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Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 OVERALL (PALG ALL7)

Primary Purpose

CD20-positive Acute Lymphoblastic Leukemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Obinutuzumab
Rituximab
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CD20-positive Acute Lymphoblastic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 years.
  2. Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.
  3. Signed written informed consent.
  4. Adequate contraception in case of women with child-bearing potential

Exclusion Criteria:

  1. Lymphoblastic lymphoma with bone marrow blasts<20%.
  2. Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.
  3. Major surgery within 4 weeks before enrollment.
  4. Impaired cardiac function: ejection fraction <40% on echocardiography, QTc interval > 450 ms on baseline electrocardiogram. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
  5. Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus
  6. Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
  7. Serum creatinine > 2 times the upper normal limit of the laboratory, total bilirubin> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase > 5 upper normal limit, unless related to Acute lymphoblastic leukemia
  8. Intolerance to treatment with monoclonal antibody.
  9. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.
  10. Inability to obtain written informed consent.
  11. Inability to comply with regular monitoring.

Sites / Locations

  • Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego
  • Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny
  • Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego
  • Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
  • Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny
  • Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii
  • Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellońskiego
  • Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy
  • Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie
  • Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
  • Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu
  • Klinika Hematologii, Kliniczny Szpital Wojewódzki nr 1
  • Klinika Hematologii Pomorskiego Uniwersytetu Medycznego
  • Oddział Hematologii, Specjalistyczny Szpital Miejski
  • Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny
  • Klinika Hematologii, Instytut Hematologii i Transfuzjologii
  • Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego
  • Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
  • Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Obinutuzumab

Rituximab

Arm Description

Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.

Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.

Outcomes

Primary Outcome Measures

Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.

Secondary Outcome Measures

The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.
complete remission rate after Induction I
Overall complete remission
Probability of overall survival
Probability of relapse-free survival
Probability of event-free survival
Cumulative incidence of relapse
Rate of adverse events

Full Information

First Posted
April 25, 2021
Last Updated
June 9, 2021
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
KCRI
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1. Study Identification

Unique Protocol Identification Number
NCT04920968
Brief Title
Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 OVERALL
Acronym
PALG ALL7
Official Title
Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2021 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
KCRI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD20-positive Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obinutuzumab
Arm Type
Experimental
Arm Description
Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Description
Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Intervention Description
Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland. Patients in experimental arm will receive obinutuzumab .Obinutuzumab: 1000 mg i.v. (first infusion divided into 100 mg on d. 1 and 900 mg on d. 2).
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Activ comparator
Intervention Description
Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland.The protocol includes the use of rituximab in combination chemotherapy. Rituximab: 375 mg/m2 intravenously (i.v.)
Primary Outcome Measure Information:
Title
Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.
Time Frame
assessed between days 33-34 since start of Induction I
Secondary Outcome Measure Information:
Title
The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.
Time Frame
assessed between days 20-28 since start of last course of consolidation
Title
complete remission rate after Induction I
Time Frame
assessed between days 33-34 since start of Induction I
Title
Overall complete remission
Time Frame
in 24month follow up
Title
Probability of overall survival
Time Frame
in 24 month follow up
Title
Probability of relapse-free survival
Time Frame
in 24 month follow up
Title
Probability of event-free survival
Time Frame
in 24 month follow up
Title
Cumulative incidence of relapse
Time Frame
in 24 month follow up
Title
Rate of adverse events
Time Frame
in 24 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years. Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts. Signed written informed consent. Adequate contraception in case of women with child-bearing potential Exclusion Criteria: Lymphoblastic lymphoma with bone marrow blasts<20%. Patients with a history of chronic myeloid leukemia or other myeloproliferative disease. Major surgery within 4 weeks before enrollment. Impaired cardiac function: ejection fraction <40% on echocardiography, QTc interval > 450 ms on baseline electrocardiogram. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias). Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease. Serum creatinine > 2 times the upper normal limit of the laboratory, total bilirubin> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase > 5 upper normal limit, unless related to Acute lymphoblastic leukemia Intolerance to treatment with monoclonal antibody. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age. Inability to obtain written informed consent. Inability to comply with regular monitoring.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Giebel, prof. dr n.med.
Phone
32 278 85 23
Email
Sebastian.Giebel@io.gliwice.pl
Facility Information:
Facility Name
Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego
City
Białystok
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarosław Piszcz, Dr heb.med.
Phone
85 831 82 30
Facility Name
Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny
City
Brzozów
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacek Krzanowski, dr n.med
Phone
13 4309728
Email
hematologia-sek@szpital-brzozow.pl
Facility Name
Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego
City
Gdańsk
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Witold Prejzner, Dr n.med.
Phone
58 349 22 30
Email
wpre@gumed.edu.pl
Facility Name
Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
City
Gliwice
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Giebel, prof. n.med.
Email
Sebastian.Giebel@io.gliwice.pl
First Name & Middle Initial & Last Name & Degree
Martyna Palich
Phone
tel: 32 278 85 23
Facility Name
Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny
City
Katowice
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Helbig, Prof. dr hab. n. med
Phone
32 2591 281
Email
ohits@spskm.katowice.pl
Facility Name
Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii
City
Kielce
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Sierlecka, lek.med.
Phone
41 367 4841
Email
hematologia@onkol.kielce.pl
Facility Name
Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellońskiego
City
Kraków
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Sacha, Prof. dr hab.n.med.
Phone
12 424 76 32
Facility Name
Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy
City
Legnica
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jadwiga Hołojda, Dr n. med.
Phone
505 149 579
Facility Name
Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie
City
Lublin
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Hus, Prof.dr hab.n.med.
Phone
81 53 45 468
Email
marekhus@umlub.pl
Facility Name
Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
City
Olsztyn
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janusz Hałka, dr n.med.
Phone
89 539 81 30
Email
ord.hematologia@poliklinika.net
Facility Name
Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu
City
Poznań
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lidia Gil, Prof. dr hab. n. med.
Phone
61 854 93 83
Email
hematologia.sekretariat@skpp.edu.pl
Facility Name
Klinika Hematologii, Kliniczny Szpital Wojewódzki nr 1
City
Rzeszów
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirosław Markiewicz, Prof.dr hab.n.med
Phone
17 86 66 609
Email
m.markiewicz@szpital.rzeszow.pl
Facility Name
Klinika Hematologii Pomorskiego Uniwersytetu Medycznego
City
Szczecin
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Zdziarska, Prof.dr hab.n.med.
Phone
091 4253347
Email
sekr.hemat@spsk1.szn.pl
Facility Name
Oddział Hematologii, Specjalistyczny Szpital Miejski
City
Toruń
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edyta Cichocka, Dr n.med.
Phone
56 61 00 411
Email
hematologia@med.torun.pl
Facility Name
Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny
City
Warszawa
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Rzepecki, Prof. dr hab. n. med.
Phone
22 261 817 160
Email
przepecki@wim.mil.pl
Facility Name
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
City
Warszawa
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Lech - Marańda, Prof. dr hab. n. med.
Phone
22 349 63 34
Email
hemsek@ihit.waw.pl
Facility Name
Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego
City
Warszawa
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Basak, Prof. dr hab. n. med.
Phone
22 599 28 18
Email
kho@spcsk.pl
Facility Name
Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
City
Wrocław
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Czyż, Dr n.med.
Phone
71 784 25 76
Email
khn@usk.wroc.pl
Facility Name
Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku
City
Wrocław
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarosław Dybko, dr n.med.
Phone
71 78 313 75
Email
jdybko@dctk.wroc.pl

12. IPD Sharing Statement

Learn more about this trial

Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 OVERALL

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