Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma

NCT01118026 | Completed Phase 2 Results

• 3 other identifiers: CALGB-50801CDR0000669076NCI-2011-02034
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 55

Brief Summary

This research is being done in order to improve treatment outcomes in patients diagnosed with bulky, early stage Hodgkin lymphoma and to reduce the side effects that are associated with use of radiation used in current treatments. The chemotherapy treatment in this study consists of a combination of four drugs approved by the Food and Drug Administration (FDA): doxorubicin, bleomycin, vinblastine, and dacarbazine. This regimen (called ABVD) has been found to be effective in treating patients with Hodgkin lymphoma and is considered the standard of treatment used with radiation therapy in patients with bulky early stage Hodgkin lymphoma. As part of the evaluation of the effectiveness of the chemotherapy treatment, PET scans will be obtained during the course of therapy. The usefulness of this PET scan will be evaluated to determine whether radiation may be left out in the treatment of disease if the PET scan shows that the patient has responded to chemotherapy alone. The plan is to identify a group of patients using early PET scans in order to change to a chemotherapy treatment called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone). It is one of the most highly effective chemotherapy regimens for Hodgkin lymphoma, but is associated with more side effects than ABVD. Although it has become standard of care in Europe, its use has been more limited in the U.S. because of concerns about toxicity.

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; adult favorable prognosis Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult lymphocyte predominant Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; adult unfavorable prognosis Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival at 36 Months

  Progression-free survival (PFS) is defined as the time from first PET/CT scan to disease progression or death. Patients who are alive without disease progression will be censored at the time of their most recent disease evaluation. The Kaplan-Meier three-year (36 month) survival estimates and confidence intervals are presented below.

  Up to 36 months

Secondary Outcomes (1)

• Complete Response

  Up to 8 weeks

Other Outcomes (4)

• Comparison of Qualitative and Semiquantitative Fludeoxyglucose-PET Findings/Changes, 2-D and Volumetric CT Changes, and Combinatorial Analyses (PET + Dedicated CT Data) With Molecular Parameters and Conventional Parameters

  Up to 3 years

• Volumetric vs 2-dimensional (2-D) Measurement Changes for Target Lesions Between Baseline and After Course 2, at the End of Chemotherapy, and After IFRT

  Up to 3 years

• Determination of the Optimal Cutoff for Absolute Decrease in Maximum SUV Body Weight (SUVbw) and SUV Lean Body Mass (SUVlbm), Relative Uptake in Tumor vs Various Reference Anatomic Sites, IHP Criteria as Well as Various Cutoffs for Post-therapy Maxim ...

  Up to 3 years

Study Arms (1)

ABVD +/- BEACOPP + radiation

EXPERIMENTAL

Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. Patients undergo a PET scan following two cycles of ABVD. If the PET scan is negative, then the patient will receive four more cycles of ABVD (a total of 6 cycles of ABVD). If the PET scan is positive, then the patient receives four cycles of escalated BEACOPP for 21 days (a total of 4 cycles). 3-6 weeks after BEACOPP therapy, patients receive radiation therapy for 5 days per week (a total of 3.5 weeks). All patients will be followed for a maximum of ten years.

Drug: ABVD; Drug: BEACOPP; Radiation: radiation therapy

Interventions

ABVD DRUG

doxorubicin 25 mg/m\^2 IV bleomycin 10 units/m\^2 IV vinblastine 6 mg/m\^2 IV dacarbazine 375 mg/m\^2 IV

ABVD +/- BEACOPP + radiation

BEACOPP DRUG

bleomycin 10 units/m\^2 IV on Day 8 etoposide 200 mg/m\^2 IV on Days 1, 2 and 3 doxorubicin 35 mg/m\^2 IV on Day 1 cyclophosphamide 1250 mg/m\^2 IV on Day 1 vincristine 1.4 mg/m\^2 IV on Day 8 procarbazine 100 mg/m\^2 orally on Days 1-7 prednisone 40 mg/m\^2 orally on Days 1-14

ABVD +/- BEACOPP + radiation

radiation therapy RADIATION

ABVD +/- BEACOPP + radiation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

