NCT00646750

Brief Summary

To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

2.1 years

First QC Date

March 17, 2008

Last Update Submit

February 12, 2016

Conditions

Non-Hodgkin's Lymphoma

Keywords

Z-BEAMAutologousLymphomaGELTAMO

Outcome Measures

Primary Outcomes (1)

  • Disease clinical response to treatment - complete response rate.

    Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation

Secondary Outcomes (5)

  • Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.

    36 months

  • Overall response rate (complete + partial response)

    36 month

  • Progression-free-survival

    36 month

  • Overall survival

    96 months

  • Post-transplantation haematological and immunological reconstitution

    Until post-transplantation day +100

Study Arms (1)

1

EXPERIMENTAL

BEAM preceded by Ybritumomab Tiuxetan (Zevalin)

Drug: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)

Interventions

Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)DRUG

Day -21: rituximab. 250 mg/m2 iv Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi). Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1.

Also known as: Ybritumomab Tiuxetan (Zevalin), Rituximab (Mabthera)
1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Give their written informed consent.
  • Abide by at least one of the following conditions:
  • Obtain no partial response after first-line chemotherapy including anthracyclines + rituximab (R-CHOP, R-MegaCHOP, R-EPOCH or the like), or else
  • Absence of partial response after having received salvage (post-induction) chemotherapy including R-IFE, R-ESHAP, R-ICE or the like.
  • Patients on first recidivation who do not attain partial remission after salvage chemotherapy.
  • Patients with transformed lymphoma, on first partial remission (No CR).
  • Stable disease at the time of transplantation.
  • Age ≥ 18 but ≤ 70.
  • Life expectancy of greater than three months.
  • Additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.:
  • Performance status (ECOG) \< 3.
  • FEV1, DLCO and FVC ≥ 50% of the normal theoretical values.
  • Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%.
  • Total bilirubin and transaminases \< 3 times the normal maximum value, except if attributable to the underlying disease.
  • Creatinine \< 2 times the maximum normal value, and creatinine clearance \> 40 ml/min, except if attributable to the underlying disease.
  • +2 more criteria

You may not qualify if:

  • Impossibility of collecting, via apheresis, a number of CD34+ cells ≥ 2 x 106/kg.
  • Known hypersensitivity to mouse proteins.
  • Involvement of CNS by lymphoma.
  • Progressive lymphoma during the month prior to the date of transplantation.
  • Previous radioimmunotherapy.
  • Previous autologous transplantation of haematopoietic stem cells.
  • Pregnant or breastfeeding women, or adults of childbearing age who are not using an effective contraceptive method.
  • Being submitted to treatment in a clinical trial for 30 days prior to entry in this trial.
  • Active psychiatric disease, including addiction disorders.
  • Existence of active not-haematopoietic neoplasia, with the exception of cutaneous basal carcinoma or cervix intraepithelial carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Hospital Universitario de Alicante

Alicante, Alicante, Spain

Location

H. de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

Instituto Catalán de Oncología,

Barcelona, Barcelona, Spain

Location

H.Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Location

H.U. Marqués de Valdecilla

Santander, Cantabria, Spain

Location

H. Reina Sofía

Córdoba, Córdoba, Spain

Location

Clínica Puerta de Hierro,

Madrid, Madrid, Spain

Location

H.U. 12 de Octubre,

Madrid, Madrid, Spain

Location

H.U. Gregorio Marañón,

Madrid, Madrid, Spain

Location

H.U. La Paz

Madrid, Madrid, Spain

Location

H.U. La Princesa

Madrid, Madrid, Spain

Location

M.D. Anderson Internacional

Madrid, Madrid, Spain

Location

H. Morales Messeguer

Murcia, Murcia, Spain

Location

H.U. Virgen de la Arrixaca

Murcia, Murcia, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Location

H.U. Central de Asturias, Oviedo

Oviedo, Principality of Asturias, Spain

Location

H. Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain

Location

H.U. La Fe

Valencia, Valencia, Spain

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma

Interventions

ibritumomab tiuxetanRituximabCarmustineEtoposideMelphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino Acids

Study Officials

  • Javier Briones, MD

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

  • Dolores Caballero, MD

    Hospital Clínico Universitario de Salamanca

    PRINCIPAL INVESTIGATOR

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

March 17, 2008

First Posted

March 28, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2010

Study Completion

June 1, 2012

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations

ES(18)