BRENTUXIMAB VEDOTIN as Pre-ASCT Induction Therapy in R/R HL Patients Non Responding to IGEV

NCT ID: NCT02244021

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-10-31

Brief Summary

A pilot phase II study with brentuximab vedotin as pre-ASCT induction therapy in relapsed/refractory Hodgkin's lymphoma patients non-responding to IGEV salvage treatment.

Detailed Description

Brentuximab vedotin emerged as active single-agent in the treatment of relapsed or refractory HL.

Some patients don't reach a complete response after salvage treatment with IGEV (ifosfamide, gemcitabine, vinorelbine) and remain PET positive so the idea is to treat this subset of patients with brentuximab vedotin with the aim of achieving a complete remission before transplant.

Conditions

Relapsed/Refractory Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BRENTUXIMAB VEDOTIN

1 arm for all patients

Group Type: EXPERIMENTAL

BRENTUXIMAB VEDOTIN

Intervention Type: DRUG

Patients with FDG-PET positive after IGEV will be treated with brentuximab vedotin as followed: 1.8 mg/kg every 3 weeks as a 30-minute outpatient IV infusion for a total of 4 cycles of treatment

Growth factors may be used at the discretion of investigators but are not routinely advised.

Patients with FDG-PET negative after brentuximab vedotin treatment will be addressed to high dose chemotherapy followed by ASCT.

Interventions

BRENTUXIMAB VEDOTIN

Patients with FDG-PET positive after IGEV will be treated with brentuximab vedotin as followed: 1.8 mg/kg every 3 weeks as a 30-minute outpatient IV infusion for a total of 4 cycles of treatment

Growth factors may be used at the discretion of investigators but are not routinely advised.

Patients with FDG-PET negative after brentuximab vedotin treatment will be addressed to high dose chemotherapy followed by ASCT.

Intervention Type: DRUG

Other Intervention Names

SGN-35

Eligibility Criteria

Inclusion Criteria

1. Classical Hodgkin Lymphoma according to the WHO classification

2. Histologically confirmed CD30+ HL at diagnosis

3. Patients at the first line salvage therapy

4. FDG-PET positivity after two cycles of IGEV treatment

5. PBPCs should have been collected after the first or the second IGEV cycle

6. Age≥ 18 years

7. ECOG PS of 0-2

8. Life expectancy > 6 months.

9. Written informed consent

10. Patients available for periodic blood sampling, study-related assessments and management of toxicity

11. Females of childbearing potential must have a negative β-HCG pregnancy test result (pregnancy test should be performed at screening an on day 1 of cycle 1 prior to brentuximab vedotin treatment).

12. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.

13. Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.

14. Required baseline laboratory data: Absolute neutrophil count ≥ 1500/µl, Platelet count ≥ 75.000/ µl, Haemoglobin must be ≥ 8 g/dL, Serum bilirubin ≤ 1.5 times ULN, Serum creatinine < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN

Exclusion Criteria

1. Peripheral neuropathy > Grade 1

2. Histologic diagnosis different from Hodgkin Lymphoma

3. First line treatment with BEACOPP

4. Compressive symptoms caused by the presence of Lymphoma

5. Patients treated previously with any anti-CD30 antibody.

6. Known hypersensitivity to any recombinant proteins, murine proteins, or excipients contained in the brentuximab vedotin formulation.

7. Known human immunodeficiency virus (HIV) positive

8. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection

9. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

10. Patients with known history of any of the following cardiovascular conditions:Myocardial infarction within 2 years of randomization, New York Heart Association (NYHA) Class III or IV heart failure, Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities, Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%

11. Patients with known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of brentuximab vedotin.

12. Patients with known active Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin.

13. Patients with known cerebral/meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy

14. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to protocol.

15. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.

16. Patients who are pregnant, or lactating and breastfeeding.

17. Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angelo Michele Carella, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hematology Division, IRCCS AOU San Martino, Genova, Italy

Locations

Istituto di Ematologia "L. & A. Seragnoli" , Policlinico S. Orsola Malpighi

Bologna, , Italy

Ematologia, IRCCS AOU San Martino-IST

Genova, , Italy

Ematologia Ospedale Vito Fazzi

Lecce, , Italy

Ematologia e Unità BMT IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Università degli Studi di Modena e Reggio Emilia, D.A.I di Medicina diagnostica clinica e sanità pubblica, AOU Policlinico

Modena, , Italy

Dipartimento di Oncologia Medica ed Ematologia, Istituto Humanitas

Rozzano, , Italy

SC Ematologia - Azienda Ospedaliera AO Città della Salute e della Scienza

Torino, , Italy

Countries

Italy

Other Identifiers

FIL_BRidge

Identifier Type: -

Identifier Source: org_study_id