Phase 4 Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Male or female patients 18 years or older.
A diagnosis of relapsed or refractory classical HL, confirmed by biopsy if clinically
feasible on the basis of local pathology review.
A history of at least 1 prior systemic chemotherapeutic regimen.
Not suitable for SCT or multiagent chemotherapy
Bidimensional measurable disease, of at least 1.5 cm, as documented by radiographic
technique (spiral CT scan preferred), per IWG Revised Response Criteria for
Malignant Lymphoma.
Patients must have completed any prior immunotherapy (eg, rituximab) or
radioisotopic therapy at least 12 weeks before the first dose of brentuximab vedotin
in the absence of clear disease progression.
Patient has recovered to Grade 1 or lower toxicity related to radiotherapy,
immunotherapy, and chemotherapy unless evidence of toxicity is due to underlying
HL. If toxicity is related to underlying HL, Grade 2 or lower toxicity is acceptable

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Previous treatment with brentuximab vedotin.
2. Previously received an ASCT or alloSCT.
3. Female patients who are lactating and breastfeeding or have a positive serum or urine
pregnancy test during the Screening period or a positive serum or urine pregnancy
test on Day 1 before first dose of study drug.
4. Any serious medical or psychiatric illness that could, in the investigator’s opinion,
potentially interfere with the completion of treatment according to this protocol.
5. Treatment with any investigational products within 4 weeks before the first dose of
study drug.
6. Any of the following cardiovascular conditions or values within 6 months before the
first dose of study drug:
- New York Heart Association Class III or IV heart failure (refer to
Section 15.3)
- Myocardial infarction within 6 months before the first dose of study drug
- Evidence of current uncontrolled cardiovascular conditions, including
clinically relevant cardiac arrhythmias, congestive heart failure (CHF),
angina, or electrocardiographic evidence of acute ischemia or active
conduction system abnormalities
7. 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: nonmelanoma skin
cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on
biopsy or a squamous intraepithelial lesion on PAP smear.)
8. Any active uncontrolled systemic viral, bacterial, or fungal infection.
9. Any antimicrobial, antiviral, or antifungal therapy within 1 week prior to the first
dose of brentuximab vedotin (routine prophylaxis is acceptable).
10. Known cerebral/meningeal disease, including signs or symptoms suggestive of PML,
or any history of PML.
11. Known human immunodeficiency virus (HIV).
12. Known hepatitis B surface antigen positive, or known or suspected active hepatitis C
infection.
13. Grade 2 or higher peripheral neuropathy.
Current therapy with other systemic antineoplastic or investigational agents.
15. Therapy with corticosteroids at higher than or equal to 20 mg/day of prednisone
equivalent within 1 week before administration of the first dose of brentuximab
vedotin.
16. Patients with a known hypersensitivity to recombinant proteins, murine proteins, or
any excipient contained in the drug formulation.
17. Patients with dementia or an altered mental state that would preclude the
understanding and rendering of informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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