N/A N=41 Treatment

Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma

Hodgkin Lymphoma, Adult

Bottom Line

View on ClinicalTrials.gov: NCT01578967 ↗

Enrolled (actual)

Serious AEs

14.6%

Results posted

Oct 2017

Primary outcome: Primary: Percentage of Patients With Positron Emission Tomography (PET) Negative Disease — 37 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Brentuximab vedotin (Drug); ABVD (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: UNC Lineberger Comprehensive Cancer Center
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Positron Emission Tomography (PET) Negative Disease	37	—
SECONDARY Number of Participant Who Achieved a Complete Response	37	—
SECONDARY Conversion Rate to Complete Response. Number of Participants Who Had a Partial Response Post ABVD Who Converted to a Complete Response.	3	—
SECONDARY 3 Year Progression Free Survival Rate	92	—
SECONDARY 3 Year Time to Progression Rate	92	—
SECONDARY Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher	3; 0; 0; 1; 0; 1	—

Summary

The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4 chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive radiation therapy. The use of chemotherapy and radiation may cause long term treatment related side effects such as heart problems and other cancers. Researchers are trying to find if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy cycles given is just as effective as the standard Hodgkin treatment. Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational. Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it. Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target called cluster of differentiation antigen 30 (CD30). CD30 is an important molecule on some cancer cells and some normal cells of the immune system. The purpose of this research study is to see the effects of treatment with fewer cycles of the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on study participants and Hodgkins lymphoma.

Eligibility Criteria

Inclusion Criteria

Previously untreated stage I or II non-bulky Hodgkin lymphoma
No mediastinal mass >0.33 maximum intrathoracic diameter on chest x-ray (see Appendix B)
No adenopathy ≥7.5 cm in its largest diameter
Measurable disease as assessed by 2 dimensional measurement by CT (>2cm or 1.5 cm if 0.5 cm slices are used, as in spiral CT scan)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Age ≥18 years and ≤60 years of age
Life expectancy of at least 3 months
Adequate bone marrow function (without transfusion support within one week of screening) as demonstrated by:
Hemoglobin ≥ 8 g/dL
Absolute neutrophil count (ANC) ≥ 1, 000 cells/mm3
Platelet count ≥ 75,000/mm3
Adequate hepatic and renal function as demonstrated by:
Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
Total serum bilirubin ≤1.5 x ULN
Serum creatinine ≤ 2.0 mg/dL
Negative serum human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours of day 1 of treatment with ABVD in women of child-bearing potential
Females of childbearing potential, and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of brentuximab vedotin. Effective contraception is defined as any medically recommended method (or combination of methods) as per standard of care, including abstinence. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
Signed an institutional review board (IRB)-approved informed consent document for this protocol

Prior to Day 1 of brentuximab vedotin, patients must again meet the following inclusion criteria:

Adequate bone marrow function (without transfusion support within one week of D1 of brentuximab vedotin) as demonstrated by:
Hemoglobin ≥ 8 g/dL
Absolute neutrophil count (ANC) ≥ 1, 000 cells/mm3
Platelet count ≥ 75,000/mm3
Adequate hepatic and renal function as demonstrated by:
Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
Total serum bilirubin ≤1.5 x ULN
Serum creatinine ≤ 2.0 mg/dL
Achieved at least a partial response (PR) (and not progressed) after ABVD therapy

Exclusion Criteria

Prior therapies for treatment of HL including involved field radiation therapy or any prior treatment for any malignancy with anthracyclines.
Bulky disease (defined as a mass measuring > 7.5 cm or one-third the maximal diameter of the thoracic cavity)
Known central nervous system (CNS) involvement
Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
Known history of human immunodeficiency virus (HIV), hepatitis B and hepatitis C (testing is not necessary if patient does not have history of these diseases, and no risk factors for acquisition of these viruses)
Cardiac disease with left ventricular ejection fraction of less than 45%
Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD
Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective
Other active malignancies with the exception of:
Non-melanoma skin cancer
Cervical carcinoma in situ without evidence of disease
Prostatic intraepithelial neoplasia without evidence of prostate cancer
Pregnant or lactating women

Prior to Day 1 of brentuximab vedotin, please verify the patient does not meet the criteria below:

Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01578967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.