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

NCT01762202 | Completed Phase 2

• 2 other identifiers: CLL09112011-005329-27
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 22

Brief 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).

Conditions

B-cell Lymphoid Leukemia; Young Patients

Keywords

CLL; Fludarabine; Cyclophosphamide; Ofatumumab

Outcome Measures

Primary Outcomes (1)

• Number of complete responses.

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

  After 8 months from study entry.

Secondary Outcomes (6)

• Number of overall responses.

  After 8 months from study entry.

• Number of patients in progression-free survival.

  After 32 months from study entry.

• Number of patients needing a new CLL Treatment.

  After 32 months from study entry.

• Number of patients in overall survival

  After 32 months from study entry.

• Number of toxic events.

  After 32 months from study entry.

Study Arms (1)

Study therapy

EXPERIMENTAL

Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Ofatumumab

Interventions

Cyclophosphamide DRUG

Study therapy

Fludarabine DRUG

Study therapy

Ofatumumab DRUG

Study therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (22)

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

Alessandria, Italy

Location

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

Ascoli Piceno, Italy

Location

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

Asti, Italy

Location

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

Biella, Italy

Location

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

Catanzaro, Italy

Location

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

Ferrara, Italy

Location

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

Genova, Italy

Location

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

Lecce, Italy

Location

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

Messina, Italy

Location

Ospedale Niguarda " Ca Granda"

Milan, Italy

Location

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

Novara, Italy

Location

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

Palermo, Italy

Location

Cattedra di Ematologia CTMO Università degli Studi di Parma

Parma, Italy

Location

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

Reggio Calabria, Italy

Location

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, Italy

Location

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

Roma, Italy

Location

Policlinico Umberto I, Hematology Department - Sapienza

Roma, Italy

Location

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

Roma, Italy

Location

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

Siena, Italy

Location

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

Terni, Italy

Location

Div. di Ematologia Ospedale "S.Giovanni Battista"

Torino, Italy

Location

Clinica Ematologica - Policlinico Universitario

Udine, Italy

Location

Related Links

• GIMEMA Foundation website

MeSH Terms

Interventions

Cyclophosphamide; fludarabine; ofatumumab

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Roberto Foà, Pr.

  Policlinico Umberto I, Hematology Department.

  STUDY CHAIR

• Francesca R. Mauro

  Policlinico Umberto I, Hematology Department.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 7, 2013
• Study Start: November 5, 2013
• Primary Completion: November 1, 2015
• Study Completion: October 1, 2018
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (22)