An early study to investigate a new medicine for Subjects with Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

Phase 1

• Conditions: Subjects with R/R NHL, which includes diffuse large B-cell lymphoma (DLBCL) (not otherwise specified [NOS] or transformed), FL (follicular lymphoma), mantle cell lymphoma (MCL), primary central nervous system lymphoma (PCNSL) or relapsed or refractory marginal zone lymphoma (MZL) who have failed at least 2 lines of therapy (or who have received at least one prior line of standard therapy and are not eligible for any other therapy).; MedDRA version: 24.0Level: 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 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10036685Term: Primary central nervous system 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); MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003235-29-DK
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-22
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

1. Subject is =18 years of age at the time of signing the informed consent form (ICF).
2. Subject has a history of NHL (including DLBCL, FL, MZL, MCL and PCNSL) with relapsed or refractory disease
3. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
4. Subjects must have the following laboratory values:
a. Absolute neutrophil count (ANC) = 1.5 x 10^9/L or = 1 x 10^9/L in
case of documented bone marrow involvement, without growth factor support for 7 days (14 days if pegfilgastrim)
b. Hemoglobin (Hgb) = 8 g/dL
c. Platelets (plt) = 75 x 10^9/L or = 50 x 10^9/L in case of documented
bone marrow involvement, without transfusion for 7 days
d. Serum bilirubin = 1.5 x ULN (upper limit of normal).
e. AST/SGOT and ALT/SGPT = 2.5X ULN
f. Estimated serum creatinine clearance of > 30 mL/min using the Cockcroft-Gault equation or directly determined from the 24-hour urine
collection method or using the modification of diet in renal disease
(MDRD) formula. For Cohort G and H, estimated serum creatinine
clearance of = 45 mL/min using the Cockcroft-Gault equation or directly
determined from the 24-hour urine collection method or using the
modification of diet in renal disease (MDRD) formula.
5. Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP)
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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

1. Subject has life expectancy = 2 months.
2. Subjects who have aggressive lymphoma relapse requiring immediate cytoreductive therapy to avoid potential life-threatening consequences (eg, due to tumor location).
3. Subject has received prior systemic anti-cancer treatment (approved or investigational) = 5 half-lives or 4 weeks prior to starting investigational product(s), whichever is shorter.
4. Subject has symptomatic CNS involvement of disease (does not apply to PCNSL subjects in Part B).
5. Subject is on chronic systemic immunosuppressive therapy or corticosteroids (eg, prednisone or equivalent not to exceed 10 mg per day within the last 14 days) or subjects with clinically significant graft versus- host disease (GVHD).
6. Subject had prior autologous SCT = 3 months prior to starting investigational product(s) and any treatment-related toxicity is unresolved (grade > 1).
7. Subject had prior allogeneic SCT with either standard or reduced intensity conditioning = 6 months prior to starting investigational product(s) and any treatment-related toxicity is unresolved (grade > 1).

Study & Design

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