Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation
Phase 2
1 Year
80 Years
1 Year
80 Years
Open (Enrolling)
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Trial Information
Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation
OBJECTIVES:
- Determine the hematopoietic recovery in patients with hematologic malignancies or
genetic disorders treated with fludarabine and melphalan followed by allogeneic or
syngeneic bone marrow or peripheral blood stem cell transplantation.
- Determine the chemotherapeutic toxicity of this regimen in these patients.
- Determine the relapse and survival of patients treated with this regimen.
- Determine the incidence of graft-versus-host disease in patients treated with this
regimen.
OUTLINE: Patients receive fludarabine IV on days -6 to -2 and melphalan IV on days -3 and
-2. Patients with a non-HLA-identical family member may also receive anti-thymocyte globulin
on days -4 to -1. Patients undergo allogeneic or syngeneic bone marrow or peripheral blood
stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis
comprising mycophenolate mofetil twice daily beginning on day -3, methylprednisolone
beginning on day 5 and continuing over 8 weeks, and cyclosporine IV or orally beginning on
day -3 and continuing until at least 6 months post-transplantation.
Patients are followed at 1, 3, and 6 months, and then at 1 year post-transplantation.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 5-6 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Clinically and/or histologically confirmed hematologic malignancy or genetic disorder
- Chronic myelogenous leukemia
- Typical blood and marrow morphology
- Presence of Philadelphia chromosome OR
- Molecular evidence of bcr/abl rearrangement if Philadelphia
chromosome-negative
- Acute myeloid leukemia, acute lymphocytic leukemia, myelodysplasia, or lymphoma
- High risk of relapse or progressive disease
- Typical clinical features and morphology in blood, marrow, lymph node, or
other tissue by cytochemistry, immunophenotyping, and/or chromosomal
abnormalities
- Multiple myeloma
- Typical marrow morphology, radiographic findings, and paraprotein
- Aplastic anemia
- Typical marrow and blood findings
- Genetic disorder including storage disease (e.g., adrenoleukodystrophy),
hemoglobinopathies (e.g., thalassemia), or severe immunodeficiency
- Unwilling to undergo conventional high-dose chemoradiotherapeutic conditioning prior
to allogeneic stem cell transplantation OR
- Presence of other medical disorder which precludes high-dose chemoradiotherapeutic
conditioning (e.g., cardiac disease or infection)
- Syngeneic twin, HLA-identical, or 1 or 2 HLA antigen-mismatched family member or
unrelated donor
PATIENT CHARACTERISTICS:
Age:
- 1 to 80
Performance status:
- Karnofsky 50-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other serious medical or psychiatric illness that would preclude study compliance
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Hematopoietic recovery
Safety Issue:
No
Principal Investigator
David G. Savage, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Herbert Irving Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068396
NCT ID:
NCT00008307
Start Date:
April 1998
Completion Date:
Related Keywords:
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- recurrent childhood acute lymphoblastic leukemia
- recurrent adult Hodgkin lymphoma
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- stage I childhood lymphoblastic lymphoma
- stage II childhood lymphoblastic lymphoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- recurrent childhood lymphoblastic lymphoma
- recurrent childhood acute myeloid leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult acute lymphoblastic leukemia
- relapsing chronic myelogenous leukemia
- chronic phase chronic myelogenous leukemia
- accelerated phase chronic myelogenous leukemia
- blastic phase chronic myelogenous leukemia
- meningeal chronic myelogenous leukemia
- untreated adult acute lymphoblastic leukemia
- untreated adult acute myeloid leukemia
- untreated childhood acute myeloid leukemia and other myeloid malignancies
- untreated childhood acute lymphoblastic leukemia
- adult acute myeloid leukemia in remission
- adult acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- childhood acute lymphoblastic leukemia in remission
- chronic myelogenous leukemia, BCR-ABL1 positive
- Philadelphia chromosome negative chronic myelogenous leukemia
- stage II childhood Hodgkin lymphoma
- stage I childhood Hodgkin lymphoma
- stage III childhood Hodgkin lymphoma
- stage IV childhood Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I adult Burkitt lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- intraocular lymphoma
- stage I childhood large cell lymphoma
- stage II childhood large cell lymphoma
- stage III childhood large cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood large cell lymphoma
- stage I mantle cell lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous 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 adult diffuse small cleaved cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- childhood chronic myelogenous leukemia
- contiguous stage II small lymphocytic lymphoma
- contiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- childhood myelodysplastic syndromes
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
