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NCT00025259 · CITED IN SOURCE DOCUMENTS

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2017-04-12

This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Event-free Survival

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outcome · POSTED

Disease Response Assessed by Modified RECIST Criteria

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outcome · POSTED

Grade 3 or 4 Non-hematologic Toxicity

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all histologies) are eligible for this protocol if they meet the following clinical stage guidelines: * All Stage IB regardless of bulk disease * All Stage IIB regardless of bulk disease * Stage IA only with bulk disease * Stage IIA only with bulk disease * All Stage IAE, IIAE regardless of bulk disease * All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease * All Stage IVA, IVAE regardless of bulk disease * May not be staged by laparotomy alone * Surgically staged patients must also have presurgical staging * Bilirubin no greater than 1.5 times normal * SGOT or SGPT less than 2.5 times normal * Creatinine no greater than 1.5 times normal * Creatinine clearance greater than 40 mL/min * Radioisotope glomerular filtration rate greater than 70 mL/min * Shortening fraction at least 27% by echocardiogram * Ejection fraction at least 50% by MUGA * No pathologic prolongation of QTc interval on 12-lead electrocardiogram * FEV\_1/FVC greater than 60% by pulmonary function test * Pulse oximetry greater than 94% * No evidence of dyspnea at rest * No exercise intolerance * Adequate venous access * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior chemotherapy * At least 1 month since prior corticosteroids except prednisone for respiratory distress * No prior radiotherapy
healthy Volunteers
false
maximum Age
21 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.
    intervention Names
    1. Biological: Bleomycin Sulfate
    2. Drug: Cyclophosphamide
    3. Drug: Doxorubicin Hydrochloride
    4. Drug: Etoposide
    5. Biological: Filgrastim
    6. Drug: Prednisone
    7. Drug: Vincristine Sulfate Liposome
    label
    Arm I (Patients off-therapy before callback-Induction only)
    type
    EXPERIMENTAL
  2. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.
    intervention Names
    1. Biological: Bleomycin Sulfate
    2. Drug: Cyclophosphamide
    3. Drug: Doxorubicin Hydrochloride
    4. Drug: Etoposide
    5. Biological: Filgrastim
    6. Radiation: Involved-Field Radiation Therapy
    7. Drug: Prednisone
    8. Drug: Vincristine Sulfate Liposome
    label
    Arm II (RER with CR [ABVE-PC, IFRT])
    type
    EXPERIMENTAL
  3. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.
    intervention Names
    1. Biological: Bleomycin Sulfate
    2. Drug: Cyclophosphamide
    3. Drug: Doxorubicin Hydrochloride
    4. Drug: Etoposide
    5. Biological: Filgrastim
    6. Drug: Prednisone
    7. Drug: Vincristine Sulfate Liposome
    label
    Arm III (RER with CR [ABVE-PC])
    type
    EXPERIMENTAL
  4. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.
    intervention Names
    1. Biological: Bleomycin Sulfate
    2. Drug: Cyclophosphamide
    3. Drug: Doxorubicin Hydrochloride
    4. Drug: Etoposide
    5. Biological: Filgrastim
    6. Radiation: Involved-Field Radiation Therapy
    7. Drug: Prednisone
    8. Drug: Vincristine Sulfate Liposome
    label
    Arm IV (RER with less than CR [ABVE-PC, IFRT])
    type
    EXPERIMENTAL
  5. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.
