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Completed

NCT Number: NCT00644371

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

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.

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Key information

Conditions

Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

H. Santa Creu i Sant Pau., Barcelona, Barcelona., Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • 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
  • 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
  • Stable disease at the time of transplantation
  • Age between 18 and 65
  • Performance status (ECOG) ≤ 2
  • Normal and suitable pulmonary function (DLCO ≥ 30%)
  • Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40%
  • 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

  • Prior treatment with radiopharmaceutical agents
  • HIV-associated lymphoma
  • Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA)
  • Patient's inability to follow the protocol
  • Hypersensitivity to 90Y-itritumomab tiuxetan
  • Presence of severe pathologies that preclude chemotherapeutic treatment
  • Pregnant women or pregnancy risk due to inappropriate contraceptive measures
  • Breastfeeding women

Treatment and study plan

Ibritumomab Tiuxetan (Zevalin)

Drug

Conditioning Regimen

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

Other names: Rituximab (Mabthera)

Primary outcomes

  1. progression-free survival

    Time frame: 12 months

Secondary outcomes

  1. safety (toxicity, transplantation- and graft-related mortality)

    Time frame: 36 months

  2. response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).

    Time frame: 36 months

  3. overall survival

    Time frame: 36 months

  4. relapse rate

    Time frame: 36 months

  5. acute and chronic Graft-versus-Host Disease

    Time frame: 36 months

  6. haematological and immunological reconstitution, and chimerism.

    Time frame: Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.

  7. the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Other

Registry information

Official study title

Allogeneic Transplantation of Haematopoietic Stem Cells Following Non-myeloablative Conditioning With Melphalan, Fludarabine, Thiotepa, Rituximab and Ibritumomab Tiuxetan (Zevalin) in Patients With Aggressive Non-Hodgkin's B-cell Lymphoma

Acronym: Z-RIC-Allo

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Mar 26, 2008
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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