BV After Allogeneic Hematopoietic Stem Cell Transplantation (BV-ALLO)

This is an interventional treatment trial for Hodgkin Lymphoma Read More

Inclusion Criteria:

1. Male or female patients aged less than 18 or more than 65 years
2. Patients who received allo-SCT for relapse after autologous transplantation for Hodgkin's lymphoma
3. Patients who received tandem autologous and allogeneic stem cell transplantation for HL are eligible
4. Histologically confirmed CD30+ classical Hodgkin lymphoma according to local pathologist (excluding nodular lymphocyte predominant subtype)
5. Patients with Ann Arbor stage II-III or IV or extranodal localization at relapse post ASCT
6. Patients who previously received Bv may be included if the duration of response to initial Bv treatment is more than 3 months
7. Patients who previously received anti-PD1 drugs can be included
8. Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
9. Patients must be covered by a social security system
10. Female patients 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
11. 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.
12. Performance status less or equal to 2

Exclusion Criteria:

1. Patients with histologically confirmed nodular lymphocyte predominant subtype
2. Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
3. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
4. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
5. Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan).
6. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
7. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2

8. Known history of any of the following cardiovascular conditions

   Myocardial infarction within 2 years of enrollment :

   • 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 less than 50%
9. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
10. 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
11. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of Bv.
12. Known human immunodeficiency virus (HIV) positive
13. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
14. 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 non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
15. Patient who presented intolerance to Bv
16. Patient enrolled in other clinical research