    intervention Names
    1. Biological: Bleomycin Sulfate
    2. Drug: Cyclophosphamide
    3. Drug: Doxorubicin Hydrochloride
    4. Drug: Etoposide
    5. Biological: Filgrastim
    6. Drug: Prednisone
    7. Drug: Vincristine Sulfate Liposome
    label
    Arm V (RER with PD)
    type
    EXPERIMENTAL
  6. description
    Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, and cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 and 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 and G-CSF SC beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
    intervention Names
    1. Biological: Bleomycin Sulfate
    2. Drug: Cisplatin
    3. Drug: Cyclophosphamide
    4. Drug: Cytarabine
    5. Drug: Dexamethasone
    6. Drug: Doxorubicin Hydrochloride
    7. Drug: Etoposide
    8. Biological: Filgrastim
    9. Radiation: Involved-Field Radiation Therapy
    10. Drug: Prednisone
    11. Drug: Vincristine Sulfate Liposome
    label
    Arm VI (SER [DECA, ABVE-PC, IFRT])
    type
    EXPERIMENTAL
  7. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
    intervention Names
    1. Biological: Bleomycin Sulfate
    2. Drug: Cyclophosphamide
    3. Drug: Doxorubicin Hydrochloride
    4. Drug: Etoposide
    5. Biological: Filgrastim
    6. Radiation: Involved-Field Radiation Therapy
    7. Drug: Prednisone
    8. Drug: Vincristine Sulfate Liposome
    label
    Arm VII (SER [ABVE-PC, IFRT])
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I (Patients off-therapy before callback-Induction only)
    2. Arm II (RER with CR [ABVE-PC, IFRT])
    3. Arm III (RER with CR [ABVE-PC])
    4. Arm IV (RER with less than CR [ABVE-PC, IFRT])
    5. Arm V (RER with PD)
    6. Arm VI (SER [DECA, ABVE-PC, IFRT])
    7. Arm VII (SER [ABVE-PC, IFRT])
    description
    Given IV or SC
    name
    Bleomycin Sulfate
    other Names
    1. Blanoxan
    2. BleMomycine
    3. Blenoxane
    4. Bleo-cell
    5. Bleo-S
    6. Bleocin
    7. Bleolem
    8. Bleomycin Sulfas
    9. Bleomycin Sulphate
    10. Blexane
    11. Oil Bleo
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm VI (SER [DECA, ABVE-PC, IFRT])
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  3. arm Group Labels
    1. Arm I (Patients off-therapy before callback-Induction only)
    2. Arm II (RER with CR [ABVE-PC, IFRT])
    3. Arm III (RER with CR [ABVE-PC])
    4. Arm IV (RER with less than CR [ABVE-PC, IFRT])
    5. Arm V (RER with PD)
    6. Arm VI (SER [DECA, ABVE-PC, IFRT])
    7. Arm VII (SER [ABVE-PC, IFRT])
    description
    Given IV
    name
    Cyclophosphamide
    other Names
    1. (-)-Cyclophosphamide
    2. 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    3. Carloxan
    4. Ciclofosfamida
    5. Ciclofosfamide
    6. Cicloxal
    7. Clafen
    8. Claphene
    9. CP monohydrate
    10. CTX
    11. CYCLO-cell
    12. Cycloblastin
    type
    DRUG
  4. arm Group Labels
    1. Arm VI (SER [DECA, ABVE-PC, IFRT])
    description
    Given IV
    name
    Cytarabine
    other Names
    1. .beta.-Cytosine arabinoside
    2. 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
    3. 1-.beta.-D-Arabinofuranosylcytosine
    4. 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
    5. 1-Beta-D-arabinofuranosylcytosine
    6. 1.beta.-D-Arabinofuranosylcytosine
    7. 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
    8. 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
    9. Alexan
    10. Ara-C
    11. ARA-cell
    12. Arabine
    type
    DRUG
  5. arm Group Labels
    1. Arm VI (SER [DECA, ABVE-PC, IFRT])
    description
    Given IV
    name
    Dexamethasone
    other Names
    1. Aacidexam
    2. Adexone
    3. Aknichthol Dexa
    4. Alba-Dex
    5. Alin
    6. Alin Depot
    7. Alin Oftalmico
    8. Amplidermis
    9. Anemul mono
    10. Auricularum
    11. Auxiloson
    12. Baycuten
    type
    DRUG
  6. arm Group Labels
    1. Arm I (Patients off-therapy before callback-Induction only)
    2. Arm II (RER with CR [ABVE-PC, IFRT])
    3. Arm III (RER with CR [ABVE-PC])
    4. Arm IV (RER with less than CR [ABVE-PC, IFRT])
    5. Arm V (RER with PD)
    6. Arm VI (SER [DECA, ABVE-PC, IFRT])
    7. Arm VII (SER [ABVE-PC, IFRT])
    description
    Given IV
    name
    Doxorubicin Hydrochloride
    other Names
    1. 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    2. ADM
    3. Adriacin
    4. Adriamycin
    5. Adriamycin Hydrochloride
    6. Adriamycin PFS
    7. Adriamycin RDF
    8. ADRIAMYCIN, HYDROCHLORIDE
    9. Adriamycine
    10. Adriblastina
    11. Adriblastine
    12. Adrimedac
    type
    DRUG
  7. arm Group Labels
    1. Arm I (Patients off-therapy before callback-Induction only)
    2. Arm II (RER with CR [ABVE-PC, IFRT])
    3. Arm III (RER with CR [ABVE-PC])
    4. Arm IV (RER with less than CR [ABVE-PC, IFRT])
    5. Arm V (RER with PD)
    6. Arm VI (SER [DECA, ABVE-PC, IFRT])
    7. Arm VII (SER [ABVE-PC, IFRT])
    description
    Given IV
    name
    Etoposide
    other Names
    1. Demethyl Epipodophyllotoxin Ethylidine Glucoside
    2. EPEG
    3. Lastet
    4. Toposar
    5. Vepesid
    6. VP 16-213
    7. VP-16
    8. VP-16-213
    type
    DRUG
  8. arm Group Labels
    1. Arm I (Patients off-therapy before callback-Induction only)
    2. Arm II (RER with CR [ABVE-PC, IFRT])
    3. Arm III (RER with CR [ABVE-PC])
    4. Arm IV (RER with less than CR [ABVE-PC, IFRT])
    5. Arm V (RER with PD)
    6. Arm VI (SER [DECA, ABVE-PC, IFRT])
    7. Arm VII (SER [ABVE-PC, IFRT])
    description
    Given SC
    name
    Filgrastim
    other Names
    1. Filgrastim XM02
    2. G-CSF
    3. Neupogen
    4. r-metHuG-CSF
    5. Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
    6. rG-CSF
    7. Tbo-filgrastim
    8. Tevagrastim
    type
    BIOLOGICAL
  9. arm Group Labels
    1. Arm II (RER with CR [ABVE-PC, IFRT])
    2. Arm IV (RER with less than CR [ABVE-PC, IFRT])
    3. Arm VI (SER [DECA, ABVE-PC, IFRT])
    4. Arm VII (SER [ABVE-PC, IFRT])
    description
    Undergo IFRT
    name
    Involved-Field Radiation Therapy
    other Names
    1. IFRT
    2. Involved field radiotherapy
    type
    RADIATION
  10. arm Group Labels
    1. Arm I (Patients off-therapy before callback-Induction only)
    2. Arm II (RER with CR [ABVE-PC, IFRT])
    3. Arm III (RER with CR [ABVE-PC])
    4. Arm IV (RER with less than CR [ABVE-PC, IFRT])
    5. Arm V (RER with PD)
    6. Arm VI (SER [DECA, ABVE-PC, IFRT])
    7. Arm VII (SER [ABVE-PC, IFRT])
    description
    Given orally
    name
    Prednisone
    other Names
    1. .delta.1-Cortisone
    2. 1, 2-Dehydrocortisone
    3. Adasone
    4. Cortancyl
    5. Dacortin
    6. DeCortin
    7. Decortisyl
    8. Decorton
    9. Delta 1-Cortisone
    10. Delta-Dome
    11. Deltacortene
    12. Deltacortisone
    type
    DRUG
  11. arm Group Labels
    1. Arm I (Patients off-therapy before callback-Induction only)
    2. Arm II (RER with CR [ABVE-PC, IFRT])
    3. Arm III (RER with CR [ABVE-PC])
    4. Arm IV (RER with less than CR [ABVE-PC, IFRT])
    5. Arm V (RER with PD)
    6. Arm VI (SER [DECA, ABVE-PC, IFRT])
    7. Arm VII (SER [ABVE-PC, IFRT])
    description
    Given IV
    name
    Vincristine Sulfate Liposome
    other Names
    1. Marqibo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1734
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.
    measure
    Event-free Survival
    time Frame
    5 years
secondary Outcomes
  1. description
    Number of participants with complete response and very good partial response at the end of protocol therapy.
    measure
    Disease Response Assessed by Modified RECIST Criteria
    time Frame
    Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
  2. description
    Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.
    measure
    Grade 3 or 4 Non-hematologic Toxicity
    time Frame
    Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
  3. description
    Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.
