Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)

NCT ID: NCT00644371

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2013-02-04

Brief Summary

To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.

Conditions

Non-Hodgkin Lymphoma

Study Design

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

Study Groups

1

Group Type: EXPERIMENTAL

Ibritumomab Tiuxetan (Zevalin)

Intervention Type: DRUG

Conditioning Regimen

1. Rituximab, 250 mg/m2 on days -21 and -14.

2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.

Chemotherapy:

• Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
• Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion.

Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months:

• Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8.
• Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
• Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.

Interventions

Ibritumomab Tiuxetan (Zevalin)

Conditioning Regimen

1. Rituximab, 250 mg/m2 on days -21 and -14.

2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.

Chemotherapy:

• Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
• Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion.

Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months:

• Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8.
• Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
• Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.

Intervention Type: DRUG

Other Intervention Names

Rituximab (Mabthera)

Eligibility Criteria

Inclusion Criteria

1. Written informed consent

2. Histologically confirmed B-cell lymphoma of the following subtypes:

• LBCDL
• Grade 3b follicular lymphoma
• Mantle-cell lymphoma
• Transformed B-cell lymphoma
• Burkitt lymphoma in patients not eligible for a conventional allogeneic transplant

3. High-risk B-cell CD20+ lymphoma defined by

• Having attained less than PR after two chemotherapy lines
• Post-transplantation relapse
• Presence of disease detected through a metabolic approach (PET/CT or else CT+PET) either before or after autologous transplantation
• Inability to collect enough stem cells for autologous transplantation

4. Stable disease at the time of transplantation

5. Age between 18 and 65

6. Performance status (ECOG) ≤ 2

7. Normal and suitable pulmonary function (DLCO ≥ 30%)

8. Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40%

9. Normal hepatic and renal function, with creatinine ≤ 2 mg/dl and Bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x UNL ; AST, ALT ≤ 2.5 x UNL (≤ 5 x UNL if hepatic infiltration)

Exclusion Criteria

1. Prior treatment with radiopharmaceutical agents

2. HIV-associated lymphoma

3. Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA)

4. Patient's inability to follow the protocol

5. Hypersensitivity to 90Y-itritumomab tiuxetan

6. Presence of severe pathologies that preclude chemotherapeutic treatment

7. Pregnant women or pregnancy risk due to inappropriate contraceptive measures

8. Breastfeeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Dolores Caballero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario de Salamanca

Locations

H. Santa Creu i Sant Pau.

Barcelona, Barcelona., Spain

H. U. Marqués de Valdecilla.

Santander, Cantabria, Spain

H.U. 12 de Octubre

Madrid, Madrid, Spain

H.U. Gregorio Marañón

Madrid, Madrid, Spain

H.U. La Princesa

Madrid, Madrid, Spain

H.U. Ramón y Cajal.

Madrid, Madrid, Spain

H. Morales Meseguer.

Murcia, Murcia, Spain

H. Virgen de la Arrixaca

Murcia, Murcia, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

H. Central de Asturias

Oviedo, Oviedo, Spain

H. Clinico de Salamanca

Salamanca, Salamanca, Spain

H. Clínico Valencia

Valencia, Valencia, Spain

H. La Fe

Valencia, Valencia, Spain

H.U. Miguel Servet

Zaragoza, Zaragoza., Spain

Countries

Spain

References

Cabrero M, Martin A, Briones J, Gayoso J, Jarque I, Lopez J, Grande C, Heras I, Arranz R, Bernal T, Perez-Lopez E, Lopez-Godino O, Conde E, Caballero D. Phase II Study of Yttrium-90-Ibritumomab Tiuxetan as Part of Reduced-Intensity Conditioning (with Melphalan, Fludarabine +/- Thiotepa) for Allogeneic Transplantation in Relapsed or Refractory Aggressive B Cell Lymphoma: A GELTAMO Trial. Biol Blood Marrow Transplant. 2017 Jan;23(1):53-59. doi: 10.1016/j.bbmt.2016.10.003. Epub 2016 Oct 19.

Reference Type: DERIVED

PMID: 27771496 (View on PubMed)

Other Identifiers

EuDRACT nº:2007-003302-10

Identifier Type: -

Identifier Source: secondary_id

GELTAMO-Z-RIC-Allo

Identifier Type: -

Identifier Source: org_study_id