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AzTrials

Childhood Nodular Lymphocyte Predominant Hodgkin LymphomaPhase 3NCT01026220

Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

A Phase 3 study testing bleomycin sulfate, doxorubicin hydrochloride and liposomal vincristine sulfate in people with Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma and Stage III Childhood Hodgkin Lymphoma, run by Children's Oncology Group at 177 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from… Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
bleomycin sulfate, doxorubicin hydrochloride and liposomal vincristine sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
177 sitesin 5 countries
Study dates
7 Dec 2009to 31 Mar 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the following criteria:
  • Classical disease
  • Nodular lymphocyte-predominant disease
  • Stage III or IV disease with B symptoms, as defined by ≥ 1 of the following:
  • Unexplained weight loss > 10% within the past 6 months
  • Unexplained recurrent fever > 38°C within the past month
Show all 33Show fewer
  • Recurrent drenching night sweats within the past month
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:
  • 0.4 mg/dL (1 to 5 months)
  • 0.5 mg/dL (6 to 11 months)
  • 0.6 mg/dL (12 to 23 months)
  • 0.8 mg/dL (2 to 5 years)
  • 1 mg/dL (6 to 9 years)
  • 1.2 mg/dL (10 to 12 years)
  • 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)
  • 1.7 mg/dL (males) or 1.4 mg/dL (females) (≥ 16 years)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • AST or ALT < 2.5 times ULN for age
  • Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by MUGA (unless due to large mediastinal mass from HL)
  • FEV_1/FVC > 60% by pulmonary function tests (PFT) (unless due to large mediastinal mass fromHL)
  • For children who are unable to cooperate for PFTs, the criteria are:
  • No evidence of dyspnea at rest
  • No exercise intolerance
  • Pulse oximetry > 92% on room air
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No pathologic prolongation of QTc interval (> 450 milliseconds) on 12-lead ECG
  • No prior chemotherapy, biological response modifiers (e.g., monoclonal antibody therapy), or radiotherapy
  • At least 28 days since prior corticosteroids except for emergent treatment for respiratory distress or spinal cord compression, or for treatment of allergy to contrast agent required for CT scan
  • No other concurrent cancer chemotherapy or immunomodulating agents (including steroids)
  • Concurrent corticosteroid therapy as treatment or prophylaxis for anaphylactic reactions allowed
  • No concurrent pegfilgrastim

Who cannot join

None listed.

Trial locations and contacts

177 sites in 5 countries.

177 sites in 5 countries

United States156 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia, 30322

  • Georgia Regents University

    Augusta, Georgia, 30912

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Vermont

    Burlington, Vermont, 05401

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston

    Charleston, West Virginia, 25304

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • T C Thompson Children's Hospital

    Chattanooga, Tennessee, 37403

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Columbia Regional

    Columbia, Missouri, 65201

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Palmetto Health Richland

    Columbia, South Carolina, 29203

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Dayton Children's Hospital

    Dayton, Ohio, 45404

  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

    Denver, Colorado, 80218

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Southern California Permanente Medical Group

    Downey, California, 90242

  • City of Hope Medical Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Michigan State University Clinical Center

    East Lansing, Michigan, 48824-7016

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Lee Memorial Health System

    Fort Myers, Florida, 33901

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • Helen DeVos Children's Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

  • Greenville Cancer Treatment Center

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17033

  • Memorial Healthcare System - Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Services

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Nemours Children's Clinic - Jacksonville

    Jacksonville, Florida, 32207

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Kalamazoo Center for Medical Studies

    Kalamazoo, Michigan, 49008

  • The Childrens Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Miller Children's Hospital

    Long Beach, California, 90806

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Children's Hospital Central California

    Madera, California, 93636-8762

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

  • University of Minnesota Medical Center-Fairview

    Minneapolis, Minnesota, 55455

  • University of South Alabama

    Mobile, Alabama, 36604

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • UMDNJ - Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

  • Yale University

    New Haven, Connecticut, 06520

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    New Hyde Park, New York, 11040

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Children's Hospital-Main Campus

    New Orleans, Louisiana, 70118

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Childrens Hospital-King's Daughters

    Norfolk, Virginia, 23507

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois, 60453

  • Children's Hospital and Research Center at Oakland

    Oakland, California, 94609-1809

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Childrens Hospital of Orange County

    Orange, California, 92868-3874

  • Florida Hospital

    Orlando, Florida, 32803

  • Nemours Children's Clinic - Orlando

    Orlando, Florida, 32806

  • UF Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • Advocate Lutheran General Hospital.

    Park Ridge, Illinois, 60068

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61602

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Children's Oncology Group

    Philadelphia, Pennsylvania, 19104

  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • University of California at Davis Cancer Center

    Sacramento, California, 95817

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123

  • University of California San Francisco Medical Center-Parnassus

    San Francisco, California, 94143

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93102

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Overlook Hospital

    Summit, New Jersey, 07902

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington, 98405

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Saint Joseph Children's Hospital of Tampa

    Tampa, Florida, 33607

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490

  • The Toledo Hospital/Toledo Children's Hospital

    Toledo, Ohio, 43606

  • New York Medical College

    Valhalla, New York, 10595

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Lombardi Comprehensive Cancer Center at Georgetown University

    Washington D.C., District of Columbia, 20057

  • Saint Mary's Hospital

    West Palm Beach, Florida, 33407

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada13 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • IWK Health Centre

    Halifax, Nova Scotia, B3J 3G9

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, H3H 1P3

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre Hospitalier Universitaire de Quebec

    Ste-Foy, Quebec, G1V 4G2

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia5 sites

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Women's and Children's Hospital-Adelaide

    North Adelaide, South Australia, 5006

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6008

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031

Other trials in Australia

Israel2 sites

  • Schneider Children's Medical Center of Israel

    Petah Tikua, 49202

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Puerto Rico1 site

  • San Jorge Children's Hospital

    San Juan, 00912

Other trials in Puerto Rico

About this study

Official title: A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma

This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy 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 combination chemotherapy together with radiation therapy may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To maintain the overall survival (as defined by 4-year "second-event" free survival) for subjects with high risk Hodgkin lymphoma at or above 95%.

SECONDARY OBJECTIVES:

  1. To maintain 3-year event-free survival for subjects with high risk Hodgkin lymphoma at or above 93%.

II. To maintain comparable overall survival (as defined by 4-year "second-event" free survival) between subjects with high risk Hodgkin lymphoma who have a rapid or slow response to the initial 2 cycles of ABVE-PC* by intensifying therapy through the addition of 2 cycles of ifosfamide/vinorelbine in those with a slow early response.

III. To investigate whether very early response assessment measured by FDG-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.

IV. To describe the patterns of relapse after ABVE-PC* and risk-adapted radiotherapy.

OUTLINE: This is a multicenter study.

INDUCTION THERAPY (ABVE-PC): Patients receive doxorubicin hydrochloride IV over 1-120 minutes and cyclophosphamide IV over 30-60 minutes on days 1 and 2, bleomycin sulfate IV over at least 10 minutes or subcutaneously (SC) and vincristine sulfate IV on days 1 and 8, etoposide phosphate IV over 1-2 hours on days 1-3, oral prednisone twice daily on days 1-7, and filgrastim* SC or IV daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression.

NOTE: *Patients do not receive filgrastim on day 8.

Patients undergo clinical restaging and response assessment after 2 courses of induction therapy. Patients with rapid early response (RER) or slow early response (SER) proceed to consolidation therapy. Patients with progressive disease go off study.

CONSOLIDATION THERAPY: Patients are assigned to 1 of 2 consolidation therapy regimens based on response to induction therapy. Patients who develop progressive disease after induction are taken off protocol therapy.

REGIMEN I (RER): Patients receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.

REGIMEN II (SER): Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-30 minutes on days 1 and 5, and filgrastim SC or IV daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.

Patients with a continued response after completion of consolidation therapy proceed to risk-adapted radiotherapy.

RISK-ADAPTED RADIOTHERAPY: Beginning at 3 weeks after completion of consolidation chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 3 weeks (14 fractions) in the absence of unacceptable toxicity or disease progression. Patients classified as RER receive radiation therapy only to sites of bulky disease. Patients classified as SER receive radiation therapy to sites of bulky disease and areas that remain FDG-PET avid after induction therapy.

After completion of study therapy, patients are followed up periodically for 10 years.