1. Documentation of Disease: * Histologically documented Hodgkin lymphoma subclassified according to the WHO modification of the Rye Classification and staged according to the modified Ann Arbor Staging Classification system. * Patients must have clinical stage IA, IB, IIA or IIB. * Patients with "E" extensions will be eligible if all other criteria have been met. * Nodular lymphocyte predominant Hodgkin lymphoma is excluded. * Core needle biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. Fine needle aspirates are not acceptable. If multiple specimens are available, please submit the most recent. Failure to submit pathology materials within 60 days of patient registration will be considered a major protocol violation. * Patients must have a mediastinal mass \> 0.33 maximum intrathoracic diameter on standing postero-anterior chest x-ray or mass measuring \> 10 cm in its largest diameter. 2. Second Malignancy: No "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse. 3. Prior Therapy - Patients may have had one cycle only of ABVD prior to enrolling on study. No other prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma is allowed. If patient has had one cycle of ABVD, in order to be eligible to enroll on CALGB 50801, the patient must have had all of the following tests prior to starting the first cycle of ABVD: * LVEF by ECHO or MUGA * PFTs (including DLCO/FVC)CT scan (neck\*, chest, abdomen, pelvis) * FDG-PET/CT scan * Chest X-ray, PA \& Lateral * CBC, differential, platelets * ESR * Serum creatinine * Glucose * AST * Alkaline phosphatase * Bilirubin * LDH Patients with a negative FDG-PET/CT scan do not need to have had a dedicated neck CT scan prior to starting the previous cycle of ABVD. 4. ECOG Performance status 0-2. 5. LVEF and DLCO - LVEF by ECHO or MUGA within institutional normal limits unless thought to be disease related. DLCO ≥ 60% with no symptomatic pulmonary disease unless thought to be disease related. 6. HIV Infection - Patients with known HIV must have a CD4 count \> 350 and be on concurrent antiretrovirals. Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk. 7. Pregnancy Restrictions - Non-pregnant and non-nursing. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control. 8. Age Restricitions - Age 18 - 60 years 9. Initial Required Laboratory Data: * ANC ≥ 1000/μL * Platelet count ≥ 100,000/μL * Serum Creatinine ≤ 2 mg/dL * Bilirubin\* ≤ 2 x upper limit of normal * AST ≤ 2 x upper limit of normal\* - In the absence of Gilbert's disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (55)

Naval Medical Center -San Diego

San Diego, California, 92134, United States

Location

Saint Helena Hospital

St. Helena, California, 94574, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, 46545, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Norris Cotton Cancer Center-Nashua

Nashua, New Hampshire, 03063, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Carolinas HealthCare System NorthEast

Concord, North Carolina, 28025, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, 43537, United States

Location

Saint Charles Hospital

Oregon, Ohio, 43616, United States

Location

Flower Hospital

Sylvania, Ohio, 43560, United States

Location

Mercy Saint Anne Hospital

Toledo, Ohio, 43623, United States

Location

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, 43623, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Saint Francis Hospital

Greenville, South Carolina, 29601, United States

Location

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, 05602, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (2)

• 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 DERIVED

• LaCasce AS, Dockter T, Ruppert AS, Kostakoglu L, Schoder H, Hsi E, Bogart J, Cheson B, Wagner-Johnston N, Abramson J, Blum K, Leonard JP, Bartlett NL. Positron Emission Tomography-Adapted Therapy in Bulky Stage I/II Classic Hodgkin Lymphoma: CALGB 50801 (Alliance). J Clin Oncol. 2023 Feb 10;41(5):1023-1034. doi: 10.1200/JCO.22.00947. Epub 2022 Oct 21.

  PMID: 36269899 DERIVED

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

BEACOPP protocol; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Ann S. LaCasce, MD
• Organization: Alliance for Clinical Trials in Oncology

alacasce@partners.org

617-632-5959

Study Officials

• Ann S. LaCasce, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 6, 2010
• Study Start: September 1, 2010
• Primary Completion: September 30, 2020
• Study Completion: September 29, 2021
• Last Updated: December 1, 2021
• Results First Posted: December 1, 2021

Record last verified: 2021-11

Locations

US (55)