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

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ClinicalTrials.gov Identifier: NCT03873857
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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
Chronic Lymphocytic Leukemia (CLL) Cancer Drug: Venetoclax

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Study Type : Observational
Estimated Enrollment : 70 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 : February 25, 2019
Estimated Primary Completion Date : March 27, 2022
Estimated Study Completion Date : March 27, 2022


Group/Cohort 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




Primary Outcome Measures :
  1. Objective Response Rate (ORR) 12 Months after Treatment Initiation [ Time Frame: 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 :
  1. Objective Response Rate (ORR) 24 Months after Treatment Initiation [ Time Frame: 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.

  2. Time to First Response to Treatment [ Time Frame: 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).

  3. Time to Best Response to Treatment [ Time Frame: 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).

  4. Duration of Response (DoR) [ Time Frame: 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.

  5. Time To Next Treatment [ Time Frame: 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.

  6. Percentage of Patients with Undetectable Minimal Residual Disease (MRD) [ Time Frame: 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.

  7. Overall Survival (OS) Rate [ Time Frame: 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.

  8. Progression-free Survival (PFS) [ Time Frame: 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

  9. Change from Baseline in RAND Short Form (SF)-36 Questionnaire [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsed or refractory CLL in a real-world clinical practice setting.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873857


Contacts
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Contact: Olesya Magdych +7 495 258 4277 olesya.magdych@abbvie.com

Locations
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Russian Federation
Moscow State budget healthcare institution City Clinical Hospital n.a. Botkin /ID# 212875 Recruiting
Moscow, Moskva, Russian Federation, 125284
Volgograd Regional Clinical Oncology Dispensary /ID# 212366 Recruiting
Volgograd, Volgogradskaya Oblast, Russian Federation, 400138
KGBUZ Regional Clinical Hospital № 1 named. Professor S.I. Sergeev /ID# 212367 Recruiting
Khabarovsk, Russian Federation, 680009
State Budgetary Health Institution "Clinical Medical Sanitary Unit No. 1" /ID# 212364 Recruiting
Perm, Russian Federation, 614077
Russian Research Institute of Hematology and Transfusiology /ID# 212372 Recruiting
Sankt-Peterburg, Russian Federation, 191024
St. Petersburg state medical University. Acad. I.P. Pavlova /ID# 212368 Recruiting
Sankt-Peterburg, Russian Federation, 197022
FGBU "NMIC them. V.A. Almazov "of the Ministry of Health of the Russian Federati /ID# 212365 Recruiting
Sankt-Peterburg, Russian Federation, 197341
Komi Republican Oncologic Dispensary /ID# 212370 Recruiting
Syktyvkar, Russian Federation, 167904
GBUZ City Clinical Hospital № 5 /ID# 212369 Recruiting
Vladimir, Russian Federation, 600031
BUZ IN "Vologda Regional Clinical Hospital" /ID# 212471 Recruiting
Vologda, Russian Federation, 160002
GAU of the Republic of Sakha (Yakutia) "Republican hospital №1-national center o /ID# 212371 Recruiting
Yakutsk, Russian Federation, 677000
Central City Hospital №7 /ID# 212373 Recruiting
Yekaterinburg, Russian Federation, 620137
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03873857     History of Changes
Other Study ID Numbers: P19-569
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Chronic Lymphocytic Leukemia (CLL)
Cancer
Observational Study
Venetoclax
Relapsed Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Additional relevant MeSH terms:
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Venetoclax
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents