ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04578613
• Collaborator: (none)
• Enrollment: 218
• Locations: 56
• Arms: 2
• Anticipated Duration (Months): 53.7
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of ICP-022 versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma	Drug: ICP-022; Drug: Chlorambucil; Drug: Rituximab	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 218 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled, Open, Multicenter Phase 3 Study to Evaluate ICP-022 Versus Chlorambucil Combined With Rituximab for Primary Treatment of Chronic Lymphocytic Leukemia(CLL)/ Small Lymphocytic Lymphoma(SLL)
• Actual Study Start Date: Jan 8, 2021
• Anticipated Primary Completion Date: Dec 30, 2024
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICP-022 ICP-022 will be orally administered until disease progression or unacceptable toxicity.	Drug: ICP-022; ICP-022 at a dose of 150mg, QD
Active Comparator: Chlorambucil combined with Rituximab Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.	Drug: Chlorambucil; 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6; Drug: Rituximab; 375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [Up to 5 years]

   Progress-free survival (PFS) was evaluated by the independent review board (IRC) against the IWCLL2018 criteria (Hallek et al., 2018) and the revised lymphoma mitigation assessment criteria (Cheson et al., 2014).

Secondary Outcome Measures

1. Objective Response Rate (ORR) [Up to 5 years]

2. Duration Of Response (DOR) [Up to 5 years]

3. Overall Survival (OS) [Up to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

1. Male or female, age ≥65 years old or age >18 years old or <65 years old, age >18 years old or <65 years old shall meet any of the following criteria simultaneously: A.Disease accumulation score (CIRS) > 6;B. Creatinine clearance at 30-69 mL/ min (Cockcroft-Gault assessment)

2. Enhanced computed tomography/magnetic resonance imaging (CT/MRI) detection had measurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm and had a measurable vertical dimension

3. ECOG physical strength score is 0-2.

4. Expected survival time >6 months.

5. Voluntary written informed consent prior to screening.

Key Exclusion Criteria:

1. Patients with stroke or intracranial hemorrhage in the first 6 months were randomly assigned.

2. Hypersensitivity to ICP-022, nitrogen mustard benzoate, rituximab or any other component of the applicable study drug.

3. Any mental or cognitive impairment that may limit their understanding of the informed consent, their implementation and their compliance with the study.

4. Pregnant and lactating women, or subjects of childbearing age who do not want to use contraception within 180 days from the end of the study period to the end of the study period.

5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui	China
2	Anhui Provincial Cancer Hospital	Hefei	Anhui	China
3	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China
4	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing	China
5	The First Affiliated Hospital of Congqing Medical University	Chongqing	Chongqing	China	400000
6	The Second Affiliated Hospital of Army Medical University	Chongqing	Chongqing	China
7	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China
8	Lanzhou University Second Hospital	Lanzhou	Gansu	China
9	Dongguan People's Hospital	Dongguan	Guangdong	China	523058
10	Cancer Prevention and Treatment Center, Sun Yat-sen University	Guangzhou	Guangdong	China
11	Guangzhou First People's Hospital	Guangzhou	Guangdong	China
12	Shenzhen People's Hospital	Shenzhen	Guangdong	China
13	Affiliated Hospital of Guilin Medical College	Guilin	Guangxi Zhuang Autonomous Region	China	541000
14	Affiliated Hospital of Hebei University	Baoding	Hebei	China
15	Hebei Medical University Second Hospital	Shijiazhuang	Hebei	China	h
16	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
17	Affiliated Tumor Hospital of Harbin Medical University	Ha'erbin	Heilongjiang	China
18	The first Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan	China
19	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
20	Henan Cancer Hospital	Zhengzhou	Henan	China
21	Henan Province Hospital	Zhengzhou	Henan	China
22	Zhongnan Hospital of WuHan University	Wuhan	Hubei	China	430071
23	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China
24	Yichang Central People's Hospital	Yichang	Hubei	China
25	Yichang First People's Hospital	Yichang	Hubei	China
26	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China	410000
27	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China
28	Zhuzhou Central Hospital	Zhuzhou	Hunan	China	412007
29	Jiangsu Province Hospital	Nanjing	Jiangsu	China
30	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China
31	Wuxi People's Hospital	Wuxi	Jiangsu	China
32	Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China
33	Subei People's Hospital	Yangzhou	Jiangsu	China
34	The First Affiliated Hospital of Gannan Medical College	Ganzhou	Jiangxi	China	341004
35	Jiangxi Cancer Hospital	Nanchang	Jiangxi	China
36	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China
37	Shengjing Hospital of China Medical University	Dalian	Liaoning	China
38	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China
39	Affiliated Hospital of Binzhou Medical College	Binzhou	Shandong	China
40	Shandong Cancer Hospita	Jinan	Shandong	China	250117
41	Shandong Provincial Hospital	Jinan	Shandong	China
42	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200025
43	The Second Affiliated Hospital of Xi´an Jiaotong University	Xi'an	Shanxi	China	710000
44	Sichuan Provincial People's Hospital	Chengdu	Sichuan	China
45	West China Hospital of Sichuan University	Chengdu	Sichuan	China
46	Yibin Second People's Hospital	Yibin	Sichuan	China
47	General Hospital of Tianjin Medical University	Tianjin	Tianjin	China
48	Hospital of Hematology, Chinese Academy of Medical Sciences	Tianjin	Tianjin	China
49	Tianjin Cancer Hospital	Tianjin	Tianjin	China
50	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang Uygur Autonomous Region	China	830011
51	The first Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China
52	Dongyang People's Hospital	Dongyang	Zhejiang	China	322199
53	Shaoyifu Hospital Affiliated to Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310026
54	The First Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang	China
55	Jinhua Central Hospital	Jinhua	Zhejiang	China	321000
56	Ningbo First Hospital	Ningbo	Zhejiang	China

Sponsors and Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04578613
• Other Study ID Numbers: ICP-CL-00111
• First Posted: Oct 8, 2020
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Rituximab; Chlorambucil

Study Results

No Results Posted as of Mar 28, 2022