Combination Chemotherapy Followed by Donor Bone Marrow Tr... | NCT00008307 | Trialant
NCT00008307
Sponsor
Herbert Irving Comprehensive Cancer Center
Status
Unknown status
Last Update Posted
Jan 6, 2014Estimated
Enrollment
52Estimated
Phase
Phase 2
Conditions
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions
anti-thymocyte globulin
cyclosporine
fludarabine phosphate
melphalan
methylprednisolone
mycophenolate mofetil
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
syngeneic bone marrow transplantation
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00008307
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000068396
Secondary IDs
ID
Type
Description
Link
CPMC-IRB-8462
CPMC-IRB-CAMP-25
NCI-G00-1897
Brief Title
Combination Chemotherapy Followed by Donor Bone Marrow Transplant or Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Genetic Disorders
Official Title
Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Apr 2006
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Active, not recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 1998
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Jan 6, 2001
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 3, 2014
Last Update Posted Date
Jan 6, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Herbert Irving Comprehensive Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Giving chemotherapy drugs, such as fludarabine and melphalan, before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by donor bone marrow transplant or peripheral stem cell transplant works in treating patients with hematologic cancer or genetic disorders.
Detailed Description
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.
Conditions Module
Conditions
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
52Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
anti-thymocyte globulin
Biological
cyclosporine
Drug
fludarabine phosphate
Drug
melphalan
Drug
methylprednisolone
Drug
mycophenolate mofetil
Drug
allogeneic bone marrow transplantation
Procedure
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Hematopoietic recovery
Incidence of graft-versus-host disease
Secondary Outcomes
Measure
Description
Time Frame
Chemotherapeutic toxicity
Relapse and survival
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
1 Year
Maximum Age
80 Years
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
David G. Savage, MD
Herbert Irving Comprehensive Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Herbert Irving Comprehensive Cancer Center at Columbia University
New York
New York
10032
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
No data available
No data is available for this block.
peripheral blood stem cell transplantation
Procedure
syngeneic bone marrow transplantation
Procedure
ID
Term
D007938
Leukemia
D008223
Lymphoma
D009101
Multiple Myeloma
D054219
Neoplasms, Plasma Cell
D009190
Myelodysplastic Syndromes
D006689
Hodgkin Disease
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D016410
Lymphoma, T-Cell, Cutaneous
D015470
Leukemia, Myeloid, Acute
D015466
Leukemia, Myeloid, Chronic-Phase
D015465
Leukemia, Myeloid, Accelerated Phase
D001752
Blast Crisis
D015464
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D012008
Recurrence
D008224
Lymphoma, Follicular
D008228
Lymphoma, Non-Hodgkin
D016403
Lymphoma, Large B-Cell, Diffuse
D016400
Lymphoma, Large-Cell, Immunoblastic
D002051
Burkitt Lymphoma
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D064090
Intraocular Lymphoma
D054739
Dendritic Cell Sarcoma, Interdigitating
D020522
Lymphoma, Mantle-Cell
D007119
Immunoblastic Lymphadenopathy
D017728
Lymphoma, Large-Cell, Anaplastic
D009182
Mycosis Fungoides
D012751
Sezary Syndrome
D018442
Lymphoma, B-Cell, Marginal Zone
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D000013
Congenital Abnormalities
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D020141
Hemostatic Disorders
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D010265
Paraproteinemias
D001796
Blood Protein Disorders
D006474
Hemorrhagic Disorders
D001855
Bone Marrow Diseases
D007945
Leukemia, Lymphoid
D016399
Lymphoma, T-Cell
D007951
Leukemia, Myeloid
D009196
Myeloproliferative Disorders
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D002471
Cell Transformation, Neoplastic
D063646
Carcinogenesis
D009385
Neoplastic Processes
D016393
Lymphoma, B-Cell
D020031
Epstein-Barr Virus Infections
D006566
Herpesviridae Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D007239
Infections
D014412
Tumor Virus Infections
D005134
Eye Neoplasms
D009371
Neoplasms by Site
D015620
Histiocytic Disorders, Malignant
D015614
Histiocytosis
D000072281
Lymphadenopathy
D015448
Leukemia, B-Cell
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities