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Trial record 19 of 145 for:    Venetoclax AND Leukemia

A Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice (REVEAL)

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ClinicalTrials.gov Identifier: NCT03659669
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study will evaluate effectiveness and safety in routine clinical practice in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).

Condition or disease
Chronic Lymphocytic Leukemia (CLL)

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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Observational Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice
Actual Study Start Date : February 10, 2019
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024


Group/Cohort
Patients with Chronic Lymphocytic Leukemia (CLL)
Patients with diagnosed CLL and eligible to venetoclax as per label.



Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]
    ORR to treatment is defined as the proportion of patients with complete response (CR), Complete Response with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR) and partial response (PR), according to physician's assessment.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]
    ORR to treatment is defined as the proportion of patients with complete response (CR), Complete Response with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR) or partial response (PR), according to physician's assessment.

  2. Complete Response (CR) Rate [ Time Frame: Up to approximately 24 months ]
    CR is defined as the proportion of participants with either CR and CRi, according to physician's assessment.

  3. Time to Response (TTR) [ Time Frame: Up to approximately 24 months ]
    TTR is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented the response among complete response, complete response with incomplete bone marrow recovery, nodular partial response, and partial response.

  4. 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 assessment having documented the best response among CR, CRi, nPR, and PR.

  5. Overall Survival (OS) [ Time Frame: Up to approximately 48 months ]
    Overall survival (OS) is defined as the time from the date of first venetoclax intake to the date of death from any cause.

  6. Time To Progression (TTP) [ Time Frame: Up to approximately 48 months ]
    The Time To Progression (TTP) is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression.

  7. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 48 months ]
    PFS is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression or death from any cause.

  8. Time To Next Treatment [ Time Frame: Up to approximately 48 months ]
    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.

  9. Duration of Response (DOR) [ Time Frame: Up to approximately 48 months ]
    DOR is calculated in the sub-population of patients experiencing treatment response (complete response, complete response with incomplete bone marrow recovery, nodular partial response or partial response) from the date when response is first met to the date of first following documented progression.

  10. PFS after Disease Progression Following Venetoclax Treatment [ Time Frame: Up to approximately 48 months ]
    PFS following venetoclax treatment is defined as the time from the date of first next CLL treatment intake to the date of the following documented progression or death from any cause.

  11. Best Response under Next CLL Treatment [ Time Frame: Up to approximately 48 months ]
    The best response under next CLL treatment is calculated in the sub-population of participants having a next CLL treatment after venetoclax discontinuation.

  12. Minimal Residual Disease [ Time Frame: Up to approximately 24 months ]
    The proportion of participants with assessment of the minimal residual disease under venetoclax treatment (assessed by flow cytometry or Polymerase Chain Reaction).

  13. Change in Score of EuroQol 5 Dimensions (EQ‐5D‐5L) [ Time Frame: Up to approximately 24 months ]
    The EQ‐5D‐5L has five dimensions: mobility, self‐care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five‐level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The scores for the 5 dimensions are used to compute a single utility index score ranging from zero (0.0) to 1 (1.0) representing the general health status of the individual. The EQ‐5D‐5L also contains a visual analog scale (VAS) to assess the subject's overall health.



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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
Participants with diagnosed CLL and receiving venetoclax as per label.
Criteria

Inclusion Criteria:

  • Participants with diagnosed Chronic Lymphocytic Leukemia (CLL) and eligible for venetoclax as per label.
  • Participants for whom the physician has decided to initiate CLL treatment with venetoclax.
  • Participants who have been informed verbally and in writing about this study, and who do not object to their data being processed or subjected to data quality control.

Exclusion Criteria:

  • Participants currently participating (or previously participated) in an interventional clinical trial within 30 days prior to venetoclax 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): NCT03659669


Contacts
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Contact: Hilla Banayan +972 (0) 97 90 9655 hilla.banayan@abbvie.com

Locations
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Israel
Soroka Medical Center /ID# 207897 Not yet recruiting
Be'er Sheva, HaDarom, Israel, 84101
Rabin Medical Center /ID# 206961 Recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
HaEmek Medical Center /ID #210900 Not yet recruiting
Afula, Israel, 1834111
Bnai Zion Medical Center /ID# 206963 Recruiting
Haifa, Israel, 3339419
Rambam Medical Center /ID# 210320 Not yet recruiting
Haifa, Israel, 3525408
Shaare Zedek Medical Center /ID# 207896 Recruiting
Jerusalem, Israel, 91031
Hadassah /ID# 207898 Recruiting
Jerusalem, Israel, 91120
Galilee Medical Center /ID# 207899 Recruiting
Nahariya, Israel, 22100
Sheba Medical Center /ID #207900 Not yet recruiting
Ramat Gan, Israel
Kaplan Medical Center /ID# 207902 Recruiting
Rehovot, Israel, 76100
Tel Aviv Medical Center /ID# 206962 Recruiting
Tel Aviv, Israel, 64239
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03659669     History of Changes
Other Study ID Numbers: P19-287
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 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
Cancer
venetoclax
observation
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Venetoclax
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents