A Phase Ib/II Trial of Combined SGN-35 (BrentuximabVedotin) Therapy with cyclophosphamide, procarbazine, prednisone, etoposide and mitoxantrone (BrEPEM) for Older Patients with Untreated Hodgkin Lymphoma (HL)

Phase 1

• Conditions: Older Patients with Untreated Hodgkin Lymphoma; MedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-003689-28-ES
• Lead Sponsor: GELTAMO (Grupo Español de Linfomas y trasplante autólogo de médula osea)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-26
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Males or females of 60 years of age or older.
2.Previously untreated classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte depleted, lymphocyte-rich, and not otherwise specified [NOS]).
3.Stage IIB, III, and IV disease by Ann Arbor classification.
4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
5.Patients must have bi-dimensional measurable disease documented in the lymphoma baseline tumor assessment form within 30 days prior to registration (at least 1.5 cm); patients with non-measurable disease in addition to measurable disease must have been assessed within 60 days prior to registration.
6.Patients must have a bone marrow biopsy within 60 days prior to registration.
7.Patients must have a multi gated acquisition scan (MUGA) or echocardiogram within 60 days prior to study registration and the ejection fraction must be >= 50%.
8.Adequate hematologic function, defined as Absolute neutrophil count (ANC) = 1,500/mm3 / 1x109/L and Platelet count =75,000/mm3 / 75x109/L unless there is know marrow involvement of the disease
9.Serum Creatinine < 2.0 mg/dl and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
10.Total Bilirubin < 1.5 x the upper limit of normal (ULN) unless elevation is know to be due to Gilbert syndrome.
11.ALT or AST must be < 3 x the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver.
12.Hemoglobin must be = 8g/dL
13.Patients must not have received prior chemotherapy or radiation therapy for the treatment of Hodgkin lymphoma.
14.Female patient is either post-menopausal for at least 2 years before the screening visit or surgically sterile or if of childbearing potential must agree to use two effective contraceptive methods, at the same time, from the time of signing the informed consent and for 6 months following the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
15.Male patients, even if surgically sterilized, (i.e., status post vasectomy) must agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
16.Patients must sign the informed consent form before registration. Voluntary written informed consent must be signed before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1.Nodular lymphocyte predominant Hodgkin lymphoma
2.Previous treatment with BV or any other prior anti-CD30-based antibody therapy
3. Female patient who is both lactating and breast-feeding or has a positive pregnancy test during the screening period or a positive pregnancy test on Day 1 before the first dose of study drug
4.History of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: early stage [stage I or II] breast cancer treated with surgery and radiation +/- hormones [without adjuvant chemotherapy], non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou test [PAP smear])
5.Known cerebral/meningeal disease (HL or any other etiology), including signs or symptoms of PML
6.Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first dose
7.Known or suspected hepatitis B infection, or known or suspected active hepatitis C infection
Known human immunodeficiency virus (HIV) positive
8.Patients with a known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
9.Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent
10.Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
11.Any sensory or motor peripheral neuropathy greater than or equal to 2
12.Known history of any of the following cardiovascular conditions;
a.Myocardial infarction within 2 years of enrollment
b.New York Heart Association (NYHA) Class III or IV heart failure
c.Evidence of uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified