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

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Completed

CT.gov ID

NCT00806767

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms	Biological: therapeutic immune globulin Drug: busulfan Drug: fludarabine phosphate Procedure: allogeneic hematopoietic stem cell transplantation	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

Allogeneic hematopoietic stem cell transplant-related mortality []

Eligibility Criteria

Criteria

Ages Eligible for Study:

56 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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