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JOURNAL ONKOLOGIE – STUDIE

ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT

Rekrutierend

NCT-Nummer:
NCT04785547

Studienbeginn:
Dezember 2020

Letztes Update:
08.03.2021

Wirkstoff:
Blinatumomab

Indikation (Clinical Trials):
Neoplasm, Residual, Precursor Cell Lymphoblastic Leukemia-Lymphoma

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
Phase 2

Sponsor:
Prof. Christina Peters

Collaborator:
Amgen

Studienleiter

Christina Peters, MD
Study Chair
St.Anna Kinderspital, Vienna, Austria

Kontakt

Studienlocations
(3 von 15)

University Hospital Gasthuisberg (UZ Leuven)
Leuven
BelgiumNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Marleen Renard, MD
E-Mail: marleen.renard@uzleuven.be

An Michiels
E-Mail: an.michiels@uzleuven.be
» Ansprechpartner anzeigen
Nicolaus Copernicus University Collegium Medicum
Bydgoszcz
PolandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Mariusz Wysocki, MD
E-Mail: m.wysocki@cm.umk.pl

Jan Styczyński, MD
E-Mail: jstyczynski@cm.umk.pl
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

6.2.1 Screening / Pretreatment * The screening process begins on the date the subject (or

legally acceptable representative) signs the IRB/EC approved ICF and assent form and

continues until enrollment. Informed consent and assent must be obtained before completing

any study-specific procedures. After written informed consent and assent have been obtained,

subjects will be screened in order to assess eligibility for study participation. Only

eligible subjects who meet the inclusion/exclusion criteria listed in Section 4 will be

enrolled in the study. The total screening window is up to 14 days. If a subject has not met

all eligibility criteria at the end of the 14-day window, the subject will be classified as a

screen failure on the subject screening log. Subjects who screen fail may be eligible to

rescreen one time per Section 6.2.2.

The following assessments/procedures are to be completed during the screening period at time

points designated in the Schedule of Assessments (Table 3):

- Confirmation that the Informed Consent Form and Assent Form have been signed

- Product History Form for subjects who were enrolled in a previous Amgen Blincyto study

- Relevant medical history: including all data which are documented in FORUM trial

- Review of inclusion/exclusion criteria

- Physical examination

- Local laboratory assessments within 7 days prior to treatment start:

- Chemistry

- Coagulation

- Hematology (CBC with differential)

- Bone marrow aspirate (morphological and MRD assessment)

· Lumbar puncture

- Serious Adverse Event reporting 6.2.2 Rescreening Subjects who are unable to complete or

meet eligibility at the initial screening will be permitted to rescreen once, provided

study recruitment has not closed. Upon signing a new Informed Consent Form and Assent

Form, a new 14-day screening window will begin. Subjects will retain the same subject

identification number assigned at the original screening.

After reconsenting, all screening procedures, including the bone marrow aspirate, must be

repeated. However, previous bone marrow aspirate/biopsy taken within 14 days of the planned

treatment start of Blincyto can be used to determine eligibility.

6.2.3 Treatment The following procedures will be completed during day 1 to day 29 at the

times designated in the Schedule of Assessments (Table 3). For assessments performed at day

1, all study procedures should be completed prior to the initiation of Blincyto therapy,

unless noted otherwise.

- Physical examination (D1 of each treatment cycle), prior to infusion start

- Bone marrow aspirate/biopsy (morphological and MRD assessment): day 29, not mandatory in

case of documented disease progression or relapse

- Chemistry, Coagulation, Hematology (Complete blood test (CBC) with differential)

- day 1: +6h after the first dose of Blincyto

- day 2: any time

- day 3: any time

- In addition, hematology only: day 29, not mandatory in case of documented disease

progression or relapse.

- Immunoglobulins (IgG only)

- Day 1, prior to infusion start

- Day 29, after end of infusion

- Vital signs (pulse and temperature only), at the following time points:

- Day 1, prior to infusion start

- Day 15 and day 29 (any time)

- Any other time as deemed necessary by the investigator per institutional guidelines

- Neurological examination (eg, finger-nose and/or writing test, as appropriate for age):

- day 1, prior to infusion start

- day 2 and day 3, any time

- Any other time as deemed necessary by the investigator per institutional guidelines

- Serious Adverse Event reporting 6.2.4 Safety Follow-up Visit(s) / End of Study Visit

All subjects, including subjects who withdraw early, should complete a safety follow-up visit

30 days (± 4 days) after the last dose of Blincyto. The following procedures will be

completed at the visit:

- Physical examination

- Local laboratory assessments:

- Chemistry

- Coagulation

- Hematology (CBC with differential)

- Immunoglobulins (IgG only)

- Urine or serum pregnancy test (female adolescents of childbearing potential only), if

applicable

- Serious Adverse Event reporting 6.2.5 Long-term Follow-up All subjects will be followed

in the long-term follow-up portion of the study for OS.

