- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00720603
This is a Multi-center, Single Arm, Open Label Study Intended to Provide Expanded Access to Plerixafor for Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) Who Are to Receive Treatment With an Autologous Peripheral Stem Cell Transplant. (EAP)
19 marzo 2015 aggiornato da: Genzyme, a Sanofi Company
Expanded Acess Study of Plerixafor and G-CSF for the Mobilization and Collection of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease or Multiple Myeloma
The purpose of this program is to provide expanded access to plerixafor for patients with NHL, HD, or MM who are to receive treatment with an autologous peripheral stem cell transplant.
Panoramica dello studio
Stato
Non più disponibile
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The Expanded Access Program (EAP)(protocol number MOZ00607) is an open label study intended to provide access to plerixafor for patients with non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma who are to receive treatment with an autologous hematopoietic stem cell transplant.
Patients who have previously failed stem cell mobilization attempts or who have previously received an autologous or allogeneic stem cell transplant are not eligible to enroll in this program.
The standard of care regimen for stem cell mobilization includes a growth factor, G-CSF, to increase peripheral blood stem cells.
Plerixafor is given on the evening prior to doses of standard treatment with G-CSF.
The combination of G-CSF and plerixafor has the potential to increase the number of circulating stem cells.
The stem cells develop into specialized white blood cells and platelets that are necessary for immune system function and normal blood clotting.
The stem cells are removed by a process called apheresis, in which blood is drawn from the patient, the stem cells are separated from the plasma, and the plasma is returned to the patient.
The separated stem cells are frozen, similar to the blood banking process.
The patient then receives chemotherapy according to the institutional standard.
After chemotherapy, stem cell transplant is intended to replenish cells in the bone marrow that may be destroyed by chemotherapy.
Tipo di studio
Accesso esteso
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
N/A
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Diagnosis of MM, NHL, or HD.
- Eligible for a planned autologous peripheral stem cell transplantation.
- Written informed consent.
- At least 18 years of age (inclusive).
- Easter Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, I.e., eligible by institutional standards for autologous stem cell transplant.
- Male and female patients of childbearing potential agree to use appropriate form of contraception (i.e., condom, diaphragm cervical cap, etc.) while on study and for at least 3 months following the last treatment. Female patients of child-producing potential must have a negative serum pregnancy test confirmed within 7 days of beginning mobilization therapy.
- White blood cell (WBC) count greater than or equal to 2.5x10^9/L.
- Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L.
- Platelet count greater than or equal to 100x10^9/L.
- Serum creatinine less than or equal to 2.2 mg/ dL.
- AST/SGOT, ALT/SGPT, and total bilirubin less than 2.5 x upper limit of normal (ULN).
Exclusion Criteria:
- History of acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), acute myelocytic leukemia (AML), chronic myelocytic leukemia (CML), myelodysplastic syndrome (MDS), plasma cell leukemia or other leukemia.
- Failed previous CD34+ cell collection attempts.
- Prior autologous or allogenic transplantation.
- less than 4 weeks since last anti-cancer therapy (including chemotherapy, biologic/immunologic, radiation) or less than 6 weeks if prior therapy was with nitrosourea or mitomycin (for therapies with prolonged effects, a treatment-free interval of at least 2 half-lives should be considered) with the exception of the following: Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or bortezomib (Velcade®) is allowed up to 7 days prior to the first dose of G-CF.
- Bone marrow involvement greater than 20% assessed based on the most recent bone marrow aspirate or biopsy.
- Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization.
- HIV positive.
- Active hepatitis B (positive HBsAg) or hepatitis C.
- Acute infection (febrile, i.e., temperature greater than 38 degrees Celsius/100.4 degrees Fahrenheit) within 24 hours prior to dosing or antibiotic therapy within 1 week of enrollment.
- Hypercalcemia as evidenced by greater than 1 mg/dL above ULN.
- Previously received investigational therapy with 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilization phase.
- Central nervous system involvement including brain metastases of leptomeningeal disease.
- Pregnant or nursing women.
- ECG or study result (exercize study, scan) indicative of previously undiagnosed cardiac ischemia or a history of clinically significant rhythm disturbance (arrhythmias), or other conduction abnormality in the last year that in the opinion of the Investigator warrants exclusion of the subject from the trial.
- Co-morbid conditions(s), which in the opinion of the Investigator, renders the patient at high risk from treatment complications or impairs their ability to comply with the study treatment and protocol.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Date di iscrizione allo studio
Primo inviato
21 luglio 2008
Primo inviato che soddisfa i criteri di controllo qualità
22 luglio 2008
Primo Inserito (Stima)
23 luglio 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
24 marzo 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 marzo 2015
Ultimo verificato
1 marzo 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Linfoma
- Mieloma multiplo
- Neoplasie, plasmacellule
- Malattia di Hodgkin
- Linfoma non Hodgkin
- Agenti antinfettivi
- Agenti antivirali
- Agenti anti-HIV
- Agenti antiretrovirali
- Plerixafor
Altri numeri di identificazione dello studio
- MOZ00607
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .