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Chronic Leukemia

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3. Rituximab (Truxima) - Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia or Rheumatoid Arthritis

Rituximab (Truxima) - Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia or Rheumatoid Arthritis Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity

2019 Health Canada - Drug and Health Product Register

4. Venetoclax (Venclexta) - chronic lymphocytic leukemia (CLL)

Venetoclax (Venclexta) - chronic lymphocytic leukemia (CLL) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September

2018 Health Canada - Drug and Health Product Register

5. Duvelisib (Copiktra) - To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma

Duvelisib (Copiktra) - To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma Drug Approval Package: COPIKTRA (duvelisib) U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: COPIKTRA (duvelisib) Company: Verastem Inc. Application Number: 211155 Approval Date: 09/24/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval

2018 FDA - Drug Approval Package

11. RFA: Bosulif for Chronic Myeloid Leukemia – Details

RFA: Bosulif for Chronic Myeloid Leukemia – Details RFA: Bosulif for Chronic Myeloid Leukemia – Details | CADTH.ca Find the information you need RFA: Bosulif for Chronic Myeloid Leukemia – Details RFA: Bosulif for Chronic Myeloid Leukemia – Details Project Number pCODR RFA 0002 Brand Name Bosulif (RFA) Generic Name Bosutinib Tumour Type Leukemia Indication Chronic Myeloid Leukemia Request for Advice Question RFA Question from the Provincial Advisory Group: Is there evidence of clinical benefit (...) sufficient to extend reimbursement eligibility of bosutinib “for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy” without limiting it further to those “for whom subsequent treatment with imatinib, nilotinib and dasatinib is not clinically appropriate”? Review Status Notification to Implement Issued Manufacturer Pfizer Canada Inc. Sponsor pCODR Provincial

2019 CADTH - Pan Canadian Oncology Drug Review

12. Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details

Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details | CADTH.ca Find the information you need Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details Rituximab for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia – Details Project Number pCODR 10180 Brand Name TBD Generic Name Rituximab Strength Tumour Type Lymphoma & Leukemia Indication Non-Hodgkin’s (...) Lymphoma and Chronic Lymphocytic Leukemia Biosimilar Funding Request Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Review Status File-Closed Not Submitted Clarification The submitter notified pCODR that they will not be filing the submission. Pre Noc Submission Yes NOC Date Manufacturer Sandoz Canada Sponsor Sandoz Canada Submission Date (Target Date) Submission Deemed Complete Submission Type Biosimilar – New Drug Stakeholder Input Deadline (target date based on target submission date

2019 CADTH - Pan Canadian Oncology Drug Review

13. Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details

Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details | CADTH.ca Find the information you need Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details Project Number pCODR 10184 Brand Name Truxima Generic (...) Name Rituximab Strength 10 mg/mL Tumour Type Lymphoma & Leukemia Indication Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar Funding Request Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Review Status File-Closed Not Submitted Pre Noc Submission No NOC Date April 4, 2019 Manufacturer Teva Canada Innovation Sponsor Teva Canada Innovation Submission Date (Target Date) May 22, 2019 Submission Deemed Complete Submission Type Biosimilar – New Drug Stakeholder Input Deadline

2019 CADTH - Pan Canadian Oncology Drug Review

14. Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details

Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details | CADTH.ca Find the information you need Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details Project Number pCODR 10162 Brand Name Venclexta in combo Rituximab Generic Name Venetoclax Tumour Type Leukemia Indication Chronic Lymphocytic Leukemia (CLL) Funding (...) Request In combination with rituximab (V+R) is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy Review Status Notification to Implement Issued Pre Noc Submission No NOC Date September 21, 2018 Manufacturer AbbVie Corporation Sponsor AbbVie Corporation Submission Date October 24, 2018 Submission Deemed Complete November 7, 2018 Submission Type New Indication Prioritization Requested Stakeholder Input Deadline ‡ November 7

2019 CADTH - Pan Canadian Oncology Drug Review

15. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 13 October 2016 EMA/725631/2016 Committee for Medicinal Products for Human Use (CHMP) Assessment report Venclyxto (...) time ASO PCR allele specific oligonucleotide polymerase chain reaction AST aspartate aminotransferase Bcl B cell lymphoma BCRi B Cell receptor inhibitor BMI body mass index BR bendamustine rituximab CD cluster of differentiation CI confidence interval CLL chronic lymphocytic leukaemia CPP Critical process parameter CQA Critical Quality Attribute CR complete remission CRi complete remission with incomplete bone marrow recovery CSR clinical study report CT computed tomography CTLS clinical tumour

2017 European Medicines Agency - EPARs

16. Ibrutinib (IMBRUVICA) - for the treatment of patients with chronic lymphocytic leukemia (CLL)

Ibrutinib (IMBRUVICA) - for the treatment of patients with chronic lymphocytic leukemia (CLL) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs

