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Adcetris (Brentuximab Vedotin), skojarzona chemioterapia i radioterapia w leczeniu młodszych pacjentów z chłoniakiem Hodgkina w stadium IIB, IIIB i IV

11 listopada 2026 zaktualizowane przez: St. Jude Children's Research Hospital

Adcetris (Brentuximab Vedotin), zastąpienie winkrystyny w schemacie OEPA/POChPac [grupa lecznicza 3 (TG3) Euro-Net C1] z radioterapią zajętych węzłów chłoniaka Hodgkina u dzieci wysokiego ryzyka (HL)

This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

PRIMARY OBJECTIVES:

To evaluate the safety of brentuximab vedotin, etoposide, prednisone and doxorubicin hydrochloride (AEPA)/cyclophosphamide, brentuximab vedotin, prednisone and dacarbazine (CAPDac), as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high risk patients with Hodgkin lymphoma (HL).
To compare the event-free survival in high risk HL patients treated with AEPA/CAPDac to the historical control unfavorable risk 2 arm (UR2) of the St. Jude HOD99 study.

SECONDARY OBJECTIVES:

To estimate the number of patients with adequate response according to the definitions in the Euro-Net C1 after 2 cycles of AEPA.
To evaluate the safety of Adcetris (brentuximab vedotin) in the AEPA/CAPDac regimen in children with high risk HL.
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
To study the association between local failure and original lymph node region and volume of radiation (patterns of treatment failure).
To assess patient-reported symptoms and health-related quality of life in children with high risk HL compared to those treated on the unfavorable treatment arm of the St. Jude HOD99 study.

OUTLINE:

AEPA REGIMEN: Patients receive brentuximab vedotin on days 1, 8, and 15, etoposide on days 1 to 5, prednisone three times daily (TID) on days 1 to 15, and doxorubicin hydrochloride on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

CAPDac REGIMEN: Patients receive cyclophosphamide on days 1 and 8, brentuximab vedotin days 1 and 8, prednisone TID on days 1 to 15, and dacarbazine on days 1 to 3. Treatment repeats every 21-28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Beginning 2-3 weeks after CAPDac chemotherapy, patients with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy undergo radiation therapy daily, 5 days a week for 3-4 weeks.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

Faza

Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Stany Zjednoczone
- California
  - Palo Alto, California, Stany Zjednoczone, 94304
    - Lucile Packard Children's Hospital Stanford University
- Illinois
  - Peoria, Illinois, Stany Zjednoczone, 61637
    - St. Jude Midwest Affiliate
- Maine
  - Scarborough, Maine, Stany Zjednoczone, 04704
    - Maine Children's Cancer Program (MCCP)
- Massachusetts
  - Boston, Massachusetts, Stany Zjednoczone, 02114
    - Massachusetts General Hospital Cancer Center
  - Boston, Massachusetts, Stany Zjednoczone, 02115
    - Dana-Farber Harvard Cancer Center
- Tennessee
  - Memphis, Tennessee, Stany Zjednoczone, 38105
    - St. Jude Children's Research Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Nie starszy niż 18 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment).
Age ≤ 18 years at the time of diagnosis (i.e., participants are eligible until their 19th birthday).
Ann Arbor stage IIB, IIIB, IVA, or IVB.
Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinine adjusted for age and gender.
Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x ULN for age).
Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.

Exclusion Criteria:

CD30 negative HL.
Has received prior therapy for Hodgkin lymphoma, except as noted above.
Inadequate organ function as described above.
Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Nie dotyczy
Model interwencyjny: Zadanie dla jednej grupy
Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm Grupa uczestników / Arm Grupa lub podgrupa uczestników badania klinicznego, którzy zgodnie z protokołem badania otrzymują określoną interwencję/leczenie lub nie otrzymują żadnej interwencji.	Interwencja / Leczenie Interwencja / Leczenie Proces lub działanie będące przedmiotem badania klinicznego. Interwencje obejmują leki, urządzenia medyczne, procedury, szczepionki i inne produkty, które są w fazie badań lub są już dostępne. Interwencje mogą również obejmować podejścia nieinwazyjne, takie jak edukacja lub modyfikacja diety i ćwiczeń.
Eksperymentalny: Treatment Participants receive AEPA regimen (brentuximab vedotin, etoposide, prednisone, doxorubicin), and CAPDac regimen (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine(R)). Filgrastim may be given as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. Some participants may volunteer to complete the quality of life assessment.	Lek: brentuximab vedotin Given intravenously (IV). Inne nazwy: SGN-35 Adcetris(R) Lek: etoposide Given IV. Inne nazwy: VP-16 Vepesid(R) Lek: prednisone Given orally (PO). Inne nazwy: prednizolon Lek: doxorubicin Given IV. Inne nazwy: Adriamycyna(R) Lek: cyclophosphamide Given IV. Inne nazwy: Cytoksan(R) Lek: Dacarbazine(R) Given IV. Inne nazwy: Dimetylotriazenoimidazolokarboksyimid (DTIC) Lek: filgrastim Given subcutaneously (SQ) as clinically indicated. Inne nazwy: Neupogen(R) Inny: quality of life assessment Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant. Promieniowanie: radiation therapy At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission. Inne nazwy: naświetlanie promieniowanie radioterapia

Grupa uczestników / Arm

Interwencja / Leczenie

Eksperymentalny: Treatment

Participants receive AEPA regimen (brentuximab vedotin, etoposide, prednisone, doxorubicin), and CAPDac regimen (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine(R)). Filgrastim may be given as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. Some participants may volunteer to complete the quality of life assessment.