Subjects in remission will also be followed for duration of response. Following the safety

follow-up visit, subjects will be followed every 6 months (± 2 weeks) until 14 months after

the first dose of Blincyto to assess disease status. The following procedures will be

completed for subjects who remain in remission:

- Disease/Survival status

- Bone marrow aspirate/biopsy (morphological and MRD assessment) at day +180 post HSCT and

day 360 post HSCT.

- Hematology (neutrophils and platelets) 6.2.6 Lumbar Puncture to Examine Cerebrospinal

Fluid In case of clinical signs of CNS-disease a lumbar puncture will be performed as

outlined in the Schedule of Assessments (Table 3) to assess for possible leukemic

involvement of the CNS. CSF cell count, glucose, and protein will be measured at the

local laboratory as part of the examination. Additional investigations of the CSF should

be performed as clinically appropriate.

If an Ommaya reservoir is in place and there is no evidence of blockage of CSF flow in the

spinal canal, withdrawal of a sample through the Ommaya reservoir is permitted.

6.2.7 Bone Marrow Biopsy / Aspiration

Bone marrow will be used for hematological assessment and for evaluation of MRD. The

following samples will be obtained for cytomorphological assessment and MRD measurement by a

local laboratory:

- Cytomorphology/percentage of blasts: bone marrow aspirates at screening, at the end of

each treatment cycle, and every 6 months during long-term follow-up for subjects in

remission only, until relapse.

- MRD: Aliquots at screening will be collected and analyzed. Aliquots for each subsequent

bone marrow assessment may be collected and analyzed, if applicable.

In case of insufficient quality of the bone marrow material at the end of each treatment

cycle, a repeat bone marrow assessment should be performed prior to treatment start in the

next cycle or at the safety follow-up visit if the subject has not progressed and no further

treatment cycles are to be administered.

The degree of bone marrow infiltration defined by the percentage of leukemic blasts in bone

marrow will be evaluated by local laboratories per cytomorphology and flow cytometry

immunophenotyping. During screening the B-precursor phenotype with CD19 positivity (at least

partial) should be confirmed for inclusion.

6.2.8 Laboratory Assessments The analytes for all laboratory tests used throughout this study

are listed in the table below. All screening and on-study laboratory samples will be

collected and processed at the investigator's local laboratory and analyzed locally. Standard

laboratory tests will be performed according to institutional guidelines. The date and time

of sample collection will be recorded in the source documents at the site. Blood draws should

not be done via the central venous access. Exception: If a permanent central line with more

than one lumen is used, blood draws can be done via the lumen that is not used for drug

administration. Table 4 outlines the specific analytes that will be assessed during the study

at time points outlined in the Schedule of Assessments (Table 3). Any additional follow-up

laboratory testing should be performed per standard of care for the treatment of ALL and

according to ALL SCTped 2012 FORUM-study.

*Numeration as per protocol

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients participating in ALL SCTped 2012 FORUM;

- Age: > 0.5 years and < 21 years;

- B-precursor ALL with < 5% blasts in the bone marrow (M1 bone marrow) and CD19+ minimal

residual disease (MRD) before and/or following allogeneic HSCT;

- Indication for first allogeneic HSCT was CD19+ ALL in first, second or third

remission;

- Allogeneic Hematopoietic Stem Cell Transplant (HSCT): at first dose of Blincyto

patients must be at least > 60 days post-SCT and without evidence of grade 2 or higher

acute GVHD and off systemic immunosuppression (tapering allowed) and at least 4 weeks

after last donor lymphocyte infusion (DLI);

- Performance-Status (Karnovsky/Lansky): above 50%;

- Written consent of the parents/legal guardian and, if necessary, the minor patient via

"Informed Consent Form";

- No pregnancy;

- No secondary malignancy.

Exclusion Criteria:

- Patients who do not fulfill the inclusion criteria;

- The whole protocol or essential parts are declined either by patient himself/herself

or the respective legal guardian;

- Malformation syndromes;

- Renal impairment (< 30% of normal glomerular filtration rate);

- Severe pulmonary, hepatic or cardiac impairment due to toxicity or infection (> CTCAE

grade 3);

- Recent episode of seizures or posterior reversible encephalopathy syndrome in the past

30 days;

Studien-Rationale

Primary outcome:

1. Rate of MRD-negativity (Time Frame - Patients may receive 2 cycles of treatment. A single cycle of treatment is 28 days (4 weeks) of continuous infusion. Each cycle of treatment is separated by a 14 day (2 weeks) treatment-free interval.):
Rate of MRD-negativity is defined as < 0.01 percent (%) by flow cytometry and < 10-4 by PCR after first and second Blincyto cycle

Geprüfte Regime

  • Blinatumomab (Blincyto):
    15 mcg/m2/day for 28 days

Quelle: ClinicalTrials.gov


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