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

Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases

Intervention: therapeutic immune globulin (Biological); busulfan (Drug); fludarabine phosphate (Drug); allogeneic hematopoietic stem cell transplantation (Procedure)

Phase: Phase 2

Status: Recruiting

Sponsored by: Institut Paoli-Calmettes

Official(s) and/or principal investigator(s):
Didier Blaise, MD, Affiliation: Institut Paoli-Calmettes


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.

Clinical Details

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 design: Treatment, Non-Randomized, Open Label

Primary outcome: Allogeneic hematopoietic stem cell transplant-related mortality

Detailed description: OBJECTIVES:


- 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.


- To study the usual clinical and biological aspects of the transplantation in these


- 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


- 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.


Minimum age: 56 Years. Maximum age: 74 Years. Gender(s): Both.



- Diagnosis of a hematological malignancy

- Candidate for an allogeneic hematopoietic stem cell transplantation

- Available HLA-identical related donor


- 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


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

Locations and Contacts

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2007
Last updated: July 7, 2009

Page last updated: October 19, 2009

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