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B-cell Lymphoid LeukemiaPhase 2CLL0911NCT01762202

Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia.

A Phase 2 study testing Cyclophosphamide, Fludarabine and Ofatumumab in people with B-cell Lymphoid Leukemia and Young Patients, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 22 sites in Italy.

Completed

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

Official record
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Trial summary

Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined with ofatumumab (FCO2) in previously untreated "young" patients with Chronic Lymphocytic Leukemia (CLL). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
B-cell Lymphoid Leukemia, Young Patients
What is being tested?
Cyclophosphamide, Fludarabine and Ofatumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
22 sitesItaly
Study dates
5 Nov 2013to Oct 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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • B-cell CLL diagnosis by 2008 revised IWCLL criteria.
  • Treatment requirement according to the 2008 revised IWCLL criteria.
  • No previous treatment.
  • Age > 18 year and . 65 years.
  • ECOG performance status of 0-1 at study entry and CIRS score .6.
  • Adequate renal function (creatinine clearance.60 ml/min estimated using the Cockcroft-Gaultequation) .
  • For male and female subjects of childbearing potential, agreement to use effective contraception.
  • Signed written informed const according to ICH/EU/GCP and national local laws.

Who cannot join

  • Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease and/or laboratory abnormality which in the opinion of the investigator may represent a risk for the patient and/or that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females.
  • Known positive serology for HIV.
  • Positive serology for Hepatitis B (HBV) defined as a positive test for HBsAg and HBV-DNA.
  • HCV-RNA positive.
  • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection, tuberculosis and active hepatitis.
Show all 17Show fewer
  • History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
  • Known presence of alcohol and/or drug abuse.
  • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to the inclusion in the study, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy.. grade 2 neuropathy; history of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae.
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
  • One or more laboratory abnormalities:
  • Calculated creatinine clearance (Cockroft-Gault)<60mL/min.
  • Absolute granulocyte count <1500/ƒÊL not disease related.
  • Platelet count < 75000/ƒÊL not disease related.
  • GOT, GPT, GT, alkaline phosphatase > 1,5 x upper limit of normal value unless due to disease involvement); serum bilirubin >1.5mg/dL, subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones)
  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Italy22 sites

  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

    Alessandria

  • Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"

    Ascoli Piceno

  • S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti

    Asti

  • ASL12 - Biella Ospedale degli Infermi - Dip. di Medicina e Geriatria - Struttura Complessa di Medicina Interna

    Biella

  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

    Catanzaro

  • Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna

    Ferrara

  • RCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente

    Genova

  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

    Lecce

  • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

    Messina

  • Ospedale Niguarda " Ca Granda"

    Milan

  • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

    Novara

  • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"

    Palermo

  • Cattedra di Ematologia CTMO Università degli Studi di Parma

    Parma

  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

    Reggio Calabria

  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

    Reggio Emilia

  • Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo

    Roma

  • Policlinico Umberto I, Hematology Department - Sapienza

    Roma

  • U.O.C. Ematologia - Ospedale S.Eugenio

    Roma

  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"

    Siena

  • SS.C. di Oncoematologia - Dipartimento di Medicina Clinica e Sperimentale - Azienda Ospedaliera - S. Maria Di Terni

    Terni

  • Div. di Ematologia Ospedale "S.Giovanni Battista"

    Torino

  • Clinica Ematologica - Policlinico Universitario

    Udine

Other trials in Italy

About this study

Official title: Phase 2 Multicenter, Study to Assess the Efficacy and the Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab (FCO2) Chemoimmunotherapy in Young (≤65 Yrs) Patients With Chronic Lymphocytic Leukemia (CLL).

Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined with ofatumumab (FCO2) in previously untreated "young" patients with Chronic Lymphocytic Leukemia (CLL).

Read the detailed description

Given that:

  • rituximab, fludarabine and cyclophosphamide (FCR) front-line treatment was associated with a high OR rate, superior PFS and OS as compared to fludarabine and cyclophosphamide regimen;
  • a direct relationship between the dose of rituximab and the response rate has been reported;
  • ofatumumab, as single agent, proved activity in CLL patients with refractory disease;
  • ofatumumab, fludarabine and cylophosphamide (O-FC) front-line treatment has been associated with a high complete response (CR) rate;
  • the expected grade 3-4 granulocytopenia could led to reduce the dose intensity of study drugs (FC) and increase the infection rate; a schedule combining FC with an increased dose of ofatumumab associated to primary phrophylaxis of granulocytopenia could be associated with an improvement in the CR rate. The purpose of this study is to determine whether we could improve the CR rate of the golden standard treatment for fit patients with CLL , the FCR regimen, with a chemoimmunotherapy including FC combined with an increased dose of the monoclonal antibody ofatumumab, given every other week (FCO2) associated with a primary prophylaxis of granulocytopenia.
Being tested
Cyclophosphamide, Fludarabine, Ofatumumab
Keywords
CLL, Fludarabine, Cyclophosphamide, Ofatumumab

What participants receive

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

Study groups in NCT01762202
Study groupRoleWhat they receive
Study therapyExperimentalNot described
Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Ofatumumab

What is being measured

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

  1. Number of complete responses.

    The complete response (CR) rate after FCO2 front-line treatment.

    Measured: After 8 months from study entry.

Secondary outcomes (6)

  1. Number of overall responses.

    Overall Response (OR) rate after FCO2 front-line treatment.

    Measured: After 8 months from study entry.

  2. Number of patients in progression-free survival.

    Progression-free survival (PFS) calculated from the date of first treatment dose - induction phase - until the date of the first documentation of progressive disease or until death (whatever the cause), whichever occurs first. Patients still alive and known to be progression free will be censored at the moment of last follow-up.

    Measured: After 32 months from study entry.

  3. Number of patients needing a new CLL Treatment.

    Time to a new CLL treatment (TTT) will be calculated from the date of last treatment dose until date of a new treatment received for CLL, where death occurred before the new treatment will be considered as competing risk. Patients still alive without receiving a new treatment will be censored at the time of the last follow-up.

    Measured: After 32 months from study entry.

  4. Number of patients in overall survival

    Overall survival (OS): defined as the time interval between the date of first treatment dose - induction phase- and the date of death for any cause; patients still alive will be censored at the moment of last follow-up.

    Measured: After 32 months from study entry.

  5. Number of toxic events.

    Toxicity of treatment according the last NCI criteria.

    Measured: After 32 months from study entry.

  6. Outcome of patients according to clinical and biologica variables.

    Outcome of patients (response, PFS OS) according to clinical and biologic variables (age; size of nodes, 2-microglobulin, lymphocyte count, stage, IgVH, p53, FISH, ZAP-70, CD38, FLCs).

    Measured: After 32 months from study entry.

Timeline

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

  1. First posted7 Jan 2013 (estimated)
  2. Study start5 Nov 2013
  3. Primary completionNov 2015
  4. Study completionOct 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
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01762202
Sponsor's protocol ID
CLL0911
Other IDs
2011-005329-27
Acronym
CLL0911
Status last verified
Oct 2020
First submitted
4 Jan 2013
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide, Fludarabine and Ofatumumab in people with B-cell Lymphoid Leukemia and Young Patients, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 22 sites in Italy.

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 17 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Italy. 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?

Number of complete responses. (time frame: After 8 months from study entry.). 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 NCT01762202.

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 14 Oct 2020.

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