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

Sponsored by:	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00806767

Purpose

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	Intervention	Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	Drug: busulfan Drug: fludarabine phosphate Drug: therapeutic immune globulin Procedure: allogeneic hematopoietic stem cell transplantation	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma

Drug Information available for: Fludarabine Fludarabine monophosphate Immunoglobulins Globulin, Immune Busulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Allogeneic hematopoietic stem cell transplant-related mortality [ Designated as safety issue: Yes ]

Estimated Enrollment:	82
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	56 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806767

Locations

France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Recruiting
Marseille, France, 13273
Contact: Didier Blaise, MD 33-4-91-22-37-54 blaised@marseille.fnclcc.fr

Sponsors and Collaborators

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

Investigators

Investigator:

Didier Blaise, MD

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000626779, IPC-2005-004, EUDRACT-2005-005051-17, IPC-T2A, INCA-RECF0452
Study First Received:	December 10, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00806767
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma

stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Study placed in the following topic categories:

Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Mycoses
Preleukemia
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasm Metastasis
Rho(D) Immune Globulin

Acute myeloid leukemia, adult
Hodgkin Disease
Immunoglobulins
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Blood Coagulation Disorders
Acute myelogenous leukemia
Myeloproliferative Disorders

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009