AzTrials
AzTrials

Diffuse Large B Cell LymphomaPhase 2PLRG8NCT01481272

Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients

A Phase 2 study testing Ofatumumab, Etoposide and Ifosfamid in people with Diffuse Large B Cell Lymphoma, run by Polish Lymphoma Research Group at 8 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

It is expected that addition of anti-CD20 antibody - ofatumumab would enhance the activity of the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim (IVAC) regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Ofatumumab, Etoposide and Ifosfamid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
8 sitesPoland
Study dates
Nov 2011to Dec 2018
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

  • Patients under consideration for participation in this study must meet all of the following inclusion criteria:
  • Histologically confirmed CD20 positive diffuse large B-cell lymphoma.
  • Progressing or relapsed following prior treatment including but not limited to rituximab-CHOP chemotherapy regimen.
  • Not suitable for ASCT (age > 60 years, PS ≥ 2, prior ASCT as a part of the previous treatment for DLBCL, and/or other medical conditions that unable the patients to undergo the ASCT, e.g. NYHA II, creatinine clearance < 50 mL/min).
  • Age ≥ 18 years.
  • ECOG/ WHO performance status grades 0 - 3.
  • Resolution of toxicities from previous therapy to grade ≤ 1.
  • Written signed and dated informed consent prior to any study procedures being performed.

Who cannot join

  • Known or suspected hypersensitivity to study treatments.
  • Prior treatment with anti-CD20 monoclonal antibodies with the exception of rituximab.
  • Screening laboratory values:
  • platelets < 75 x 109/L (unless due to DLBCL involvement of the bone marrow),
  • neutrophils < 1.5 x 109/L (unless due to DLBCL involvement of the bone marrow),
  • creatinine > 2.0 times upper normal limit (unless normal creatinine clearance),
Show all 23Show fewer
  • total bilirubin >1.5 times upper normal limit (unless due to DLBCL involvement of liver or a known history of Gilbert's disease),
  • ALT > 2.5 times upper normal limit (unless due to DLBCL involvement of liver),
  • alkaline phosphatase > 2.5 times upper normal limit (unless due to DLBCL involvement of the liver or bone marrow).
  • Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrolment, whichever is longer, or currently participating in any other interventional clinical study.
  • Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
  • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
  • History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequel.
  • Known HIV positive.
  • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
  • Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.
  • Positive serology for Hepatitis B (HB).
  • Positive serology for hepatitis C (HC).
  • Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening.
  • Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy.
  • Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
  • Patients unwilling or unable to comply with the protocol.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Poland8 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. ks. Bronisława Markiewicza

    Brzozów, Podkarpackie Voivodeship, 16-200

  • Uniwersyteckie Cenrum Medyczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Szpital Morski im. PCK Oddz. Onkologii i Radioterapii

    Gdynia, Pomeranian Voivodeship, 81-519

  • Klinika Transplantacji Szpiku i Onkohematologii; Centrum Onkologii Instytut im. M.Sklodowskiej-Curie, Oddz. w Gliwicach

    Gliwice, Silesian Voivodeship, 44-101

  • Oddz. Hematologii, Samodzielny Publiczny ZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, Warmian-Masurian Voivodeship, 10-228

  • Instytut Hematologii i Transfuzjologii

    Warsaw, Masovian Voivodeship, 02-776

  • Centrum Onkologii - Istytut im. M.Sklodowskiej-Curie

    Warsaw, Masovian Voivodeship, 02-781

  • Dolnośląskie Centrum Transplantacji Komórkowych

    Wroclaw, Lower Silesian Voivodeship, 53-439

Other trials in Poland

About this study

Official title: A Phase II Trial on Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients Progressing or Relapsed After Prior R-CHOP Treatment Not Suitable for Autologous Stem Cell Transplant

It is expected that addition of anti-CD20 antibody - ofatumumab would enhance the activity of the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim (IVAC) regimen. This study is planned to determine the efficacy and safety of ofatumumab in combination with IVAC chemotherapy in patients with CD20 positive diffuse large B cell lymphoma progressing or relapsed after prior R-CHOP chemotherapy not suitable for Autologous Stem Cell Transplant (ASCT).

Read the detailed description

The purpose of this study is to assess the Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR) in adult Diffuse Large B Cell Lymphoma (DLBCL) patients progressing or relapsed after prior R-CHOP treatment not suitable for ASCT treated with O-IVAC salvage chemotherapy regimen. The secondary objective is the evaluation of progression-free survival (PFS), event-free survival (EFS), overall survival (OS), safety and tolerability.

Being tested
Ofatumumab, Etoposide, Ifosfamid, Mesna, Cytarabine
Keywords
Salvage therapy in DLBCL
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • OfatumumabDrug

    Also called Arzerra

    1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles

  • EtoposideDrug

    Also called VePesid

    60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles

  • IfosfamidDrug

    Also called Ifex

    1500mg/m2 or 1000mg/m2 (patients >/=60 years), IV, daily over 1 hour, on 1-5 days of each 21-day cycle, maximum 6 cycles

  • MesnaDrug

    Also called Mesnex

    300mg/m2 or 200mg/m2 (patients >/=60 years), IV, over 1 hour, mixed with ifosfamid then 900mg/m2 or 600mg/m2 (patients >/=60 years)over 12 hour or by local practice, on 1-5 days of each 21 day cycle, maximum 6 cycles

  • CytarabineDrug

    Also called Cytosar

    2g/m2 or 0,5-1g/m2 (patients >/= 60 years), IV, over 3 hours, 12 hourly (total of 4 doses), on days 1-2 of each 21 day cycle, maximum 6 cycles

  • MethotrexateDrug

    Also called Methotrexat Ebeve

    12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles

  • LeukovorinDrug

    Also called Folinic Acid

    15mg, po 24 hours after methotrexate it

  • Granulocyte-Colony Stimulating FactorDrug

    Also called Filgrastim

    5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC>1.0x109/l

Study groups in NCT01481272
Study groupRoleWhat they receive
O-IVACExperimentalOfatumumab Etoposide Ifosfamide Mesna Cytarabine Methotrexate Leukovorin Granulocyte-Colony Stimulating Factor
Receives: Drug: Ofatumumab; Drug: Etoposide; Drug: Ifosfamid; Drug: Mesna; Drug: Cytarabine; Drug: Methotrexate; Drug: Leukovorin; Drug: Granulocyte-Colony Stimulating Factor

What is being measured

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

  1. Response rate

    Complete response + partial response

    Measured: 12 months post-therapy

Secondary outcomes (4)

  1. Progression-free survival

    Staying free of disease progression

    Measured: 12 month post-therapy

  2. Event-free survival

    Staying free of event such as disease progression, relapse, death, starting new anticancer therapy, patient's refusal to continue study treatment, Serious Adverse Event that causes discontinuation of study treatment

    Measured: 12 month post-therapy

  3. Overall survival

    Time since entering the study till death of any reason

    Measured: 12 months post-therapy

  4. Number of participants with adverse events as a measure of safety and tolerability

    Reporting Adverse Events and Serious Adverse Events

    Measured: 12 months post-therapy

Timeline

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

  1. First posted29 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJul 2017
  4. Study completionDec 2018

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
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01481272
Sponsor's protocol ID
PLRG8 (OMB114361)
Other IDs
2010-023568-42
Acronym
PLRG8
Status last verified
Dec 2021
First submitted
14 Nov 2011
Last updated
27 Dec 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ofatumumab, Etoposide and Ifosfamid in people with Diffuse Large B Cell Lymphoma, run by Polish Lymphoma Research Group at 8 sites in Poland.

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 8 inclusion and 23 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: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Poland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Response rate (time frame: 12 months post-therapy). 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 NCT01481272.

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 27 Dec 2021.

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