AzTrials
AzTrials

ALK+ Anaplastic Large Cell LymphomaPhase 1/2NCT02462538

Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL

A Phase 1/2 study testing Brentuximab vedotin and Imatinib in people with ALK+ Anaplastic Large Cell Lymphoma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 1 site in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is an open label pilot study of combining BV in a licensed indication with imatinib in patients with ALCL. It is intended as a "window of opportunity" trial in which the study drugs will be given as an initial substitute for conventional chemotherapy with the intention to achieve a remission enabling the patients… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ALK+ Anaplastic Large Cell Lymphoma
What is being tested?
Brentuximab vedotin and Imatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteAustria
Study dates
3 Nov 2015to 3 Nov 2021
Phase
Phase 1/2
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

  • Patients ≥ 18 years of age
  • ALK+ ALCL
  • Histologically confirmed relapse after having achieved a PR or CR with conventional therapy
  • Refractoriness to conventional chemotherapy (SD or PD after conventional chemotherapy)
  • Not able to receive conventional chemotherapy (e.g. due to comorbidities)
  • Adequate organ function, defined as the following:
Show all 15Show fewer
  • 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 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 hematologic/solid 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.
  • Written, voluntarily signed informed consent
  • Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, must practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent until 6 months after the last doses of BV and until last doses of imatinib, whatever occurs later, 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 BV, or agrees to completely abstain from heterosexual intercourse.

Who cannot join

  • Patient has received any other investigational treatment within 28 days before study entry
  • Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or imatinib
  • ECOG performance status ≥ 3
  • Acute or chronic infections
  • Female patients who are pregnant or breast-feeding
  • Known diagnosis of HIV
Show all 18Show fewer
  • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
  • 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 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 study entry
  • 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 <50%
  • Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
  • 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 nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Universitätsklinik f. Innere Medizin I, AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie

    Vienna, 1090

Other trials in Austria

About this study

Official title: A "Window of Opportunity" Trial With Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ Anaplastic Large Cell Lymphoma or Patients Ineligible for Chemotherapy

This is an open label pilot study of combining BV in a licensed indication with imatinib in patients with ALCL. It is intended as a "window of opportunity" trial in which the study drugs will be given as an initial substitute for conventional chemotherapy with the intention to achieve a remission enabling the patients to proceed to autologous or allogeneic stem cell transplantation, if eligible.

Read the detailed description

Patients will be included in this trial if they have relapsed or refractory ALK+ ALCL after at least one line of conventional chemotherapy or if they are ineligible for conventional chemotherapy.

Imatinib will be given continuously starting from day 1 of the first cycle at an oral dose of 100mg daily. The dose will be increased to 200mg daily starting from day 1 of the second cycle if no DLT occurs during the first cycle. BV will be given 3 weekly starting on day 1 at a dose of 1.8 mg/kg body weight. In the absence of a dose limiting toxicity (DLT) i.e. haematological toxicity ≥ grade 2, non- haematological toxicity ≥ grade 3, after 3 weeks of therapy, and in the presence of a clinical response (CR or PR) after cycle 1, the BV dose will continue every 3 weeks for 48 weeks. Dose modifications and stopping rules will be introduced as described in chapter 6. In case of progression at any time during the study the patient will go off trial and receive salvage treatment.

Being tested
Brentuximab vedotin, Imatinib

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 is given in a 21 day cycle intravenously starting at 1.8 mg/kg on day 1 of the first cycle and will be administered by IV infusion given over approximately 30 minutes on day 1 of each 21-day cycle.

  • ImatinibDrug

    Also called Glivec

    Imatinib will be given orally at a dose of 100mg daily starting from day 1 of the first cycle. The dose will be increased to 200mg daily starting from day 1 of the second cycle if no DLT occurs during the first cycle and will be continued at 200mg for 48 weeks.

Study groups in NCT02462538
Study groupRoleWhat they receive
Brentuximab vedotin and ImatinibExperimentalBrentuximab vedotin (every 3 weeks i.v., 1.8 mg/kg) and imatinib (200mg daily orally, escalated from 100mg daily) for up to 48 weeks
Receives: Drug: Brentuximab vedotin; Drug: Imatinib

What is being measured

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

  1. Safety of brentuximab vedotin and imatinib regime as measured by type, frequency and severity of adverse events (AEs) and their relationship to study treatment

    Measured: up to 6 years

Secondary outcomes (4)

  1. Efficacy of brentuximab vedotin and imatinib regime as measured by proportion of patients responding to treatment

    Measured: up to 6 years

  2. Ability to receive further Treatment as measured by number of patients being able to receive transplantation

    Measured: up to 6 years

  3. Progression-free survival as measured by proportion of patients displaying progressive disease

    Measured: up to 6 years

  4. Overall survival as measured by documentation of deaths

    Measured: up to 6 years

Timeline

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

  1. First posted4 Jun 2015 (estimated)
  2. Study start3 Nov 2015
  3. Primary completion3 Nov 2021
  4. Study completion3 Nov 2021

Why it stopped: Due to slow recruitment, recruitment of new patients was stopped, FU was completed for enrolled patients

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462538
Sponsor's protocol ID
AGMT_ALCL1
Status last verified
Feb 2022
First submitted
18 May 2015
Last updated
3 Mar 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Brentuximab vedotin and Imatinib in people with ALK+ Anaplastic Large Cell Lymphoma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 1 site in Austria.

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: stopped early, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was stopped early (reason given: Due to slow recruitment, recruitment of new patients was stopped, FU was completed for enrolled patients). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of brentuximab vedotin and imatinib regime as measured by type, frequency and severity of adverse events (AEs) and their relationship to study treatment (time frame: up to 6 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 NCT02462538.

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 3 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in