Lek: brentuximab vedotin

Given intravenously (IV).

Inne nazwy:

SGN-35
Adcetris(R)

Lek: etoposide

Given IV.

Inne nazwy:

VP-16
Vepesid(R)

Lek: prednisone

Given orally (PO).

Inne nazwy:

prednizolon

Lek: doxorubicin

Given IV.

Inne nazwy:

Adriamycyna(R)

Lek: cyclophosphamide

Given IV.

Inne nazwy:

Cytoksan(R)

Lek: Dacarbazine(R)

Given IV.

Inne nazwy:

Dimetylotriazenoimidazolokarboksyimid (DTIC)

Lek: filgrastim

Given subcutaneously (SQ) as clinically indicated.

Inne nazwy:

Neupogen(R)

Inny: quality of life assessment

Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant.

Promieniowanie: radiation therapy

At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission.

Inne nazwy:

naświetlanie
promieniowanie
radioterapia

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control Ramy czasowe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)	To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.	After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control Ramy czasowe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)	To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.	After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Complete Response Rate Estimate for All Evaluable Participants Ramy czasowe: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)	To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL).	After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2). Ramy czasowe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)	Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2).	From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac. Ramy czasowe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)	The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).	From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
Descriptive of Hematological Adverse Events Ramy czasowe: From enrollment to end of therapy (approximately 8 months)	To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.	From enrollment to end of therapy (approximately 8 months)
Descriptive of Infectious Adverse Events Ramy czasowe: From enrollment to end of therapy (approximately 8 months)	To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.	From enrollment to end of therapy (approximately 8 months)
Descriptive of Neuropathic Adverse Events Ramy czasowe: From enrollment to end of therapy (approximately 8 months)	To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.	From enrollment to end of therapy (approximately 8 months)
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) Ramy czasowe: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)	Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 3. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) Ramy czasowe: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)	Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 4. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
Response Rate Ramy czasowe: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)	Response compared to the Euro-Net C1 after 2 cycles of AEPA.	after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Patient Quality of Life (QoL) Ramy czasowe: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).	Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).
Parent Proxy Quality of Life (QoL) Ramy czasowe: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)	Parent's assessment of child's physical, emotional, social and school functioning over multiple time points. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points Ramy czasowe: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)	The correlation of agreement between patient and parent Quality of Life is calculated by using the Pearson's Correlation Coefficient, which considers only the record with both parent and patient data. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

St. Jude Children's Research Hospital

Współpracownicy

Seagen Inc.

Śledczy

Główny śledczy: Matt Ehrhardt, MD, St. Jude Children's Research Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

12 sierpnia 2013

Zakończenie podstawowe (Rzeczywisty)

16 listopada 2020

Ukończenie studiów (Szacowany)

1 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

6 sierpnia 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 sierpnia 2013

Pierwszy wysłany (Szacowany)

12 sierpnia 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

HLHR13
NCI-2013-01123 (Identyfikator rejestru: NCI Clinical Trial Registration Program)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Adcetris (Brentuximab Vedotin), skojarzona chemioterapia i radioterapia w leczeniu młodszych pacjentów z chłoniakiem Hodgkina w stadium IIB, IIIB i IV

Adcetris (Brentuximab Vedotin), zastąpienie winkrystyny ​​w schemacie OEPA/POChPac [grupa lecznicza 3 (TG3) Euro-Net C1] z radioterapią zajętych węzłów chłoniaka Hodgkina u dzieci wysokiego ryzyka (HL)

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Szczegółowy opis

Typ studiów

Zapisy (Rzeczywisty)

Faza

Kontakty i lokalizacje

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Płeć kwalifikująca się do nauki

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Opis środka

Ramy czasowe

Współpracownicy i badacze

Sponsor

Współpracownicy

Śledczy

Publikacje i pomocne linki

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

Zakończenie podstawowe (Rzeczywisty)

Ukończenie studiów (Szacowany)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Szacowany)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Bada produkt urządzenia regulowany przez amerykańską FDA

Adcetris (Brentuximab Vedotin), zastąpienie winkrystyny w schemacie OEPA/POChPac [grupa lecznicza 3 (TG3) Euro-Net C1] z radioterapią zajętych węzłów chłoniaka Hodgkina u dzieci wysokiego ryzyka (HL)