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

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ClinicalTrials.gov Identifier: NCT03474133
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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.

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: Brentuximab Vedotin Phase 2

Detailed Description:
Brentuximab vedotin (BV) can induce durable response or cure in some patients with relapsed or refractory Hodgkin's lymphoma (RR HL) after autologous stem cell transplantation (ASCT) failure. It is expecting that BV alone administered earlier (after first treatment failure, without any additional treatment) can cure some RR HL patients and spare them from ASCT-associated risks and toxicity. Therefore in this study full course of BV which confirmed its curative potential in post-ASCT setting will be applicated to the potentially transplant-eligible RR HL patients immediately after first treatment failure, with a aim to assess curative potential of BV in this setting.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brentuximab Vedotin as Alternative to the Autologous Stem Cell Transplantation in Relapsed and Refractory Classical Hodgkin's Lymphoma (BASALT)
Estimated Study Start Date : April 22, 2019
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 2, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brentuximab
Brentuximab vedotin 1,8 mg/kg, every 21 days, up to 16 cycles
Drug: Brentuximab Vedotin
brentuximab vedotin 1,8 mg/kg, intravenous infusion every 21 days, up to 16 infusions per patient during study period
Other Name: Adcetris




Primary Outcome Measures :
  1. Continuous complete response (CCR) rate [ Time Frame: 3 years ]
    Rate of complete responses lasting without further treatment at least 3 years after initiation of BV therapy


Secondary Outcome Measures :
  1. Additional therapy-free survival (ATFS) [ Time Frame: 3 years ]
    time from the first dose of study medication to one of the following events: unsatisfactory investigational treatment effect (as defined as Deauville score >3 on first positron emission computed tomography/ computer tomography (PET/CT) and >2 on second), progression or relapse, death of any cause or initiation of any additional anti-lymphoma therapy (except consolidation radiotherapy) without confirmed unsatisfactory investigational treatment effect, progression or relapse

  2. Overall survival [ Time Frame: 3 year ]
    time from the first dose of BV to the death of any cause

  3. Incidence AE according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [Safety] [ Time Frame: 1 year ]
    incidence AE according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients 18 years or older
  2. 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.
  3. 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.
  4. 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.
  5. 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)
  6. PET-positive measurable disease (at least one lesion with Deauville score of >3 and at >1.5 cm on CT scan)
  7. Performance status Eastern Cooperative Oncology Group (ECOG) <3
  8. Patients potentially eligible for subsequent ASCT according treating physician decision
  9. 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.

Exclusion Criteria:

  1. More than one line of chemotherapy due to Classical Hodgkin's lymphoma (any salvage treatment)
  2. Previous treatment with brentuximab vedotin
  3. Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period
  4. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
  5. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
  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 (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%
  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 received 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 brentuximab vedotin.
  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. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474133


Contacts
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Contact: Nikolay Zhukov, MD, PhD +7(926)4177766 1cancerdoctor1@gmail.com

Locations
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Russian Federation
City clinical hospital №40 Recruiting
Moscow, Russian Federation, 129301
Contact: Vadim Doronin, MD, PhD    +74956832613    vadim.doronin@medinnova.org   
R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov State Medical University of Saint-Petersburg Recruiting
Saint Petersburg, Russian Federation, 197022
Contact: Natalia Mikhailova, MD, PhD       bmt.lymphoma@gmail.com   
Sponsors and Collaborators
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Investigators
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Principal Investigator: Nikolay Zhukov, MD, Phd Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology

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Responsible Party: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
ClinicalTrials.gov Identifier: NCT03474133     History of Changes
Other Study ID Numbers: Basalt001
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Federal Research Institute of Pediatric Hematology, Oncology and Immunology:
Hodgkin's lymphoma
Hodgkin lymphoma
relapsed
refractory
brentuximab vedotin
autologous stem cell transplantation

Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs