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Anti-metabolites

CC-486 (5-azacitidine) for Nasal Lymphoma

Phase 1
Waitlist Available
Led By Milos Miljkovic, M.D.
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually
Awards & highlights

Study Summary

This trial is testing a combination of 4 drugs to treat T-cell lymphomas, which are rare cancers. The drugs will be given to adults who have newly diagnosed or recurring TCL, and researchers will track the participants' progress.

Eligible Conditions
  • Nasal Lymphoma
  • Hepatosplenic T-cell Lymphoma
  • Adult T-Cell Leukemia/Lymphoma
  • Epithelial T-cell Lymphoma
  • T-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually 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)
Safety and tolerability
Secondary outcome measures
Complete Response Rate
Duration of response (DOR)
Event Free Survival (EFS)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2 - Experimental Treatment: Dose ExpansionExperimental Treatment4 Interventions
Duvelisib (PO BID) at RP2D on days -14 to 14 of C1 and days 1-14 of all other 21-day cycle (max 8 cycles) with CC-486 (5-azacitidine) at 300mg/day (PO) on days 1-10, romidepsin at 12mg/m2 (IV) on days 1 and 8 of each cycle, and doxorubicin at 25 mg/m2 on day 1 of Cycles 3-8 (Cycles 3-6 for patients with prior anthracycline-based therapy
Group II: 1- Experimental Treatment: Dose EscalationExperimental Treatment4 Interventions
Duvelisib (PO BID) at escalating doses of 25, 50 and 75 mg/BID on days -14 to 14 of C1 and days 1-14 of all other cycles of each 21- day cycle (max 8 cycles) with CC-486 (5-azacitidine) (PO) at 300mg/day on days 1-10, romidepsin at 12mg/m2 (IV) on Days 1 and 8 of each cycle and doxorubicin (IV) at 25 mg/ m2 on Day 1 of cycles 3-8 (Cycles 3-6 for patients with prior anthracycline-based therapy), to determine RP2D of duvelisib and doxorubicin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Duvelisib
2016
Completed Phase 3
~760
Romidepsin
2011
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,648 Previous Clinical Trials
40,931,744 Total Patients Enrolled
Milos Miljkovic, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
948 Total Patients Enrolled
Kevin C Conlon, M.D.Principal InvestigatorNational Cancer Institute (NCI)
10 Previous Clinical Trials
1,068 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma
2022. "Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04639843.
~0 spots leftby Apr 2025
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