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

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ClinicalTrials.gov Identifier: NCT04745832
Recruitment Status : Active, not recruiting
First Posted : February 9, 2021
Last Update Posted : January 13, 2023
Sponsor:
Collaborator:
Kyowa Kirin, Inc.
Information provided by (Responsible Party):
MEI Pharma, Inc.

Study Description
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Brief Summary:
This is a Phase 3 study of the PI3Kδ 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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma (FL) Non Hodgkin Lymphoma Marginal Zone Lymphoma Drug: Zandelisib Drug: Rituximab Drug: Bendamustine Drug: CHOP Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Arm 1: Rituximab plus Zandelisib

Arm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study
Actual Study Start Date : August 13, 2021
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : September 2031

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rituximab plus Zandelisib
Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles
 Drug: Zandelisib
Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3
Other Name: ME-401

Drug: Rituximab
Rituximab IV 375 mg/m2 for 6 cycles
Other Names:
  • Rituxan
  • MabThera
Experimental: Rituximab plus chemotherapy
Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles
 Drug: Rituximab
Rituximab IV 375 mg/m2 for 6 cycles
Other Names:
  • Rituxan
  • MabThera

Drug: Bendamustine
Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles
Other Name: Bendeka, Treanda, Belrapzo

Drug: CHOP
Cyclophosphamide, Vindcristine IV, and Prednisone daily orally
Other Name: cyclophosphamide 750 mg/m2, hydroxydoxorubicin IV 50 mg/m2, vincristine IV 1.4 mg/m2 and prednisone 100 mg daily


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 5 years ]
    PFS is defined as the time from randomization date until the date of disease progression, or death from any cause


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 5 years ]
    ORR is defined as the proportion of subjects who have a best overall response of CR or PR according to the Lugano Classification over the entire duration of the study, including the efficacy follow-up period.

  2. Complete Response Rate (CRR) [ Time Frame: 5 years ]
    CRR is defined as the proportion of subjects who have a best overall response of CR during the study (i.e., up to time of analysis of PFS).

  3. Overall Survival [ Time Frame: 10 years ]
    OS is defined as the time (in days) from randomization until death from any cause. For subjects alive at the time of analysis, they will be censored at the last documented alive date.

  4. Number of Treatment Emergent AEs (Zandelisib when combined with Rituximab) [ Time Frame: 5 years ]
    Measured by the number of Treatment Emergent AEs

  5. Number of SAEs (Zandelisib when combined with Rituximab) [ Time Frame: 5 years ]
    Measured by the number of SAEs

  6. Number of Lab Abnormalities (Zandelisib when combined with Rituximab) [ Time Frame: 5 years ]
    Measured by the number of laboratory abnormalities


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. FL Gr 1, Gr 2, or Gr 3a
    2. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745832


Locations
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Sponsors and Collaborators
MEI Pharma, Inc.
Kyowa Kirin, Inc.
More Information
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Responsible Party: MEI Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04745832    
Other Study ID Numbers: ME-401-004
2020-004199-16 ( EudraCT Number )
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Prednisone
Cyclophosphamide
Bendamustine Hydrochloride
Rituximab
Vincristine
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal