FORTE: A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation

Sponsor

AbbVie (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03873857

Collaborator

(none)

Enrollment

Locations

43.1

Anticipated Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study seeks to assess the effectiveness and safety of venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) in a real-world setting across clinical practice in the Russian Federation.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia (CLL) Cancer	Drug: Venetoclax

Study Design

Study Type:

Observational

Actual Enrollment :

71 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Population of Relapse or Refractory Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FORTE)

Actual Study Start Date :

Feb 25, 2019

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Venetoclax Participants in this observational study will receive treatment with venetoclax for up to 24 months for treatment of relapsed or refractory CLL. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.	Drug: Venetoclax tablet;oral Other Names: Venclexta ABT-199

Arm

Intervention/Treatment

Venetoclax

Participants in this observational study will receive treatment with venetoclax for up to 24 months for treatment of relapsed or refractory CLL. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Drug: Venetoclax

tablet;oral

Other Names:

Venclexta

ABT-199

Outcome Measures

Primary Outcome Measures

Objective Response Rate (ORR) 12 Months after Treatment Initiation [Up to approximately 12 months after treatment initiation]
ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment.

Secondary Outcome Measures

Objective Response Rate (ORR) 24 Months after Treatment Initiation [Up to approximately 24 months after treatment initiation]
ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment.
Time to First Response to Treatment [Up to approximately 24 months]
The time to response to treatment is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented a response (CR, CRi, nPR, and PR).
Time to Best Response to Treatment [Up to approximately 24 months]
The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the best response documented (CR, CRi, nPR, and PR).
Duration of Response (DoR) [Up to approximately 24 months]
DoR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the date of disease progression or death from any cause, whichever comes first.
Time To Next Treatment [Up to approximately 24 months]
The time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation.
Percentage of Patients with Undetectable Minimal Residual Disease (MRD) [Up to approximately 24 months]
Patients will be defined as having a clinical remission in the absence of MRD when they have blood or marrow with less than one CLL cell per 10000 leucocytes.
Overall Survival (OS) Rate [Up to approximately 24 months]
OS is defined as number of days from the date of first dose to the date of the observational period end or death for all dosed patients.
Progression-free Survival (PFS) [Up to approximately 24 months]
Progression-free survival is defined as the interval between the first treatment day to the first sign of disease progression or death from any cause
Change from Baseline in RAND Short Form (SF)-36 Questionnaire [Up to approximately 24 months]
Patient quality of life was measured by the RAND-36 health-related quality of life (HRQoL) survey instrument. This questionnaire is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Has a confirmed diagnosis of relapsed or refractory CLL.
Patient for whom the physician has decided to initiate CLL treatment with venetoclax (mono and combo therapy), or up to 4 weeks after venetoclax treatment initiation
Patient voluntarily agrees to participate in this study and signs informed consent form

Exclusion Criteria:

Has contraindications to venetoclax as listed on the approved local label in Russian Federation.
Has Richter syndrome
Participated in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncology Dispensary #2 /ID# 215831	Sochi	Krasnodarskiy Kray	Russian Federation	354057
2	Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 215830	Moscow	Moskovskaya Oblast	Russian Federation	129110
3	Moscow State budget healthcare /ID# 212875	Moscow	Moskva	Russian Federation	125284
4	Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 212368	St. Petersburg	Sankt-Peterburg	Russian Federation	197101
5	Central City Hospital #7 /ID# 212373	Yekaterinburg	Sverdlovskaya Oblast	Russian Federation	620137
6	Regional Children's Clinical Hospital of Volgograd /ID# 212366	Volgograd	Volgogradskaya Oblast	Russian Federation	400138
7	Krai Clinical Hospital /ID# 224952	Barnaul		Russian Federation	656024
8	GBUZ Regional Cancer center /ID# 216871	Irkutsk		Russian Federation	664032
9	Krai Clinical Hospital #1 /ID# 212367	Khabarovsk		Russian Federation	680009
10	Kirov Regional Clinical Hospital /ID# 217579	Kirov		Russian Federation	610027
11	Policlinic #2 /ID# 214778	Oryol		Russian Federation	302040
12	Clinical Medico-Sanitary Unit #1 /ID# 212364	Perm		Russian Federation	614077
13	Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 212372	Sankt-Peterburg		Russian Federation	191024
14	Almazov National Medical Research Centre /ID# 212365	Sankt-Peterburg		Russian Federation	197341
15	Komi Republican Oncology Dispensary /ID# 212370	Syktyvkar		Russian Federation	167904
16	City Clinical Hospital # 5 /ID# 212369	Vladimir		Russian Federation	600031
17	Regional Clinical Hospital of Vologda /ID# 212471	Vologda		Russian Federation	160002
18	Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 212371	Yakutsk		Russian Federation	677008
19	Sverdlovsk Regional Clinical Hospital #1 /ID# 214777	Yekaterinburg		Russian Federation	620102
20	Sakhalin Regional Clinical Hospital /ID# 222503	Yuzhno-Sakhalinsk		Russian Federation	693004