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Epigenetic Modifier

CC-486 Administration for Peripheral T-Cell Lymphoma

Phase 2
Waitlist Available
Led By Jia Ruan, MD, Ph.D
Research Sponsored by Weill Medical College of Cornell University
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 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment in people who have not received any prior systemic therapy. The primary efficacy analysis uses a two-stage minimax design.

Eligible Conditions
  • Peripheral T-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Complete Response Rate
Secondary outcome measures
Kaplan-Meier Overall Survival
Kaplan-Meier Progression-Free Survival

Side effects data

From 2022 Phase 2 trial • 21 Patients • NCT03542266
90%
Constipation
71%
Nausea
71%
Neutrophil count decreased
67%
Fatigue
62%
Lymphocyte count decreased
57%
White blood cell decreased
52%
Diarrhea
52%
Platelet count decreased
48%
Vomiting
48%
Anemia
33%
Abdominal Pain
29%
Edema limbs
29%
Anorexia
29%
Dizziness
24%
Cough
24%
Alopecia
24%
Dry Mouth
24%
Headache
24%
Neuropathy
24%
Nasal congestion
19%
Non-cardiac chest pain
19%
Anxiety
19%
Pruritus
19%
Hypertension
14%
Alanine aminotransferase increased
14%
Sinus tachycardia
14%
Flatulence
14%
Dysgeusia
14%
Rash maculo-papular
14%
Chest pain - cardiac
14%
Fever
14%
Orthostatic hypotension
14%
Hypoalbuminemia
14%
Bone pain
14%
Hyponatremia
14%
Arthralgia
14%
Upper respiratory infection
10%
Gastroesophageal reflux disease
10%
Neutopenic Fever
10%
Rhinovirus
10%
Alkaline phosphatase increased
10%
Transaminitis
10%
Aspartate aminotransferase increased
10%
Oral Candidiasis
10%
Hypercalcemia
10%
Erythema
10%
Superficial thrombophlebitis
10%
Night sweats
10%
Insomnia
10%
Hypotension
10%
Weight loss
10%
Mucositis Oral
10%
Generalized weakness
10%
Stomach Pain
10%
Hypocalcemia
10%
Rhinorrhea
10%
Skin infection
10%
Myalgia
10%
Syncope
10%
Sore throat
5%
Stroke
5%
Lung Infection, COVID-19
5%
Generalized muscle weakness
5%
Cellulitis
5%
Blood Bilirubin Increase
5%
Influenza A
100%
80%
60%
40%
20%
0%
Study treatment Arm
CC486 +CHOP

Trial Design

1Treatment groups
Experimental Treatment
Group I: CC486 +CHOPExperimental Treatment2 Interventions
CC486 +CHOP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-486 Administration
2018
Completed Phase 2
~30
CHOP Administration
2018
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,215 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,288 Total Patients Enrolled
Jia Ruan, MD, Ph.DPrincipal InvestigatorWeill Medical College of Cornell University

Frequently Asked Questions

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

Is this investigation open to individuals younger than 85 years old?

"This trial is only open to patients between 18-80 years old, which leaves out both children and older adults who might benefit from this treatment. There are 322 trials for patients under the age of 18 and 1783 for people over 65."

Answered by AI

How many individuals have signed up to participate in this research project?

"As of April 29th, 2022, this study is not recruiting patients. It was first posted on June 1st, 2018 and has since been updated multiple times. There are other clinical trials looking for participants that might be a match for you; 1773 studies involving lymphoma treatment and 179 studies concerning CC-486 Administration are currently open."

Answered by AI

How can I sign up for the clinical trial?

"The eligibility requirements for this study are that patients must have t-cell lymphoma, be between 18 and 80 years old, and there are looking to recruit around 21 candidates in total."

Answered by AI

Is this the first time CC-486 is being used in a clinical setting?

"As of now, there are 179 ongoing studies researching CC-486 Administration. 33 of those active trials are in Phase 3 testing. The majority of trials for CC-486 Administration are based in Saint Louis, Missouri, but there are 5711 locations running trials for this treatment worldwide."

Answered by AI

What is the main use of CC-486 Administration?

"CC-486 Administration is most typically used to treat cancer, but it can also help patients with 20-30% blasts, neutropenia and/or thrombocytopenia, anemia."

Answered by AI

Are there any dangers that patients should be made aware of before taking CC-486?

"While Phase 2 trials don't have supporting data for efficacy, CC-486 Administration received a safety score of 2 from our team at Power."

Answered by AI

Are volunteers still being accepted for this research?

"This trial is not actively recruiting participants at this time. The study was first posted on 6/1/2018 and was last edited on 4/29/2022; however, there are other active trials for similar conditions that may be of interest. There are currently 1773 clinical trials actively enrolling participants with lymphoma, t-cell, peripheral and 179 studies for CC-486 Administration actively admitting patients"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
2018. "CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03542266.
~3 spots leftby Apr 2025
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