A study of Acalabrutinib alone, or in combination with Rituximab and Lenalidomide for subjects with B-cell Non Hodgkin Lymphoma

Phase 1

• Conditions: B-cell Non-Hodgkin Lymphoma; MedDRA version: 21.1Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000111-84-IT
• Lead Sponsor: ACERTA PHARMA BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Part 1
1. Men and women = 18 years of age.
2. Relapsed/Refractory Cohort
3. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
4. Eastern Cooperative Oncology Group (ECOG) performance status of = 2.
5. Agreement to use highly effective forms of contraception
6. Men must agree to refrain from sperm donation during the study and for 12 months after the last dose of rituximab.

Part 2
1. Men and women = 18 years of age.
2. Histologically confirmed MZL including splenic, nodal, and extranodal sub-types
3. Previous therapy
4. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
5. ECOG performance status of = 2.
6. Women must agree to use highly effective methods of contraception during the study and for 2 days after the last dose of acalabrutinib or 12 months after the last dose of rituximab, whichever is longer, if sexually active and able to bear or beget children. Highly effective methods of contraception are defined in Section 3.6.6.

Part 3 and Part 4
1. Men and women = 18 years of age
2. For subjects with FL: Pathologically confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to = 1 prior therapy for FL and which requires treatment per National Cancer Institute or ESMO clinical practice guidelines.
3. For subjects with non-GCB DLBCL: Pathologically confirmed de novo non-GCB DLBCL based on local IHC using Hans algorithm (Hans 2004) or else subjects must have available archival tissue for central pathology review to be eligible
4. Subjects must have previously received at least 1 frontline standard chemoimmunotherapy regimen.
5. Subjects with suspected residual disease after the treatment regimen directly preceding study enrollment must have biopsy-demonstrated residual FL or DLBCL.

Please, refer to the protocol for the rest of the inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Part 1:
1. Prior malignancy (other than indolent B-cell NHL),
2. Known central nervous system (CNS) lymphoma or leptomeningeal disease.
3. A life-threatening illness, medical condition, or organ system dysfunction,
4. Known history of a bleeding diathesis ,
5. Significant cardiovascular disease

Part 2
1. Prior malignancy,
2. Known medically apparent CNS lymphoma or leptomeningeal disease.
3. Known evidence of transformation to another aggressive lymphoma.
4. A life-threatening illness, medical condition, or organ system dysfunction
5. Known history of a bleeding diathesis (eg, hemophilia, von Willebrand disease).

Part 3 and Part 4:
1. Prior malignancy ,
2. Subjects for whom the goal of therapy is tumor debulking before stem cell transplant.
3. Known history or presence of CNS lymphoma or leptomeningeal disease.
4. Transformed DLBCL or DLBCL with coexistent histologies

Please, refer to the protocol for the rest of the exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified