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

Non-Hodgkin's Lymphoma Clinical Trial

— Z-BEAM LDGGB  

Official title:

Autologous Transplantation of Haematopoietic Stem Cells With Conditioning Including Zevalin + BEAM to Patients Suffering From Refractory Large B-cell Diffuse Lymphom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646750
• Other study ID #: GELTAMO-Z-BEAM LDGGB
• Secondary ID: EudraCT No.: 200
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2008
• Last updated: February 12, 2016
• Start date: January 2008
• Est. completion date: June 2012

Study information

• Verified date: February 2016
• Source: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Alicante	Alicante
Spain	H. de la Santa Creu i Sant Pau	Barcelona
Spain	Instituto Catalán de Oncología,	Barcelona
Spain	H. Reina Sofía	Córdoba
Spain	Clínica Puerta de Hierro,	Madrid
Spain	H.U. 12 de Octubre,	Madrid
Spain	H.U. Gregorio Marañón,	Madrid
Spain	H.U. La Paz	Madrid
Spain	H.U. La Princesa	Madrid
Spain	M.D. Anderson Internacional	Madrid
Spain	H. Morales Messeguer	Murcia
Spain	H.U. Virgen de la Arrixaca	Murcia
Spain	H.U. Central de Asturias, Oviedo	Oviedo	Asturias
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	H. Clínico Universitario de Salamanca	Salamanca
Spain	H.Universitario de Canarias	Santa Cruz de Tenerife	Canarias
Spain	H.U. Marqués de Valdecilla	Santander
Spain	H.U. La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease clinical response to treatment - complete response rate.		Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation	No
Secondary	Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.		36 months	Yes
Secondary	Overall response rate (complete + partial response)		36 month	No
Secondary	Progression-free-survival		36 month	No
Secondary	Overall survival		96 months	No
Secondary	Post-transplantation haematological and immunological reconstitution		Until post-transplantation day +100	No