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

NCT ID: NCT00646750

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-06-30

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.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

BEAM preceded by Ybritumomab Tiuxetan (Zevalin)

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

Other Intervention Names

Ybritumomab Tiuxetan (Zevalin); Rituximab (Mabthera)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Briones, MD

Role: PRINCIPAL_INVESTIGATOR

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

Dolores Caballero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario de Salamanca

Locations

Hospital Universitario de Alicante

Alicante, Alicante, Spain

H. de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Instituto Catalán de Oncología,

Barcelona, Barcelona, Spain

H.Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

H.U. Marqués de Valdecilla

Santander, Cantabria, Spain

H. Reina Sofía

Córdoba, Córdoba, Spain

Clínica Puerta de Hierro,

Madrid, Madrid, Spain

H.U. 12 de Octubre,

Madrid, Madrid, Spain

H.U. Gregorio Marañón,

Madrid, Madrid, Spain

H.U. La Paz

Madrid, Madrid, Spain

H.U. La Princesa

Madrid, Madrid, Spain

M.D. Anderson Internacional

Madrid, Madrid, Spain

H. Morales Messeguer

Murcia, Murcia, Spain

H.U. Virgen de la Arrixaca

Murcia, Murcia, Spain

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

H.U. Central de Asturias, Oviedo

Oviedo, Principality of Asturias, Spain

H. Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain

H.U. La Fe

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

EudraCT No.: 2007-003198 - 22

Identifier Type: -

Identifier Source: secondary_id

GELTAMO-Z-BEAM LDGGB

Identifier Type: -

Identifier Source: org_study_id