CC-486 for Leukemia, Lymphocytic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Leukemia, Lymphocytic+4 More
CC-486 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective when used with another cancer drug.

Eligible Conditions
  • Leukemia, Lymphocytic
  • Multiple Myeloma
  • Lymphoma, Hodgkins
  • Non-Hodgkin's Lymphoma (NHL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Lymphocytic

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: at 3 and 12 months

Up to 24 months
Duration of Response
Up to 26 months
Maximum Tolerated Dose (MTD)
Overall Survival
Month 12
Overall Response

Trial Safety

Safety Progress

1 of 3

Other trials for Leukemia, Lymphocytic

Side Effects for

CC-486 200 mg
100%Nausea
50%Neutropenia
50%Diarrhoea
50%Fatigue
50%Vomiting
33%Arthralgia
33%Febrile neutropenia
33%Decreased appetite
33%Stomatitis
33%Neutrophil count decreased
17%Inguinal hernia
17%Back pain
17%Syncope
17%Respiratory tract infection
17%Diverticulitis
17%Diabetes insipidus
17%Oral candidiasis
17%Ear infection
17%Cough
17%Blood creatinine increased
17%Hyperammonaemia
17%Bacteraemia
17%Hypothermia
17%Nosocomial infection
17%Pneumonia
17%Oedema peripheral
17%Pyrexia
17%Neck pain
17%Humerus fracture
17%Brain oedema
17%Sinus tachycardia
17%Skin infection
17%Hyperglycaemia
17%Cerebrovascular accident
17%Thrombocytopenia
17%Headache
17%Dizziness
17%Hypocalcaemia
17%Hypomagnesaemia
17%Hypoglycaemia
17%Hypoalbuminaemia
17%Hypokalaemia
17%Toothache
17%Metabolic acidosis
17%Pain of skin
17%Musculoskeletal chest pain
17%Neuropathy peripheral
17%Productive cough
17%Insomnia
17%Anxiety
17%Rhinorrhoea
17%Decubitus ulcer
17%Pruritus generalised
17%Rash maculo-papular
17%Hypotension
17%Anaemia
17%Eye oedema
17%Abdominal distension
17%Septic shock
17%Deafness unilateral
17%Dental caries
17%Constipation
17%Abdominal pain
17%Abdominal pain upper
17%Dyspepsia
17%Blood alkaline phosphatase increased
17%Aspartate aminotransferase increased
17%Upper respiratory tract infection
17%Alanine aminotransferase increased
17%Nasal congestion
17%Menstrual disorder
17%Pleural effusion
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT02269943) in the CC-486 200 mg ARM group. Side effects include: Nausea with 100%, Neutropenia with 50%, Diarrhoea with 50%, Fatigue with 50%, Vomiting with 50%.

Trial Design

1 Treatment Group

Dose Escalation
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: CC-486 · No Placebo Group · Phase 1

Dose EscalationExperimental Group · 2 Interventions: CC-486, Duvelisib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Duvelisib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 3 and 12 months

Who is running the clinical trial?

Secura Bio, Inc.Industry Sponsor
8 Previous Clinical Trials
275 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
489 Previous Clinical Trials
123,340 Total Patients Enrolled
3 Trials studying Leukemia, Lymphocytic
112 Patients Enrolled for Leukemia, Lymphocytic
Hayder Saeed, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
1 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients must have progressed after at least two line of therapy with no available options that would provide clinical benefit per investigator discretion
Patients must have measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
You are 18 years of age or older.\n
You have adequate organ and marrow function as defined in protocol.
The man must take at least 93 days of appropriate contraception after the last dose of study treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.