Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma
Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell.
The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab.
In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV).
The following test and procedures will be performed on Days 1 and 15 of each cycle:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD
After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan Follow up will include the following
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Review and Physical exam
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- CT scans
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Florida
-
Tampa, Florida, Förenta staterna, 33612
- Moffitt Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Förenta staterna, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hosptial
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma
- Non-bulky disease defined as less than 10 cm in maximal diameter
- Measurable disease greater than or equal to 1.5 cm
- ECOG performance status of 0 or 2
- Willing to use 2 effective forms of birth control
Exclusion Criteria:
- No prior chemotherapy or radiotherapy for Hodgkin lymphoma
- Not receiving any other investigational agents
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab
- No pre-existing grade 3 or greater neuropathy
- No uncontrolled intercurrent illness
- Not pregnant or breastfeeding
- No history of a different malignancy unless disease free for at least one year
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment Arm
Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
|
2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Andra namn:
Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Complete Response Rate
Tidsram: End of Therapy (median duration of four months)
|
Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT).
Response is evaluated using Revised International Working Group Criteria.
Complete response is defined as disappearance of all evidence of disease.
|
End of Therapy (median duration of four months)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Response Rate After One Cycle of Brentuximab
Tidsram: 28 days
|
The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.
|
28 days
|
|
Overall Response Rate
Tidsram: End of Therapy (median duration of four months)
|
The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.
|
End of Therapy (median duration of four months)
|
|
Grade III or IV Adverse Events
Tidsram: 2 years
|
A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.
|
2 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Jeremy Abramson, M.D., Massachusetts General Hospital
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom
- Hodgkins sjukdom
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Antineoplastiska medel, fytogena
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Antineoplastiska medel, immunologiska
- Antibiotika, antineoplastiska
- Doxorubicin
- Liposomal doxorubicin
- Dakarbazin
- Brentuximab Vedotin
- Vinblastin
Andra studie-ID-nummer
- 11-462
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