Rituximab and Pegylated Interferon α-2b in Patients With Indolent B-cell Lymphoma

Sponsor
Huiqiang Huang
Study ID
NCT04246359
Phase
PHASE2
Status
Unknown

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab Biosimilar — DRUG
    To evaluate the short-term objective efficacy of HLX01 combined with Pegylated Interferon α-2b in patients with advanced idolent B-cell lymphoma.
  • Pegylated Interferon α-2b — DRUG
    To evaluate the short-term objective efficacy of HLX01 combined with Pegylated Interferon α-2b in patients with advanced idolent B-cell lymphoma.

Study Details

A phase 2 open label study to evaluate safety and activity of Rituximab(HLX01) in combination with Pegylated interferon α-2b in patients with newly diagnosed advanced indolent B-cell lymphoma.

Key Dates

First listed
Jan 29, 2020
Start date
Jan 15, 2020
Status verified
Apr 2022
Primary completion
Jun 16, 2022
Completion
Jan 16, 2023

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RP induction and maintenance
    1\. Induction phase: 1. Rituximab: 375mg / m2, ivd, d1; 2. Pegylated interferon α-2b: 135 μg (500,000 U), H, d1, 8 Repeated every 21 days, Maximum 6 cycles 2. Maintenance phase: 1\) Rituximab: 375mg / m2, ivd, d1; 2) Pegylated interferon α-2b: 135 μg (500,000 U), H, d1,30 Repeated every 2 months, Maximum 12 cycles

Primary Outcome Measure

Objective Response Rate (ORR)、Complete Remission Rate (CRR)、Partial Remission Rate (PRR) [ Time Frame: Up to 21 weeks ]

Central Contacts

Related Studies