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

Phase 2
18 Years
70 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

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Trial Information

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

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

- 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

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.

Type of Study:


Study Design:

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

Outcome Measure:

Disease clinical response to treatment - complete response rate.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Javier Briones, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

January 2008

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Z-BEAM
  • Autologous
  • Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin