Brentuximab Vedotin as Alternative to the Autologous Stem Cell Transplantation in Relapsed and Refractory Classical Hodgkin's Lymphoma (BASALT)

NCT03474133 | Unknown Phase 2

• 1 other identifier: Basalt001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluate possibility of brentuximab vedotin, administered after first treatment failure (no response or relapse after I line therapy) of Hodgkin's lymphoma, to induce durable response or cure without autologous stem cell transplantation.

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin's lymphoma; Hodgkin lymphoma; relapsed; refractory; brentuximab vedotin; autologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Continuous complete response (CCR) rate

  Rate of complete responses lasting without further treatment at least 3 years after initiation of BV therapy

  3 years

Secondary Outcomes (3)

• Additional therapy-free survival (ATFS)

  3 years

• Overall survival

  3 year

• Incidence AE according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [Safety]

  1 year

Study Arms (1)

Brentuximab

EXPERIMENTAL

Brentuximab vedotin 1,8 mg/kg, every 21 days, up to 16 cycles

Drug: Brentuximab Vedotin

Interventions

Brentuximab Vedotin DRUG

brentuximab vedotin 1,8 mg/kg, intravenous infusion every 21 days, up to 16 infusions per patient during study period

Also known as: Adcetris

Brentuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 years or older
• 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• 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.
• 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.
• Patients must have a diagnosis of a morphologically confirmed cluster of differentiation antigen 30 {CD30)-positive classical Hodgkin's lymphoma with primary refractory course or relapse after adequate first-line chemotherapy (with morphologically confirmation of vital tumor)
• PET-positive measurable disease (at least one lesion with Deauville score of \>3 and at \>1.5 cm on CT scan)
• Performance status Eastern Cooperative Oncology Group (ECOG) \<3
• Patients potentially eligible for subsequent ASCT according treating physician decision
• Clinical laboratory values as specified below within 7 days before the first dose of study drug:
• Absolute neutrophil count ≥ 1,500/µL unless there is known hematologic/solid tumor marrow involvement
• Platelet count ≥ 75,000/ µL unless there is known marrow involvement of the disease
• Total bilirubin must be \< 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome.
• ALT or aspartate aminotransferase (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 HL tumor in liver.
• Serum creatinine must be \< 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \> 40 mL/minute.
• Hemoglobin must be ≥ 8g/dL.

You may not qualify if:

• More than one line of chemotherapy due to Classical Hodgkin's lymphoma (any salvage treatment)
• Previous treatment with brentuximab vedotin
• Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period
• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
• Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
• Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
• Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
• 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 (see appendix #1)
• 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%
• Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
• Patients that have received other investigational agents within at least 5 half-lives of last dose of that prior treatment
• Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead

Study Sites (2)

City clinical hospital №40

Moscow, 129301, Russia

RECRUITING

R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov State Medical University of Saint-Petersburg

Saint Petersburg, 197022, Russia

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Recurrence

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Nikolay Zhukov, MD, Phd

  Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolay Zhukov, MD, PhD

CONTACT

+7(926)4177766; 1cancerdoctor1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 22, 2018
• Study Start: May 14, 2019
• Primary Completion: October 1, 2023
• Study Completion: December 2, 2023
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

RU (2)