Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CHNY-01-511 | Other Identifier | CU |
Not provided
Not provided
Not provided
inactive
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.
This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory SLE or SSc.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Intensity Regimen for Refractory SLE | Experimental | RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE). |
|
| Reduced Intensity Regimen for SSc | Experimental | RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced Intensity Allogeneic Transplant | Procedure | Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc). |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Toxicity associated with reduced intensity regimen of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory Systemic Lupus Erythematosus (SLE) or SSc is measured. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Chimerism | Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points. | 1 year |
| Immune Reconstitution. | Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mitchell Cairo, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
Not provided
| Label | URL |
|---|---|
| (Click on "Morgan Stanley Children's Hospital" and then "Clinical Services" and then "Blood \& Marrow Transplantation") | View source |
Not provided
Not provided
Study closed due to low accrual.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Intensity Regimen SSc | Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fludarabine | Drug | Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2 |
|
| Busulfan | Drug | Busulfan 3.2 mg/kg Days _8, -7, -6, -5 |
|
| Campath | Drug | Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2 |
|
|
| 1 year |
| Progression Free and Overall Survival. | Probability of progression free and overall survival will be measured. | 1 year |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Systemic Sclerosis (SSc) | Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Subjects 7-17yrs will be enrolled | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Toxicity | Toxicity associated with reduced intensity regimen of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory Systemic Lupus Erythematosus (SLE) or SSc is measured. | Posted | 1 year |
|
| |||||||||||||||||||||||
| Secondary | Chimerism | Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points. | Not Posted | Number | Standard Deviation | participants | 1 year | ||||||||||||||||||||||
| Secondary | Immune Reconstitution. | Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell. | Not Posted | Number | Standard Deviation | participants | 1 year | ||||||||||||||||||||||
| Secondary | Progression Free and Overall Survival. | Probability of progression free and overall survival will be measured. | Not Posted | Number | Standard Deviation | participants | 1 year |
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced Intensity Regimen SSc | Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc) | 0 | 1 | 0 | 1 |
Not provided
Not provided
Study closed due to low accrual. Did not meet enrollment goals.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mitchell S. Cairo | New York Medical College | 914-594-3650 | mitchell_cairo@nymc.edu |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D012595 | Scleroderma, Systemic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C024352 | fludarabine |
| D002066 | Busulfan |
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided