.
Select...
My cancer type is not excluded by the trial's criteria.

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
Complete remission (CR) rate
Secondary outcome measures
Correlation of follicular helper T-cell phenotype with response, PFS, EFS and OS
Duration of response
Event-free Survival (EFS)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (CC-486, CHO[E]P)Experimental Treatment6 Interventions
Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Patients also receive CC-486 PO QD on days -6 to 0 of cycle -1 and days 8-21 of cycles 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (duvelisib, CHO[E]P)Experimental Treatment6 Interventions
Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Patients also receive duvelisib PO BID on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Arm C (CHO[E]P)Active Control5 Interventions
Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Oral azacitidine
2012
Completed Phase 1
~20
Prednisone
2014
Completed Phase 4
~2370
Duvelisib
2016
Completed Phase 3
~760
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Vincristine
2003
Completed Phase 4
~2910

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,580 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,468 Total Patients Enrolled
Neha Mehta-Shah, MD, MSCIStudy ChairWashington University School of Medicine

Media Library

Cyclophosphamide (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT04803201 — Phase 2
Peripheral T-Cell Lymphoma Research Study Groups: Arm B (CC-486, CHO[E]P), Arm C (CHO[E]P), Arm A (duvelisib, CHO[E]P)
Peripheral T-Cell Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04803201 — Phase 2
Cyclophosphamide (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04803201 — Phase 2

Frequently Asked Questions

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

What potential adverse effects may stem from Oral azacitidine usage?

"Oral azacitidine has been assessed as a two on the safety scale, due to its being in Phase 2 of development and having only some evidence supporting its security."

Answered by AI

Is there still a chance to become involved in this clinical research?

"According to clinicaltrials.gov, this medical trial is still open for enrolment and recruitment. This experiment was first shared on the 30th of July 2021 with its most recent update occurring on September 25th 2022."

Answered by AI

What maladies is Oral azacitidine typically prescribed to treat?

"Merkel cell cancer is typically managed with oral azacitidine. This medication has also demonstrated efficacy in treating conditions like leukemia, ophthalmia, sympathetic and complete blood count anomalies."

Answered by AI

Is there precedent for Oral azacitidine's efficacy in research?

"To date, there are 1502 active clinical investigations into Oral azacitidine with 322 of them in the third phase. Most trials are located at Bethesda, Maryland but there is a total of 56892 sites conducting research on this medication."

Answered by AI

Is this trial a pioneering effort in medical research?

"Oral azacitidine has been under investigation since 1997, when Alfacell sponsored the first clinical trial. This historic study involving 300 people led to phase 3 drug approval and now over 1500 active studies are being conducted worldwide in 79 different countries."

Answered by AI

What is the cap for participants in this experiment?

"This medical trial necessitates 170 eligible participants, who can be recruited from multiple locations such as Emory University Hospital/Winship Cancer Institute in Atlanta, Georgia and Emory Saint Joseph's Hospital in Rochester, Minnesota."

Answered by AI

Are there multiple locations offering this experiment in the metropolitan area?

"At the present moment, 26 different sites are associated with this study. These clinics can be found in places such as Atlanta, Rochester and Philadelphia but also others which span across America's landscape. It is recommended that enrollees select a nearby centre to minimize travelling needs."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
2021. "Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04803201.
~47 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top