- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00455221
Safety Assessment of a Multipeptide-gene Vaccine in CML
Safety Assessment of a Peptide Vaccine Derived From Bcr-abl Along With Cytokine Genes in CML Patients Undergoing Imatinib Treatment
The primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against CML in patients under Imatinib treatment.
We will also perform some laboratory tests suggesting biological response.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
- Patients will continue to take their current dose of Imatinib.
- Patients will undergo HLA-typing to define the HLA A, B, and DR.
- One constant dose of ten bcr-abl peptides (100μg each) will be administered subcutaneously in all patients triweekly for 8 doses.
- Four different doses of IL-12 and GM-CSF plasmids will be tested in this trial. The plasmids will be administered subcutaneously near the vaccination site 24 hours before vaccination.
- The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial.
- Each vaccination may consist of one to several shots placed under the skin on the forearm, thigh or trunk area, and the sites will rotate per vaccination.
- During the clinic visit for vaccinations, blood tests will be drawn. If, during the course of therapy, side effects develop that the doctor feels pose a threat to the patient, treatment will be stopped.
- Patients will also undergo DTH skin tests before and after vaccination to see if an immune reaction is occurring at the injection site.
- Patients' lymphocytes will be tested before and after vaccination regarding IFN-γ and IL-4 production to assess immune system activation.
During the course of treatment we will measure the effect the vaccine is having on the patients CML every three months by:
- doing a bone marrow biopsy and aspirate analysis, and
- measuring the amount of BCR-ABL that is detectable by RT-PCR in the patients' peripheral blood and bone marrow aspirate.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
-
Tehran, Iran, Islamische Republik, 14114
- Hematology-Oncology & SCT Research Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Patients with Philadelphia chromosome positive CML who are:
- of subtype b3a2
- In first complete hematologic response;
- have received imatinib for > 12 months of which the last 3 months were at a stable dose of at least 400 mg/day;
- have PCR detectable BCR-ABL transcript by qRT-PCR, and
- with persistent disease, as defined by <1 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared with a standardized baseline.
- Greater than or equal to 18 years in age
- No known infection with human immunodeficiency virus
- Physician and patient willingness to maintain the baseline dose of imatinib throughout the study period
- Written informed consent obtained from the patient
Exclusion Criteria:
- Female patients who are pregnant or breast feeding or adults of childbearing age who are not using adequate birth control.
- Current use of systemic immunosuppressive medications
- ALT or AST >3X Upper limit Normal
- Prior allogeneic stem cell transplantation
- Other experimental therapy within the past two months
- Prior participation in vaccine studies within the past six months
- Oxygen saturation of less than 95% at room air
- History of recent acute myocardial infarction, unstable angina, or pulmonary decompensation requiring hospitalization within the past 3 months.
- Concurrent and or uncontrolled psychiatric or medical condition which may interfere with the study completion.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Peptide Vaccine
|
The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids.
If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid.
If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids.
If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids.
Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial
Cytokine gene adjuvant
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients
Zeitfenster: At enroll in study and 3 months after intervention
|
At enroll in study and 3 months after intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
To measure the development of a molecular response to vaccination as measured by 1 log decrease in qRT-PCR BCR-ABL levels for at least 3 months; To measure the development of immune response following vaccination
Zeitfenster: At enroll in study and 3 months after intervention
|
At enroll in study and 3 months after intervention
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Seyed Hamidollah Ghaffari, PhD, Tehran University of Medical Sciences
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 418-A-2209
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Leukämie, myeloisch, chronisch
-
Nanfang Hospital of Southern Medical UniversityPeking University People's Hospital; Guangzhou First People's Hospital; Sun Yat-Sen... und andere MitarbeiterUnbekanntAllogene hämatopoetische Stammzelltransplantation | Bedingungen | Mixed-Lineage-Leukemia (MLL)-Rearranged Acute LeukemiaChina
-
Shenzhen Second People's HospitalRekrutierungLeukämie | Myeloisch | Chronisch | BCR-ABL (Breakpoint Cluster Region-Abelson Murine Leukemia) | PositivChina
-
Michael BurkeChildren's Hospitals and Clinics of MinnesotaBeendet
-
Sunshine Lake Pharma Co., Ltd.Rekrutierung
-
Azienda Ospedaliera Ospedale Infantile Regina Margherita...AbgeschlossenLeukämie, MyeloidItalien
-
Assistance Publique - Hôpitaux de ParisUnbekannt
-
Xuejie JiangRekrutierung
-
The Affiliated Hospital of the Chinese Academy...UnbekanntLeukämie, MyeloidChina
-
Virginia Commonwealth UniversityMassey Cancer CenterAbgeschlossenLeukämie | Myeloid | MonozytenVereinigte Staaten
-
Children's Oncology GroupNational Cancer Institute (NCI)Abgeschlossen
Klinische Studien zur Bcr-abl multipeptide vaccine
-
CepheidAbgeschlossenLeukämie, myeloische, chronischeVereinigte Staaten
-
Gruppo Italiano Malattie EMatologiche dell'AdultoAbgeschlossen
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AbgeschlossenLeukämieVereinigte Staaten
-
Safaa AA KhaledUnbekanntMyeloproliferatives Neoplasma
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)BeendetLeukämieVereinigte Staaten
-
H. Lee Moffitt Cancer Center and Research InstituteIncyte Corporation; H. Jean Khoury Cure CML ConsortiumRekrutierungChronische myeloische Leukämie, chronische Phase | Chronische myeloische Leukämie in der chronischen PhaseVereinigte Staaten
-
University of California, San FranciscoKenya Medical Research InstituteAbgeschlossenGebärmutterhalskrebs | Zervikale intraepitheliale Neoplasie | HIVKenia
-
Chiesi Farmaceutici S.p.A.AbgeschlossenLungenerkrankung, chronisch obstruktivVereinigtes Königreich
-
Daiichi Sankyo, Inc.Abgeschlossen
-
City of Hope Medical CenterNational Cancer Institute (NCI)AbgeschlossenAnaplastisches Astrozytom des Erwachsenen | Anaplastisches Ependymom des Erwachsenen | Erwachsenes anaplastisches Oligodendrogliom | Adultes Riesenzell-Glioblastom | Erwachsenes Glioblastom | Erwachsenes Gliosarkom | Gemischtes Gliom für Erwachsene | Wiederkehrender Hirntumor bei Erwachsenen | Tumore... und andere BedingungenVereinigte Staaten