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

MEI Pharma

Status and phase: Terminated; Phase 3

Conditions: Marginal Zone Lymphoma; Follicular Lymphoma (FL); Non Hodgkin Lymphoma

Treatments: Drug: Rituximab; Drug: Bendamustine; Drug: Zandelisib; Drug: CHOP

Study type: Interventional

Funder types: Industry

Identifiers

NCT04745832

2020-004199-16 (EudraCT Number)

ME-401-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Rituximab plus Zandelisib

Experimental group

Description:

Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles

Treatment:

Drug: Zandelisib

Drug: Rituximab

Rituximab plus chemotherapy

Experimental group

Description:

Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles

Treatment:

Drug: CHOP

Drug: Bendamustine

Drug: Rituximab