Clinical-biological Characteristics and Outcome of Chronic Lymphocytic Leukemia Under Ibrutinib-named Patient Program
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|ClinicalTrials.gov Identifier: NCT02582320|
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : October 6, 2020
|Condition or disease||Intervention/treatment|
|Chronic Lymphocytic Leukemia||Drug: Ibrutinib|
Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults. The disease is characterized by the progressive accumulation of phenotypically mature malignant B lymphocytes, primarily in the peripheral blood, bone marrow, and lymph nodes. Over the last 10-15 years several biological prognostic markers have been identified, starting from the immunoglobulin gene mutational analysis to CD38, ZAP70, CD49d expression, and many others. The very recent discovery of several new genes that carry point mutations in CLL, including NOTCH1, SF3B1 and BIRC3, has added more markers that seem to correlate with resistance to treatment and with transformation into Richter syndrome. A large number of chemoimmunotherapy regimens are currently considered for the treatment of CLL patients.
NPP program The Named Patient Program (NPP) is a program intended to provide early access to ibrutinib in Italy. This program is specifically for patients who have relapsed or refractory chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma.
Rationale In patients with CLL Ibrutinib, given as single agent has shown marked activity and a good safety profile. Data from patients treated with ibrutinib outside a controlled clinical trial within a National Patient Program (NPP) could give additional information about the clinical use, treatment duration, efficacy, and toxicity of ibrutinib given to CLL patients in a real life context.
|Study Type :||Observational|
|Actual Enrollment :||264 participants|
|Official Title:||A Retrospective Study to Evaluate the Clinical-Biologic Characteristics and Outcome of Patients Treated in Italy According to the Ibrutinib-Named Patient Program for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
Patients with Relapsed or refractory CLL or 17p deleted CLL fulfilling the eligibility criteria required by the Named Patient Program (NPP) who received at least 1 dose of Ibrutinib 420 mg daily before November, 30th 2014.
A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start.
- Number of patients who progress [ Time Frame: At 12 months from the start of Ibrutinib ]
- Number of patients who respond to treatment [ Time Frame: At 12 months from enrolment ]CR,PR, L-PR according to the IWCLL 2008 criteria with modification for treatment-related lymphocytosis
- Treatment duration [ Time Frame: At 12 months from enrolment ]
- Time to next treatment in terms of number of days needed [ Time Frame: At 12 months from treatment start ]
- Number of patients surviving [ Time Frame: At 12 months from treatment start ]Overall survival
- Number of patients who reach normal values in the immunoglobulin levels [ Time Frame: At 3, 6 and 12 months from treatment start ]
- Number of patients with toxic events [ Time Frame: At 12 months from treatment start ]
- Number of patients who develop Richter's syndrome and secondary malignancies [ Time Frame: At 12 months from treatment start ]
- Number of patients who require added assistance [ Time Frame: At 12 months from treatment start ]For example: hospitalization, emergency visits, blood product transfusions and use of hematopoietic growth factors, antibiotics.
- Number of patients who fail to treatment. [ Time Frame: At 12 months from treatment start ]
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): NCT02582320
|Study Chair:||Roberto Foà||Policlinico Umberto I, Hematology Department.|