Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Brentuximab vedotin (BV) will be prescribed to patients in accordance with indication for treatment as second or subsequent line therapy after failure of at least one type of first-line therapy for patients with relapsed or refractory HL who are not candidates for ASCT, or for patients with relapse after ASCT within routine hematological practice. Dose, preparation, administration etc - as in Instruction for use (Prescribing information).

Tatiana Nikitina, PhD

Natalia Fadeeva, MD, PhD

Maria Andrievskih, MD

Gulnara Husainova, MD, PhD

Nikita Mochkin, MD, PhD

Vyacheslav Kurakin, MD

Natalia Trenina, MD

Vladimir Ivanov, MD, PhD

Kirill Lepik, MD, PhD

Tatiana Shelekhova, MD, PhD

Dmitriy Sherstnev, MD

Elena Volodicheva, MD, PhD

Mikhail Volkov, MD, PhD

Olga Larionova, MD

The goal of this is study is focusing on assessment of patient-reported outcomes in terms of quality of life (QoL) and symptom profile as well on evaluation of clinical efficacy and safety of BV in patients with refractory/resistant HL in a real-world setting.

Information on QoL in patients with refractory/relapsed HL treated with BV is quite limited till now. Moreover, PRO data in patients treated for refractory/relapsed HL with BV, including long-term effects of BV on patient's QoL in a real-world setting are lacking.

The goal of this is study is focusing on assessment of patient-reported outcomes in terms of QoL and symptom profileas well on evaluation of clinical efficacy and safety of BV in patients with refractory/resistant HL in a real-world setting.

For PROs assessment QoL and symptom data will be received from patients' reports before and at 3, 6, 9, 12 months after BV treatment start and in 3 months at follow-up (15 months after base-line). The maximum duration of PRO monitoring - 15 months. To evaluate PROs the followings tools will be used: RAND SF-36 for quality of life assessment, Edmonton Symptom Assessment System (ESAS-R) for symptom assessment and Patient Global Impression of Change (PGIC) for assessment of a patient's belief about the effect of treatment.

For evaluation of response rates, duration of response, PFS and for analysis of AEs/SAEs during BV treatment the clinical data will be collected from health records at base-line, at 3, 6, 9, 12 months after BV treatment start and at 15 months of follow-up or till the last dose of BV.

No randomization and stratification will be applied. The analysis of primary (PROs assessment) and secondary outcomes (clinical outcomes) will be provided in the total patient population (n=70) and in two subgroups. The subgroups of interest will be: patients with relapsed or refractory HL who are not candidates for ASCT with prescribed treatment with BV as ≥2nd line therapy, and patients with relapse after ASCT with prescribed treatment with BV.

Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin

Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin: a Multicenter, Prospective, Observational Study in a Real World Setting

The change in QoL will be assessed as the difference in QoL scales of RAND SF-36 as compared to their baseline and the difference in proportion of patients with significant negative impact on QoL. The change in symptom severity will be assessed as the difference in the severity of each ESAS-R scale and the symptom distress score as compared with their baseline value. The proportion of patients with ≥1 point improvement on ESAS-R scale will be analyzed as well.

Tumor response will be assessed and derived using the RESIST criteria v. 1.0.

PFS will be estimated from initiation of treatment with BV till the disease progression or death from any cause.

The analysis of safety of BV will include reporting adverse events (AEs)/serious AEs (SAEs). For adverse events assessment the NCI CTCAE v. 4.0 will be used. The incidence and severity of any AEs/SAEs will be evaluated within the study

Multinational Center for Quality of Life Research, Russia

Mocetinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

MGCD0103 administered orally three times per wek

MGCD0103

Gregory Reid, MSc, MBA

MGCD0103 is an experimental drug that belongs to a class of drugs known as the histone deacetylase inhibitors, which may restore normal control in cancer cells by affecting the genes and proteins that are being made. Laboratory tests show that this new investigational anti-cancer drug can slow down the growth of human cancer cells in mice; two clinical research studies are currently being performed in humans with cancer and a similar study is being performed in patients with the same disease.

The purpose of this study is to find out what effect the experimental drug MGCD0103 has on patients with relapsed and refractory Hodgkin's lymphoma.

Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

A Phase II Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Mirati Therapeutics Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin	NCT03440788	Relapsed or Ref...	Brentuximab Ved...	18 Years -	Multinational Center for Quality of Life Research, Russia
Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma	NCT00358982	Hodgkin's Lymph...	MGCD0103	18 Years -	Mirati Therapeutics Inc.

Spots Global Cancer Trial Database for relapsed or refractory hodgkin's lymphoma