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

NCT ID: NCT00806767

Last Updated: 2011-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

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.

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.

Conditions

Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

therapeutic immune globulin

Intervention Type: BIOLOGICAL

busulfan

Intervention Type: DRUG

fludarabine phosphate

Intervention Type: DRUG

allogeneic hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 56 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Principal Investigators

Didier Blaise, MD

Role:

Institut Paoli-Calmettes

Locations

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

Marseille, , France

Countries

France

Other Identifiers

IPC-2005-004

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2005-005051-17

Identifier Type: -

Identifier Source: secondary_id

IPC-T2A

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0452

Identifier Type: -

Identifier Source: secondary_id

CDR0000626779

Identifier Type: -

Identifier Source: org_study_id