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

June 9, 2021 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Białystok, Poland
        • Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego
        • Contact:
          • Jarosław Piszcz, Dr heb.med.
          • Phone Number: 85 831 82 30
      • Brzozów, Poland
        • Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny
        • Contact:
      • Gdańsk, Poland
        • Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego
        • Contact:
      • Gliwice, Poland
        • Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
        • Contact:
        • Contact:
          • Martyna Palich
          • Phone Number: tel: 32 278 85 23
      • Katowice, Poland
        • Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny
        • Contact:
      • Kielce, Poland
        • Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii
        • Contact:
      • Kraków, Poland
        • Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellońskiego
        • Contact:
          • Tomasz Sacha, Prof. dr hab.n.med.
          • Phone Number: 12 424 76 32
      • Legnica, Poland
        • Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy
        • Contact:
          • Jadwiga Hołojda, Dr n. med.
          • Phone Number: 505 149 579
      • Lublin, Poland
        • Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie
        • Contact:
      • Olsztyn, Poland
        • Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
        • Contact:
      • Poznań, Poland
        • Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu
        • Contact:
      • Rzeszów, Poland
        • Klinika Hematologii, Kliniczny Szpital Wojewódzki nr 1
        • Contact:
      • Szczecin, Poland
        • Klinika Hematologii Pomorskiego Uniwersytetu Medycznego
        • Contact:
      • Toruń, Poland
        • Oddział Hematologii, Specjalistyczny Szpital Miejski
        • Contact:
      • Warszawa, Poland
        • Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny
        • Contact:
      • Warszawa, Poland
        • Klinika Hematologii, Instytut Hematologii i Transfuzjologii
        • Contact:
          • Ewa Lech - Marańda, Prof. dr hab. n. med.
          • Phone Number: 22 349 63 34
          • Email: hemsek@ihit.waw.pl
      • Warszawa, Poland
        • Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego
        • Contact:
          • Grzegorz Basak, Prof. dr hab. n. med.
          • Phone Number: 22 599 28 18
          • Email: kho@spcsk.pl
      • Wrocław, Poland
        • Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
        • Contact:
      • Wrocław, Poland
        • Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obinutuzumab
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.
Drug: Obinutuzumab
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).
Active Comparator: Rituximab
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.
Drug: Rituximab
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.)
Other Names:
  • Activ comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
assessed between days 33-34 since start of Induction I

Secondary Outcome Measures

Outcome Measure
Time Frame
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
assessed between days 20-28 since start of last course of consolidation
complete remission rate after Induction I
Time Frame: assessed between days 33-34 since start of Induction I
assessed between days 33-34 since start of Induction I
Overall complete remission
Time Frame: in 24month follow up
in 24month follow up
Probability of overall survival
Time Frame: in 24 month follow up
in 24 month follow up
Probability of relapse-free survival
Time Frame: in 24 month follow up
in 24 month follow up
Probability of event-free survival
Time Frame: in 24 month follow up
in 24 month follow up
Cumulative incidence of relapse
Time Frame: in 24 month follow up
in 24 month follow up
Rate of adverse events
Time Frame: in 24 month follow up
in 24 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

KCRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 30, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-NIO-0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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