A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation (FORTE)
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| ClinicalTrials.gov Identifier: NCT03873857 |
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Recruitment Status :
Active, not recruiting
First Posted : March 14, 2019
Last Update Posted : May 14, 2021
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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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 |
| 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 : | February 25, 2019 |
| Estimated Primary Completion Date : | September 30, 2022 |
| Estimated Study Completion Date : | September 30, 2022 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Venetoclax
| Group/Cohort | Intervention/treatment |
|---|---|
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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:
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Primary Outcome Measures :
- 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 :
- 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.
- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
- 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
- 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
Locations
Show 20 study locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | ABBVIE INC. | AbbVie |
Additional Information:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03873857 |
| Other Study ID Numbers: |
P19-569 |
| First Posted: | March 14, 2019 Key Record Dates |
| Last Update Posted: | May 14, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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:
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Chronic Lymphocytic Leukemia (CLL) Cancer Observational Study |
Venetoclax Relapsed Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia |
Additional relevant MeSH terms:
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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 Venetoclax Antineoplastic Agents |