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

Lymphoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806767
• Other study ID #: CDR0000626779
• Secondary ID: IPC-2005-004EUDR
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2008
• Last updated: May 14, 2011
• Start date: March 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 56 Years to 74 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia

Intervention

Biological:
• therapeutic immune globulin

Drug:
• busulfan

• fludarabine phosphate

Procedure:
• allogeneic hematopoietic stem cell transplantation

Locations

Country	Name	City	State
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allogeneic hematopoietic stem cell transplant-related mortality			Yes