2017 Health Canada - Drug and Health Product Register

17. Venclexta for Chronic Lymphocytic Leukemia – Details

Venclexta for Chronic Lymphocytic Leukemia – Details Venclexta for Chronic Lymphocytic Leukemia – Details | CADTH.ca Find the information you need Venclexta for Chronic Lymphocytic Leukemia – Details Venclexta for Chronic Lymphocytic Leukemia – Details Project Number pCODR 10105 Brand Name Venclexta Generic Name Venetoclax Strength 10mg, 50 mg & 100mg tablet Tumour Type Leukemia Indication Chronic Lymphocytic Leukemia Funding Request As monotherapy for the treatment of patients with chronic (...) lymphocytic leukemia (CLL) who have received at least one prior therapy and who have failed a B-Cell Receptor Inhibitor (BCRi) Review Status Notification to Implement Issued Pre Noc Submission No NOC Date September 30, 2016 Manufacturer AbbVie Corporation Submitter AbbVie Corporation Submission Date July 10, 2017 Submission Deemed Complete July 17, 2017 Submission Type New Indication Prioritization Requested Requested and Granted Stakeholder Input Deadline ‡ July 24, 2017 Check-point meeting September 7

2018 CADTH - Pan Canadian Oncology Drug Review

18. Treatment-Free Remission After Second-Line Nilotinib Treatment in Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Single-Group, Phase 2, Open-Label Study. (Abstract)

Treatment-Free Remission After Second-Line Nilotinib Treatment in Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Single-Group, Phase 2, Open-Label Study. Treatment-free remission (TFR)-that is, stopping tyrosine kinase inhibitor (TKI) therapy without loss of response-is an emerging treatment goal in chronic myeloid leukemia (CML).To evaluate TFR after discontinuation of second-line nilotinib therapy.Single-group, phase 2, open-label study. (ClinicalTrials.gov (...) : NCT01698905).63 centers in 18 countries.Adults with CML in chronic phase who received TKI therapy for at least 3 years (>4 weeks with imatinib, then ≥2 years with nilotinib) and achieved MR4.5 (BCR-ABL1 ≤0.0032% on the International Scale [BCR-ABL1IS]) while receiving nilotinib entered a 1-year consolidation phase. Those with sustained MR4.5 during consolidation were eligible to enter TFR.Patients received nilotinib during consolidation; those who entered TFR stopped treatment. Patients with loss of major

2018 Annals of Internal Medicine

19. Imatinib dose reduction in major molecular response of chronic myeloid leukemia: results from the German Chronic Myeloid Leukemia-Study IV. Full Text available with Trip Pro

Imatinib dose reduction in major molecular response of chronic myeloid leukemia: results from the German Chronic Myeloid Leukemia-Study IV. Standard first-line therapy of chronic myeloid leukemia is treatment with imatinib. In the randomized German Chronic Myeloid Leukemia-Study IV, more potent BCR-ABL inhibition with 800mg (high-dose) imatinib accelerated achievement of a deep molecular remission. However, whether and when a de-escalation of the dose intensity under high-dose imatinib can (...) be safely performed without increasing the risk of losing deep molecular response is unknown. To gain insights into this clinically relevant question, we analyzed the outcome of imatinib dose reductions from 800mg to 400mg daily in the Chronic Myeloid Leukemia-Study IV. Of the 422 patients that were randomized to the 800mg arm, 68 reduced imatinib to 400mg after they had achieved at least a stable major molecular response. 61 of these 68 patients (90%) maintained major molecular remission on imatinib

2018 Haematologica Controlled trial quality: uncertain

20. Coexistence of chronic myeloid leukemia and diffuse large B-cell lymphoma with antecedent chronic lymphocytic leukemia: a case report and review of the literature Full Text available with Trip Pro

Coexistence of chronic myeloid leukemia and diffuse large B-cell lymphoma with antecedent chronic lymphocytic leukemia: a case report and review of the literature Chronic lymphocytic leukemia and chronic myeloid leukemia are the most common types of adult leukemia. However, it is rare for the same patient to suffer from both. Richter's transformation to diffuse large B-cell lymphoma is frequently observed in chronic lymphocytic leukemia. Purine analog therapy and the presence of trisomy 12 (...) , and CCND1 gene rearrangement have been linked to increased risk of Richter's transformation. The coexistence of chronic myeloid leukemia and diffuse large B-cell lymphoma in the same patient is extremely rare, with only nine reported cases. Here, we describe the first reported case of concurrent chronic myeloid leukemia and diffuse large B-cell lymphoma in a background of chronic lymphocytic leukemia.A 60-year-old Saudi man known to have diabetes, hypertension, and chronic active hepatitis B

2018 Journal of medical case reports

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