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Hodgkin's LymphomaPhase 2BASALTNCT03474133

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

A Phase 2 study testing Brentuximab Vedotin in people with Hodgkin's Lymphoma, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 2 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin's Lymphoma
What is being tested?
Brentuximab Vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesRussia
Study dates
14 May 2019to 2 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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)
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Known human immunodeficiency virus (HIV) positive
  • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
  • 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.

Trial locations and contacts

2 sites in 1 country.

Nikolay Zhukov, MD, PhD contact

+7(926)4177766

1cancerdoctor1@gmail.com

Russia2 sites, 2 recruiting

  • City clinical hospital №40

    Moscow, 129301

    Vadim Doronin, MD, PhD, +74956832613, vadim.doronin@medinnova.org

    Recruiting

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

    Saint Petersburg, 197022

    Natalia Mikhailova, MD, PhD, bmt.lymphoma@gmail.com

    Recruiting

Other trials in Russia

About this study

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.

Read the 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.

Being tested
Brentuximab Vedotin
Keywords
Hodgkin's lymphoma, Hodgkin lymphoma, relapsed, refractory, brentuximab vedotin, autologous stem cell transplantation
Medical subject headings
Hodgkin Disease, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab VedotinDrug

    Also called Adcetris

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

Study groups in NCT03474133
Study groupRoleWhat they receive
BrentuximabExperimentalBrentuximab vedotin 1,8 mg/kg, every 21 days, up to 16 cycles
Receives: Drug: Brentuximab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Continuous complete response (CCR) rate

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

    Measured: 3 years

Secondary outcomes (3)

  1. Additional therapy-free survival (ATFS)

    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

    Measured: 3 years

  2. Overall survival

    time from the first dose of BV to the death of any cause

    Measured: 3 year

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

    incidence AE according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2018
  2. Study start14 May 2019
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion2 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03474133
Sponsor's protocol ID
Basalt001
Acronym
BASALT
Status last verified
Jul 2020
First submitted
12 Mar 2018
Last updated
21 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab Vedotin in people with Hodgkin's Lymphoma, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nikolay Zhukov, MD, PhD (+7(926)4177766, 1cancerdoctor1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous complete response (CCR) rate (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03474133.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.

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