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NCT Number: NCT00806767

Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antilymphocyte globulin before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte globulin together with donor stem cell transplant works in treating older patients with hematological cancer.

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Key information

Conditions

Chronic Myeloproliferative Disorders Blast Crisis Blood Protein Disorders Bone Marrow Diseases Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasms Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Neoplastic Processes Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Sezary Syndrome Tumor Virus Infections Vascular Diseases Virus Diseases

Age range

56 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

About this study

OBJECTIVES:

Primary

  • To assess non-relapse or progression-related mortality at 1 year in patients over 55 with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation from a matched related, filgrastim (G-CSF)-mobilized donor and treated with conditioning comprising fludarabine phosphate, busulfan, and anti-lymphocyte globulin.
  • To assess the incidence of graft-versus-host disease in these patients.
  • To assess the incidence of relapse in these patients.
  • To assess cellular recovery in these patients.
  • To assess myeloid and lymphocyte chimerism in these patients.

Secondary

  • To study the usual clinical and biological aspects of the transplantation in these patients.
  • To study the impact of the Charlson score and the suitability for allogeneic transplantation score on mortality and 1-year survival.
  • To assess the quality of life (QLQ-C30) of these patients.
  • To study the economic cost of transplantation from conditioning to 1 year post-transplant.
  • To study the mobilization and collection of progenitor stem cells in the donors.
  • To study the psychological impact of donating stem cells on the donors.

OUTLINE: This is a multicenter study.

  • Conditioning: Patients receive fludarabine phosphate IV over 30 minutes on days -5 through -1, busulphan IV over 2 hours every 6 hours on days -4 and -3, and anti-lymphocyte globulin IV over 4 hours on days -2 and -1.
  • Transplantation: Patients undergo allogeneic hematopoietic stem call transplantation on day 0.

Patients complete a quality of life survey (QLQ-C30). After completion of study treatment, patients are followed every month for 6 months and then every 3 months for 6 months.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Diagnosis of a hematological malignancy
  • Candidate for an allogeneic hematopoietic stem cell transplantation
  • Available HLA-identical related donor

PATIENT CHARACTERISTICS:

  • WHO performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Life expectancy > 6 months
  • LVEF ≥ 40%
  • DLCO ≥ 50%
  • Creatinine clearance ≥ 30 mL/min
  • Transaminases and/or bilirubin ≤ 2 times upper limit of normal (ULN)
  • No other cancer within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No human T-cell leukemia virus type 1 positivity
  • No HIV positivity
  • No uncontrolled bacterial, viral, or fungal infection
  • No contraindications to the study drugs
  • No concurrent serious and uncontrolled disease

PRIOR CONCURRENT THERAPY:

  • At least 1 month since prior participation in a clinical trial

Treatment and study plan

therapeutic immune globulin

Biological

busulfan

Drug

fludarabine phosphate

Drug

allogeneic hematopoietic stem cell transplantation

Procedure

Primary outcomes

  1. Allogeneic hematopoietic stem cell transplant-related mortality

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies

Important dates

Study start
2007
Primary completion
2011
First posted
Dec 11, 2008
Registry last updated
May 17, 2011

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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