Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

  • STATUS
    Recruiting
  • End date
    Sep 21, 2031
  • participants needed
    534
  • sponsor
    MEI Pharma, Inc.
Updated on 22 September 2021
cyclophosphamide
rituximab
prednisone
measurable disease
bendamustine
chop regimen

Summary

This is a Phase 3 study of the PI3K inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

Description

This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP).

Subjects must have relapsed after at least one previous line of systemic immunochemotherapy. Previous treatments must have included an anti-CD20 monoclonal antibody (mAb) with chemotherapy such as Bendamustine (B), CHOP, CVP, FND, or similar regimens, or an anti-CD20 mAb with Lenalidomide (L).

Approximately 534 randomized subjects will be enrolled in this study.

Details
Condition Follicular Lymphoma, Lymphoma, MALT Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma, non-hodgkin's lymphoma (nhl)
Treatment Rituximab, CHOP, Bendamustine, Zandelisib
Clinical Study IdentifierNCT04745832
SponsorMEI Pharma, Inc.
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects 18 years of age, 19 years in Korea, or 20 years for subjects in Japan and Taiwan
Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to
FL Gr 1, Gr 2, or Gr 3a
MZL (splenic, nodal, or extra-nodal)
Subjects with relapsed or refractory disease who received 1 prior lines of therapy
Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm
Adequate hematologic parameters at screening unless abnormal values are due to disease
Adequate renal and hepatic function
Adequate cardiac function based on ECG and LVEF assessments

Exclusion Criteria

Histologically confirmed diagnosis of FL Gr 3b or transformed disease
Prior therapy with PI3K inhibitors
Ongoing or history of drug-induced pneumonitis
Known lymphomatous involvement of the central nervous system
Tested positive for or active viral infection with hepatitis B or C virus
Tested positive or active infection with human immunodeficiency virus
Tested positive, or active infection with human T-cell leukemia virus type 1
Any uncontrolled clinically significant illness
History of clinically significant cardiovascular abnormalities such as congestive heart failure
History of clinically significant gastrointestinal (GI) conditions
Females who are pregnant
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note