Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)

• Registration Number: NCT00646750
• Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-28
• Primary Completion: 2010-02
• Study Completion: 2012-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-12
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)	BEAM preceded by Ybritumomab Tiuxetan (Zevalin)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.	36 months
Overall response rate (complete + partial response)	36 month
Overall survival	96 months
Post-transplantation haematological and immunological reconstitution	Until post-transplantation day +100
Progression-free-survival	36 month

Trial Locations

Locations (18)

H.U. La Princesa; 🇪🇸 Madrid, Spain

H. Morales Messeguer; 🇪🇸 Murcia, Spain

Hospital Universitario de Alicante; 🇪🇸 Alicante, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

H. Reina Sofía; 🇪🇸 Córdoba, Spain

H.U. Central de Asturias, Oviedo; 🇪🇸 Oviedo, Asturias, Spain

H.U. Gregorio Marañón,; 🇪🇸 Madrid, Spain

Clínica Puerta de Hierro,; 🇪🇸 Madrid, Spain

H. de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

H.U. Marqués de Valdecilla; 🇪🇸 Santander, Spain

H.Universitario de Canarias; 🇪🇸 Santa Cruz de Tenerife, Canarias, Spain

Instituto Catalán de Oncología,; 🇪🇸 Barcelona, Spain

H.U. 12 de Octubre,; 🇪🇸 Madrid, Spain

H.U. La Paz; 🇪🇸 Madrid, Spain

H.U. Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

M.D. Anderson Internacional; 🇪🇸 Madrid, Spain

H. Clínico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

H.U. La Fe; 🇪🇸 Valencia, Spain