    measure
    Overall Survival
    time Frame
    5 years
Full study description
brief Summary
This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
detailed Description
OBJECTIVES: I. To compare response-based therapy to standard therapy for intermediate risk Hodgkin disease. II. To determine whether involved field radiation therapy (IFRT) can be eliminated based upon early and complete response to multiagent chemotherapy. III. To determine whether the addition of an additional two cycles of chemotherapy (DECA) can improve outcome in those with a slow early response to standard chemotherapy. IV. To prospectively collect information on the individual prognostic significance of the following presenting factors: erythrocyte sedimentation rate, circulating levels of IL-10, each of the "B" symptoms - fever, night sweats, weight loss, nodal aggregate \> 6 cm, large mediastinal mass \> 1/3 thoracic diameter and number of involved nodal sites, histology, albumin, blood counts, sex and age. V. To study the reliability and utility of \[18F\] -Fluorodeoxyglucose (FDG) Imaging (PET scans) as an imaging modality in Hodgkin disease. VI. To determine the frequency and severity of late effects of therapy including thyroid dysfunction, infertility, cardiotoxicity, pulmonary toxicity and second malignant neoplasms. VII. To serve as the therapeutic companion to biology studies in Hodgkin disease and correlate those results with response to therapy, event free-survival and overall survival. OUTLINE: This is a randomized, multicenter study. ARM I (ALL PATIENTS-OFF THERAPY BEFORE CALLBACK-INDUCTION CHEMOTHERAPY \[ABVE-PC\]): Patients receive doxorubicin intravenously (IV) over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or subcutaneously (SC) and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. At the end of initial chemotherapy, patients undergo evaluation for response. Patients with less than 60% disease reduction are considered to have slow early response (SER). Patients with 60% or more disease reduction are considered to have rapid early response (RER). RER: Patients receive 2 additional courses of ABVE-PC chemotherapy. After completion of treatment, patients are randomized to 1 of 4 treatment arms. ARM II: Patients with sustained complete response (CR) undergo involved field radiation therapy (IFRT) approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. ARM III: Patients with sustained CR receive no further treatment. ARM IV: Patients with very good partial response (VGPR), partial response (PR) or stable disease (SD) undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. ARM V: Patients with progressive disease are taken off therapy and treated their physician's discretion. SER: Patients are randomized to 1 of 2 treatment arms. ARM VI: Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, cytarabine IV over 3 hours on days 1-2, and receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 and 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 and G-CSF SC beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After these 2 courses, patients then receive 2 additional courses of ABVE-PC chemotherapy. ARM VII: Patients receive 2 courses of ABVE-PC chemotherapy. In both SER arms, patients with sustained CR or PR undergo IFRT approximately 3 weeks after the last course of chemotherapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Source references
references
  1. citation
    Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
    pmid
    40135712
    type
    DERIVED
  2. citation
    Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28.
    pmid
    37505794
    type
    DERIVED
  3. citation
    Johnston RL, Mottok A, Chan FC, Jiang A, Diepstra A, Visser L, Telenius A, Gascoyne RD, Friedman DL, Schwartz CL, Kelly KM, Scott DW, Horton TM, Steidl C. A gene expression-based model predicts outcome in children with intermediate-risk classical Hodgkin lymphoma. Blood. 2022 Feb 10;139(6):889-893. doi: 10.1182/blood.2021011941.
    pmid
    34662378
    type
    DERIVED
  4. citation
    Giulino-Roth L, Pei Q, Buxton A, Bush R, Wu Y, Wolden SL, Constine LS, Kelly KM, Schwartz CL, Friedman DL. Subsequent malignant neoplasms among children with Hodgkin lymphoma: a report from the Children's Oncology Group. Blood. 2021 Mar 18;137(11):1449-1456. doi: 10.1182/blood.2020007225.
    pmid
    33512412
    type
    DERIVED
  5. citation
    Welch JJG, Schwartz CL, Higman M, Chen L, Buxton A, Kanakry JA, Kahwash SB, Hutchison RE, Friedman DL, Ambinder RF. Epstein-Barr virus DNA in serum as an early prognostic marker in children and adolescents with Hodgkin lymphoma. Blood Adv. 2017 Apr 24;1(11):681-684. doi: 10.1182/bloodadvances.2016002618. eCollection 2017 Apr 25.
    pmid
    29296710
    type
    DERIVED
  6. citation
    Friedman DL, Chen L, Wolden S, Buxton A, McCarten K, FitzGerald TJ, Kessel S, De Alarcon PA, Chen AR, Kobrinsky N, Ehrlich P, Hutchison RE, Constine LS, Schwartz CL. Dose-intensive response-based chemotherapy and radiation therapy for children and adolescents with newly diagnosed intermediate-risk hodgkin lymphoma: a report from the Children's Oncology Group Study AHOD0031. J Clin Oncol. 2014 Nov 10;32(32):3651-8. doi: 10.1200/JCO.2013.52.5410. Epub 2014 Oct 13.
    pmid
    25311218
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-6b76c171e995df5336dc
      requested nct id
      NCT00025259
      primary nct id
      NCT00025259
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      bad667e8b37974c2eea779647c1a36ebd0b7bf2bd21d80932a43fbbfa970b044
      payload sha256
      792807e639aa64148def45cb552d2792d4c5cca9f3ed5d99b1bffb25266107c6
      payload
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        ted with adverse outcome, many of which are collinear, were evaluated by multivariable analysis in the Children's Oncology Group (COG) <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a> trial for 1,734 children with intermediate-risk Hodgkin lymphoma. The most robust predictors of outcome in this homogeneously treat
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        e, many of which are collinear, were evaluated by multivariable analysis in the Children's Oncology Group (COG) <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a> trial for 1,734 children with intermediate-risk Hodgkin lymphoma. The most robust predictors of outcome in this homogeneously treated cohort were stage IV
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        PP cycles. The 5-year EFS rate among the cohort was 94% (median follow-up, 6.3 years).</li></ul></div></li></ol></div></li><li>The COG <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a>, <a href="/clinicaltrials/NCT01026220">AHOD0831 (NCT01026220)</a>, and <a href="/clinicaltrials/NCT00302003">AHOD0431 (NCT00302003)
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        FS rate among the cohort was 94% (median follow-up, 6.3 years).</li></ul></div></li></ol></div></li><li>The COG <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a>, <a href="/clinicaltrials/NCT01026220">AHOD0831 (NCT01026220)</a>, and <a href="/clinicaltrials/NCT00302003">AHOD0431 (NCT00302003)</a> trials also used i
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        NCT00025259
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        uent neoplasm.</li></ul></div></li><li>In a retrospective analysis, 97 intermediate-risk patients with NLPHL were treated in COG study <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a>.[<a href="#cit/section_6.36">36</a>]<div class="pdq-content-list"><ul id="_1871"><li>These patients demonstrated a higher CR rate t
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        ></div></li><li>In a retrospective analysis, 97 intermediate-risk patients with NLPHL were treated in COG study <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a>.[<a href="#cit/section_6.36">36</a>]<div class="pdq-content-list"><ul id="_1871"><li>These patients demonstrated a higher CR rate than patients with class
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        207629
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        ne therapy.[<a href="#cit/section_6.24">24</a>]</p><p id="_1874" tabindex="-1"> However, the intermediate-risk Hodgkin lymphoma study (<a href="/clinicaltrials/NCT00025259">AHOD0031 [NCT00025259]</a>) did not show a benefit for IFRT in patients who achieved a rapid CR to chemotherapy (defined as &gt;60% reduction in 2-dimensional
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        225789
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        NCT00025259
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        it/section_6.24">24</a>]</p><p id="_1874" tabindex="-1"> However, the intermediate-risk Hodgkin lymphoma study (<a href="/clinicaltrials/NCT00025259">AHOD0031 [NCT00025259]</a>) did not show a benefit for IFRT in patients who achieved a rapid CR to chemotherapy (defined as &gt;60% reduction in 2-dimensional tumor burden after two
        end
        225812
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        NCT00025259
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        four cycles of VAMP chemotherapy plus 25.5 Gy IFRT (89% vs. 88%).[<a href="#cit/section_6.71">71</a>]</li></ul></div></li><li>The COG <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a> study enrolled 1,712 patients in a randomized controlled trial to evaluate the role of early chemotherapy response in tailoring su
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        emotherapy plus 25.5 Gy IFRT (89% vs. 88%).[<a href="#cit/section_6.71">71</a>]</li></ul></div></li><li>The COG <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a> study enrolled 1,712 patients in a randomized controlled trial to evaluate the role of early chemotherapy response in tailoring subsequent therapy in ped
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        ></ul></div><p id="_1945" tabindex="-1">An analysis of patterns of failure among patients whose disease relapsed while enrolled in the <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a> study demonstrated that first relapses occurred more often within the previously irradiated field and within initially involved sit
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        249668
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        5" tabindex="-1">An analysis of patterns of failure among patients whose disease relapsed while enrolled in the <a href="/clinicaltrials/NCT00025259">AHOD0031 (NCT00025259)</a> study demonstrated that first relapses occurred more often within the previously irradiated field and within initially involved sites of disease, includin
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        Updated: April 16, 2025
        datetime
        2025-04-16T12:00:00Z
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        April 16, 2025

    Preserved source evidence · Not medical advice