Clinical trial NCT00806767: Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Keywords: 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
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
recurrent mycosis fungoides/Sezary syndrome
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia, BCR-ABL1 negative
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
chronic eosinophilic leukemia
primary myelofibrosis
chronic neutrophilic leukemia
de novo myelodysplastic syndromes
myelodysplastic/myeloproliferative neoplasm, unclassifiable
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-12-11
Enrollment: 82
Sex: ALL
Minimum age (years): 56
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Allogeneic hematopoietic stem cell transplant-related mortality
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Didier Blaise, MD
References: