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Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

NCT04639843 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-11-04

No results posted yet for this study

Summary

Background:

T-cell lymphomas (TCLs) are rare cancers. Many types of TCLs do not develop in the lymph nodes but in places like the skin, spleen, and bone marrow. Researchers want to see if a mix of 4 drugs can help people with TCL.

Objective:

To test if the combination of romidepsin, CC-486 (5-azacitidine), duvelisib, and doxorubicin can be used safely in people with TCL.

Eligibility:

Adults 18 and older with TCL that is newly diagnosed or that returned after or did not respond to standard treatments.

Design:

Participants will be screened on a separate protocol. They may have a tumor biopsy.

Participants will have medical histories, medicine reviews, and physical exams. Their ability to do daily activities will be assessed. They will have blood and urine tests.

Participants will take duvelisib and CC-486 (5-azacitidine) by mouth. They will get romidepsin and doxorubicin by intravenous infusion. They will take the drugs for up to eight 21-day cycles. They will keep a medicine diary.

Participants will have a bone marrow aspiration and/or biopsy. Bone marrow will be taken through a needle inserted in the hip.

Participants will have tumor imaging scans. Some may have a brain MRI and lumbar puncture. Some may have skin assessments.

Participants will give blood, saliva, and tumor samples for research.

Participants will have a safety visit 30 days after treatment ends. Then they will have follow-up visits every 60 days for 6 months, then every 90 days for 2 years, and then every 6 months for 2 years. Then they will have yearly visits until their disease gets worse or they start a new treatment....

Conditions

  • Adult T-cell Leukemia/Lymphoma
  • Extranodal NK-/T-cell Lymphoma, Nasal Type
  • Enteropathy-Associated T-Cell Lymphoma
  • Monomorphic Epiteliotrophic Intestinal T-cell Lymphoma
  • Hepatosplenic T-cell Lymphoma

Interventions

DRUG

CC-486 (5-azacitidine)

CC-486 (5-azacitidine) with a dose of 300mg oral intake daily will be given on day 1 to day 10 for 8 cycles.

DRUG

Duvelisib

Duvelisib by oral intake at escalating doses of 25, 50 and 75 mg/BID on days -14 to 14 of the 1st cycle then days 1-14 of Cycles 2-8 of each 21- day cycle (max 8 cycles).

DRUG

Romidepsin

Romidepsin (12mg/m2) will be administered on days 1 and 8 of each cycle through a peripheral or central intravenous catheter for 8 cycles.

DRUG

Doxorubicin

Doxorubicin at 25 mg/ m2 by IV infusion on Day 1 of cycles 3-8.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kevin C Conlon, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2022-11-03
Completion
2022-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639843 on ClinicalTrials.gov