Clinical trial NCT00646750: Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom
Official title: Autologous Transplantation of Haematopoietic Stem Cells With Conditioning Including Zevalin + BEAM to Patients Suffering From Refractory Large B-cell Diffuse Lymphom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: Z-BEAM
Autologous
Lymphoma
GELTAMO
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Give their written informed consent.
2. 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).
3. Stable disease at the time of transplantation.
4. Age ≥ 18 but ≤ 70.
5. 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.:

1. Performance status (ECOG) \< 3.
2. FEV1, DLCO and FVC ≥ 50% of the normal theoretical values.
3. Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%.
4. Total bilirubin and transaminases \< 3 times the normal maximum value, except if attributable to the underlying disease.
5. Creatinine \< 2 times the maximum normal value, and creatinine clearance \> 40 ml/min, except if attributable to the underlying disease.
6. Absence of symptomatic heart disease, cirrhosis or active B or C virus hepatitis.
7. HIV negative.

Exclusion Criteria:

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

Primary outcomes:
measure: Disease clinical response to treatment - complete response rate.
timeFrame: Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation
Secondary outcomes:
measure: Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.
timeFrame: 36 months
measure: Overall response rate (complete + partial response)
timeFrame: 36 month
measure: Progression-free-survival
timeFrame: 36 month
measure: Overall survival
timeFrame: 96 months
measure: Post-transplantation haematological and immunological reconstitution
timeFrame: Until post-transplantation day +100
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: H.U. Central de Asturias, Oviedo
state: Asturias
city: Santa Cruz de Tenerife
country: Spain
facility: H.Universitario de Canarias
state: Canarias
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Alicante
country: Spain
facility: Hospital Universitario de Alicante
city: Barcelona
country: Spain
facility: H. de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Instituto Catalán de Oncología,
city: Córdoba
country: Spain
facility: H. Reina Sofía
city: Madrid
country: Spain
facility: Clínica Puerta de Hierro,
city: Madrid
country: Spain
facility: H.U. 12 de Octubre,
city: Madrid
country: Spain
facility: H.U. Gregorio Marañón,
city: Madrid
country: Spain
facility: H.U. La Paz
city: Madrid
country: Spain
facility: H.U. La Princesa
city: Madrid
country: Spain
facility: M.D. Anderson Internacional
city: Murcia
country: Spain
facility: H. Morales Messeguer
city: Murcia
country: Spain
facility: H.U. Virgen de la Arrixaca
city: Salamanca
country: Spain
facility: H. Clínico Universitario de Salamanca
city: Santander
country: Spain
facility: H.U. Marqués de Valdecilla
city: Valencia
country: Spain
facility: H.U. La Fe
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Javier Briones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario de Salamanca
name: Dolores Caballero, MD
role: PRINCIPAL_INVESTIGATOR
References: