A Non-Interventional, Observational Phase IV Study to Evaluate Safety of Rituximab (Mabthera®) in Combination With Chemotherapy in Patients Treated With CD20+ Β Chronic Lymphocytic Leukemia

This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.

Start Date01 Apr 2012

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

NCT01138579 / WithdrawnPhase 1/2IIT

Phase I/II Dose-escalation Study of the Investigational Trifunctional Bispecific Anti-CD20 x Anti-CD3 Antibody FBTA05 in Combination With Donor Lymphocyte Infusion (DLI) in Patients With CD20 Positive Chronic Lymphocytic Leukemia (CLL), Low and High Grade Non-Hodgkin´s Lymphoma (NHL) After Allogeneic Stem Cell Transplantation

This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade non-Hodgkin´s lymphoma after allogeneic transplantation

Start Date01 Aug 2010

Sponsor / Collaborator

Technische Universität München

EUCTR2009-014641-88-DE / Not yet recruitingNot ApplicableIIT

Phase I/II dose-escalation study of the investigational trifunctional bispecific anti-CD20 x anti-CD3 antibody FBTA05 in combination with donor lymphocyte infusion (DLI) in patients with CD20 positive chronic lymphocytic leukemia (CLL), low and high grade non-Hodgkin´s lymphoma (NHL) after allogeneic stem cell transplantion. - STP-LYM-01-V01

Start Date14 Jan 2010

Sponsor / Collaborator-

100 Clinical Results associated with CD20 Positive B-Cell Chronic Lymphocytic Leukemia

100 Translational Medicine associated with CD20 Positive B-Cell Chronic Lymphocytic Leukemia

0 Patents (Medical) associated with CD20 Positive B-Cell Chronic Lymphocytic Leukemia

Literatures (Medical) associated with CD20 Positive B-Cell Chronic Lymphocytic Leukemia

03 Mar 2021·Japanese Journal of Clinical OncologyQ4 · MEDICINE

A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia

Q4 · MEDICINE

Article

Author: Tobinai, Kensei ; Takizawa, Jun ; Izutsu, Koji ; Suzumiya, Junji ; Kinoshita, Tomohiro ; Yamamoto, Go ; Ohashi, Yasuo ; Fukuhara, Suguru

AbstractObjectiveFludarabine, cyclophosphamide and rituximab (FCR) is the standard regimen for fit patients with untreated CD20-positive chronic lymphocytic leukemia (CLL). However, this combination is unavailable in Japan because rituximab is not approved for CLL. We investigated the efficacy and safety of FCR in this single-arm, multicenter study designed as a bridging study to the CLL8 study by the German CLL Study Group.MethodsThe study enrolled previously untreated patients with CLL of Binet stage B or C with active disease. Patients with a Cumulative Illness Rating Scale score of ≤6 and creatinine clearance of ≥70 ml/min were eligible. Patients received 6 cycles of FCR every 28 days and were followed for up to 1 year.ResultsSeven patients were enrolled. The best overall response rate according to the 1996 NCI-WG Guidelines, the primary endpoint of the study, was 71.4% (95% confidence interval, 29.0–96.3%), with one patient achieving complete response. No deaths or progression occurred during follow-up. The main adverse event was hematotoxicity. CD4-positive T-cell count decreased in all patients; most patients showed no reduction in serum immunoglobulin G.ConclusionAlthough the number of patients was limited, FCR appears to be effective with manageable toxicity for treatment-naïve fit Japanese patients with CD20-positive CLL.Clinical trial numberJapicCTI-132285.

01 Oct 2016·Leukemia ResearchQ4 · MEDICINE

New monoclonal antibodies for the treatment of acute lymphoblastic leukemia

Q4 · MEDICINE

Review

Author: Litzow, Mark R ; Farhadfar, Nosha

Monoclonal antibodies represent a major advance in treatment of acute lymphoblastic leukemia (ALL). Targeted delivery of these agents based on leukemic cell-surface receptor recognition, improves efficacy and minimizes off-target toxicity. The antigens CD19, CD20, CD22 and CD52, are the most common antigens to which monoclonal antibodies in B-cell ALL have been directed. Rituximab, an anti-CD20 antibody, in combination with conventional chemotherapy has been shown to improve survival in newly diagnosed CD20 positive B-cell ALL. Blinatumomab, a bispecific T-cell engager, as monotherapy in relapsed and refractory B-cell ALL resulted in prolonged relapse free survival. Inotuzumab ozogamicin, an anti-CD22 antibody, alone and in combination with chemotherapy has been promising in relapsed and refractory B-cell ALL. The effectiveness and safety of several newer monoclonal antibodies including ofatumumab, obinutuzumab, epratuzumab, denintuzumab mafodotin and moxetumomab pasudotox as single agents or in combination with a chemotherapeutic back bone are currently under investigation.

01 Feb 2015·American Journal of HematologyQ1 · MEDICINE

Phase II study of methotrexate, vincristine, pegylated‐asparaginase, and dexamethasone (MOpAD) in patients with relapsed/refractory acute lymphoblastic leukemia

Q1 · MEDICINE

Article

Author: Ravandi, Farhad ; Borthakur, Gautam ; Estrov, Zeev ; Cortes, Jorge ; Brandt, Mark ; Jabbour, Elias ; Pierce, Sherry ; Pemmaraju, Naveen ; Thomas, Deborah A. ; O'Brien, Susan ; Jain, Preetesh ; Kantarjian, Hagop M. ; Daver, Naval ; Garcia‐Manero, Guillermo ; Wang, Xuemei ; Kadia, Tapan M.

Newer approaches are needed for the treatment of relapsed and refractory acute lymphoblastic leukemia (ALL). Asparaginase‐based regimens are active in the treatment of pediatric ALL and may be important in salvage therapy for adult patients. We conducted a pilot trial combining methotrexate, vincristine, PEGylated‐asparaginase, and dexamethasone (MOpAD) in adults with relapsed or refractory ALL. We added tyrosine kinase inhibitors in patients with Philadelphia chromosome positive (Ph+) ALL and rituximab in patients with CD20 positive B‐cell ALL. Among 37 patients treated (median age 42 years; median 2 prior therapies), the complete remission (CR) rate was 28% and an overall response rate (ORR) was 39%. The median CR duration was 4.3 months. Patients with Ph+ ALL had CR and ORR of 50% and 67%, respectively and the CR and ORR in patients with T‐cell leukemia were 45% and 56%, respectively. The median survival in patients with CR/CRp was 10.4 versus 3.4 months in nonresponders (P = 0.02). The most common grade 3 or 4 nonhematologic toxicities were elevations in bilirubin and transaminases, nausea, peripheral neuropathy, and hyperglycemia, which were managed with supportive care, dose adjustments, and interruptions. Am. J. Hematol. 90:120–124, 2015. © 2014 Wiley Periodicals, Inc.

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