Safety Assessment of a Multipeptide-gene Vaccine in CML
31. maj 2012 opdateret af: Tehran University of Medical Sciences
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
- 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Tehran, Iran, Islamisk Republik, 14114
- Hematology-Oncology & SCT Research Center
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients
Tidsramme: At enroll in study and 3 months after intervention
|
At enroll in study and 3 months after intervention
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: At enroll in study and 3 months after intervention
|
At enroll in study and 3 months after intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Seyed Hamidollah Ghaffari, PhD, Tehran University of Medical Sciences
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2008
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. november 2011
Datoer for studieregistrering
Først indsendt
31. marts 2007
Først indsendt, der opfyldte QC-kriterier
31. marts 2007
Først opslået (Skøn)
3. april 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. juni 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. maj 2012
Sidst verificeret
1. maj 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 418-A-2209
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .