NCT04342117

Brief Summary

This study will assess whether there are differences in effectiveness and safety outcomes among PI3K-treated patients in a real world registry, compared to patients treated in clinical trials.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 24, 2020

Last Update Submit

March 15, 2021

Conditions

Lymphoma, Small LymphocyticLymphomaLymphoma, Non-HodgkinChronic Lymphocytic LeukemiaFollicular Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Event-Free Survival (EFS)

    Observe the effectiveness of the PI3K-inhibitor administered

    2 years

Secondary Outcomes (4)

  • Measurement of Quality of Life - EQ-5D

    2 years

  • Measurement of Quality of Life - FACT-lym

    2 years

  • Characterize patient characteristics initiating treatment with PI3K-inhibitors

    2 years

  • Measure Time to Next Treatment (TTNT)

    2 years

Study Arms (2)

Duvelisib

Patients who take duvelisib.

Drug: duvelisib

Other PI3K-inhibitors

Patients who take a PI3K-inhibitor other than duvelisib

Drug: PI3K inhibitor

Interventions

duvelisibDRUG

25 mg BID, 15 mg BID

Also known as: Copiktra, VS-0145
Duvelisib
PI3K inhibitorDRUG

FDA approved PI3K inhibitors

Other PI3K-inhibitors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 200 patients with a clinical or pathological diagnosis of CLL/SLL or pathological diagnosis of FL, for whom the Investigator has decided PI3K-inhibitor treatment is the appropriate therapy will be enrolled

You may qualify if:

  • Clinical or pathological diagnosis of CLL/SLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) diagnosis guideline or pathological diagnosis of FL, for whom the Investigator has decided that PI3K-inhibitor treatment is the appropriate therapy
  • Patients previously treated with PI3K-inhibitors are eligible for this study if they:
  • Are restarting treatment with PI3K-inhibitor at enrollment, or
  • Restarted PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment
  • Patients newly treated with PI3K-inhibitors are eligible for this study if they:
  • Are starting treatment with PI3K-inhibitors at enrollment, or
  • Started on PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment
  • ≥18 years of age at time consent is provided to participate in this study
  • For patients treated with PI3K-inhibitors prior to enrollment in the study, availability of documentation of previous PI3K-inhibitor treatment, including the start date of previous or current PI3K-inhibitor treatment in patient charts or medical records
  • Patient is willing and able to provide a signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF)

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CARTI Cancer Center

Little Rock, Arkansas, 72205, United States

Location

Joliet Oncology-Hematology Associates, LTD

Joliet, Illinois, 60435, United States

Location

Goshen General Hospital

Goshen, Indiana, 46526, United States

Location

McFarland Clinic,PC

Ames, Iowa, 50010, United States

Location

St. Agnes Hospital

Baltimore, Maryland, 21229, United States

Location

Regional Cancer Care Associates LLC

Bethesda, Maryland, 20817, United States

Location

Hattiesburg Clinic, PA

Hattiesburg, Mississippi, 39401, United States

Location

Capital Region Medical Center

Jefferson City, Missouri, 65101, United States

Location

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

Location

NY Cancer and Blood Specialists

Port Jefferson Station, New York, 11776, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphomaLymphoma, Non-HodgkinLymphoma, Follicular

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

April 10, 2020

Study Start

April 23, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

US(11)