Being tested
bleomycin sulfate, doxorubicin hydrochloride, liposomal vincristine sulfate, vinorelbine tartrate, cyclophosphamide
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bleomycin sulfateBiological

    Also called Blenoxane, BLEO, BLM

    Given IV or SC

  • doxorubicin hydrochlorideDrug

    Also called ADM, ADR, Adria, Adriamycin PFS

    Given IV

  • liposomal vincristine sulfateDrug

    Also called liposomal vincristine, Marqibo, vincristine liposomal, vincristine sulfate liposome injection

    Given IV

  • vinorelbine tartrateDrug

    Also called Eunades, navelbine ditartrate, NVB, VNB

    Given IV

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • etoposide phosphateDrug

    Also called ETOP, Etopophos

    Given IV

  • prednisoneDrug

    Also called DeCortin, Deltra

    Given IV

  • filgrastimBiological

    Also called G-CSF, Neupogen

    Given IV or SC

  • ifosfamideDrug

    Also called Cyfos, Holoxan, IFF, IFX

    Given IV

Study groups in NCT01026220
Study groupRoleWhat they receive
Regimen I (consolidation therapy)ExperimentalPatients receive 2 more courses of ABVE-PC comprising doxorubicin hydrochloride IV over 1-120 minutes and cyclophosphamide IV over 30-60 minutes on days 1 and 2; bleomycin sulfate IV over at least 10 minutes or subcutaneously (SC) and vincristine sulfate IV on days 1 and 8; etoposide IV over 1-2 hours on days 1-3; oral prednisone twice daily on days 1-7; and filgrastim SC or IV daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression.
Receives: Biological: bleomycin sulfate; Drug: doxorubicin hydrochloride; Drug: liposomal vincristine sulfate; Drug: cyclophosphamide; Drug: etoposide phosphate; Drug: prednisone; Biological: filgrastim
Regimen II (consolidation therapy)ExperimentalPatients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, and filgrastim SC or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
Receives: Biological: bleomycin sulfate; Drug: doxorubicin hydrochloride; Drug: liposomal vincristine sulfate; Drug: vinorelbine tartrate; Drug: cyclophosphamide; Drug: etoposide phosphate; Drug: prednisone; Biological: filgrastim; Drug: ifosfamide
Induction: all patientExperimentalAll patients receive ABVE-PC induction therapy then they are assigned to Group 2 (RER), Group 3 (SER) or taken off study if they develop progressive disease.
Receives: Drug: doxorubicin hydrochloride; Drug: liposomal vincristine sulfate; Drug: cyclophosphamide; Drug: etoposide phosphate; Drug: prednisone; Biological: filgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Second-event-free Survival

    Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.

    Measured: At 4 years from enrollment

  2. Safety Analysis and Monitoring of Toxic Death

    The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.

    Measured: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).

Secondary outcomes (6)

  1. Event Free Survival

    Survival from enrollment to first event: relapse/progression, second malignancy, or death.

    Measured: At 3 years from enrollment

  2. Second-event-free Survival

    Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.

    Measured: At 4 years from enrollment

  3. Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative

    To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.

    Measured: 3 years from enrollment

  4. Relapse-free Survival

    A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy.

    Measured: 3 years from enrollment

  5. Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy

    The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy.

    Measured: During and after completion of study treatment.

  6. Overall Survival

    Survival from enrollment to death.

    Measured: At 3 years from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2009 (estimated)
  2. Study start7 Dec 2009
  3. Primary completion1 Mar 2012
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01026220
Sponsor's protocol ID
AHOD0831
Other IDs
NCI-2011-01994, CDR0000660550, AHOD0831, AHOD0831, U10CA098543
Status last verified
Dec 2021
First submitted
3 Dec 2009
Last updated
28 Apr 2022
Data monitoring committee
Yes

Publications

  • Tie X, Shin M, Lee C, Perlman SB, Huemann Z, Weisman AJ, Castellino SM, Kelly KM, McCarten KM, Alazraki AL, Hu J, Cho SY, Bradshaw TJ. Automatic Quantification of Serial PET/CT Images for Pediatric Hodgkin Lymphoma Using a Longitudinally Aware Segmentation Network. Radiol Artif Intell. 2025 May;7(3):e240229. doi: 10.1148/ryai.240229.

    PubMed 39969278

  • 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.

    PubMed 37505794

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bleomycin sulfate, doxorubicin hydrochloride and liposomal vincristine sulfate in people with Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma and Stage III Childhood Hodgkin Lymphoma, run by Children's Oncology Group at 177 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, Canada, Australia, Israel, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Second-event-free Survival (time frame: At 4 years from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01026220, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.

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