Parly, France
Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
Phase
2Span
146 weeksSponsor
Biofabri, S.LJerez de la Frontera
Recruiting
Niraparib with BeVAcizumab After Complete CytoreductioN in Patients with OvArian Cancer
Phase II, randomized, open label, multicenterstudy. Randomization on a 1:1 ratio, stratification performed according to: BRCA status (local assessment) FIGO stage at diagnosis (IIIA versus IIIB/IIIC) Previous hyperthermic intraperitoneal chemotherapy (yes/no).
Phase
2Span
422 weeksSponsor
ARCAGY/ GINECO GROUPJerez de la Frontera
Recruiting
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP. The date of maintenance treatment initiation will be considered the index date (see definition of maintenance treatment initiation in Section 3.1). Baseline data will be collected immediately after the inclusion of the patient in the study (including retrospective data from the index date to the date of informed consent and from the past 5 years). From the index date, each patient will be followed up until discontinuation of the maintenance treatment of interest and up to a maximum of 12 months. Especially after the implementation of the Global Amendment nº1, it is possible that the complete follow-up of the patient took place in the past (retrospective data), i.e. before the inclusion of the subject in the study. Data will be collected from the patient file and from information obtained during routine visits scheduled according to clinical practice.
Phase
N/ASpan
134 weeksSponsor
Otsuka Pharmaceutical Europe LtdJerez de la Frontera
Recruiting
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
Phase
1Span
564 weeksSponsor
Tesaro, Inc.Jerez de la Frontera
Recruiting
PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml / day. allopurinol 300 mg / day. gastric protection (as center). daily monitoring of blood glucose daily monitoring of renal function. Intrathecal treatment (diagnosis and prophylactic / therapeutic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge. Remission induction : Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction. Systemic treatment - Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22. - Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23. Intrathecal chemotherapy Triple therapy was administered with methotrexate (MTX), cytosine arabinoside (ARA-C) and hydrocortisone, days 1, 8, 15 and 22 (five doses total prophylactic between prephase and induction): MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg If initial infiltration of the CNS is administered once every 72 hours until the disappearance of blast cell morphology CSF (cytocentrifugation) in at least two consecutive taps. Alternatively be administered liposomal cytarabine (DepoCyt) fortnightly if authorized by the center or in the context of a clinical trial Maintenance treatment of first year : Maintenance during the first year will start after full recovery after induction and after complete reassessment of the disease (including myelogram) and will last until one year from the time of documentation of complete remission. The basic treatment to include mercaptopurine 50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly. Once every 3 months will be added to maintenance treatment a "mini-reinduction" consisting - VCR: 1 mg (absolute dose), i.v., day 1. - Dexamethasone 40 mg / day, i.v. or p.o., days 1-2. - Not considered more doses of triple intrathecal therapy. Reinduction only be practiced during the first year after remission, so a total of 4 quarterly. Maintenance of the second year: After the first year of maintenance will perform a complete reassessment of the disease (including myelogram) and if the patient remains in complete remission maintenance will continue (without reinduction) until two years from the time of diagnosis. The initial dose of mercaptopurine and methotrexate will be identical to the first year. Must comply (by increases or decreases of 20% of the dose) to maintain the numbers of neutrophil counts between 1.5 and 3x109/l and platelets above 100x109 / L
Phase
4Span
661 weeksSponsor
PETHEMA FoundationJerez de la Frontera
Recruiting
Chemotherapy and Imatinib in Young Adults With Acute Lymphoblastic Leukemia Ph (BCR-ABL) POSITIVE
Induction Chemotherapy - Vincristine (VCR): 1.5 mg/m2 (maximum dose 2 mg) iv days 1, 8, 15 and 22 - daunorubicin (DNR) 45 mg/m2 i.v. days 1, 8, 15 and 22 - Prednisone (PDN): 60 mg/m2 per day, i.v. or p.o., days 1-27 - Imatinib 600 mg p.o. from day 1 until the beginning of the consolidation. Important Note: The administration of imatinib be initiated as soon as the outcome of cytogenetic and molecular study, which will be known under normal conditions during prophase consolidation Patients should be in RC and shall be a minimum of 2 weeks of finding it. Patients did not discontinue treatment with imatinib during this period. Minimum counts to start the consolidation are: neutrophils> 1x109 / L and platelets> 100x109 / L. - Mercaptopurine (MP) 50 mg/m2, p.o. days 1 to 7, 28 to 35 and 56 to 63 - MTX: 1.5 g/m2, i.v. continuous infusion for 24 hours on days 1, 28 and 56. - VP-16: 100 mg/m2 every 12 hours, i.v. (1 hour infusion) on days 14 and 42 - ARA-C: 1000 mg/m2 every 12 hours, i.v. (3-hour infusion) days 14-15 and 42-43 - triple intrathecal treatment days 1, 28 and 56 - Imatinib 600 mg / d po, from day 1 to 15 days before the TPH. During consolidation therapy is recommended in primary prophylaxis with G-CSF or found neutropenia (<0.5 x109 / L). This factor was administered daily until the neutrophil count is > 1x109 / L in two consecutive measurements. Alternatively, PEG-filgrastim can be used (eg 16 and 44), at the discretion of each center Allogenic THP or Autologous TPH
Phase
4Span
783 weeksSponsor
PETHEMA FoundationJerez de la Frontera
Recruiting
A Growth Artificial Intelligence Algorithm for leNgth and Weight Study
Phase
N/ASpan
63 weeksSponsor
Nutricia ResearchJerez de la Frontera
Recruiting
Healthy Volunteers
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Phase
3Span
575 weeksSponsor
Janssen Research & Development, LLCJerez de la Frontera
Recruiting
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
Phase
3Span
364 weeksSponsor
Janssen Research & Development, LLCJerez de la Frontera
Recruiting
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Phase
3Span
440 weeksSponsor
Janssen Research & Development, LLCJerez de la Frontera
Recruiting