Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CHNY-01-501 | Other Identifier | CUMC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The sequential combination of myeloablative therapy and autologous stem cell transplantation (APBSCT) followed by a reduced intensity allogeneic stem cell transplant (Allo SCT) and post SCT adoptive cellular immunotherapy will be well tolerated in patients with refractory or recurrent non-Hodgkin's lymphoma (NHL) and Hodgkin's disease (HD).
Lymphomas are the third most common group of cancers in children and adolescents in the United States. While Hodgkin's Disease (HD) has been described for many years, some subtypes of the non-Hodgkin's Lymphomas (NHL) have only recently been described. Non-Hodgkin's lymphomas traditionally have been classified as low, intermediate or high grade based on their clinical aggressiveness. More recently they have been divided into two major subgroups indolent and aggressive lymphomas by the current National Cancer Institute (NCI/PDQ) reference. Among children, aggressive histologies are prevalent including small non-cleaved cell lymphoma, lymphoblastic lymphoma, and diffuse large cell lymphoma. The most common histologic classifications of childhood non-Hodgkin's lymphoma over the past 30 years has included the morphological schema developed by Rappaport, the morphologically and immunologically based schema of Lukes and Collins, the Kiel classifications, the prognostic sub-groupings of the National Cancer Institute's Working Formulation, and the most recently developed classification that utilizes morphological, immunophenotypic and genetic information in the Revised European-American Lymphoma (REAL) classification.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Family Donor | Experimental | Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant. The non-ablative therapy will be busulfan and fludarabine, Usually large (myeloablative) doses of these drugs are used for an allogeneic transplant. However, in this study lower doses (non-ablative) of chemotherapy will be given. In patients who still have evidence of disease after allogeneic transplant, additional donor immune cells (donor lymphocyte infusion) (DLI) will be given twice to further treat the lymphoma. |
|
| Arm B - Unrelated Cord Blood or Adult | Experimental | Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world. If a closely matched cord blood donor or unrelated adult donor is found, non-ablative chemotherapy with busulfan, fludarabine and antithymocyte globulin (ATG) followed by the infusion of matched unrelated cord blood cells or adult donor stem cells or bone marrow to restore the bone marrow will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | Fludarabine 30 mg/m2 x 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Subjects With a Complete Response (CR) Following Myeloablative Conditioning (MAC) and Autologous Stem Cell Transplantation (AutoSCT) | Complete Response is defined as the complete resolution of B symptoms (i.e., weight loss, night sweats and fever) and normalization of all sites of disease on the basis of physical exam, bone marrow biopsy, and imaging studies. | Up to 1 year post-transplantation |
| Total Number of Subjects With a Disease Relapse or Progression Following MAC AutoSCT | Includes subjects with any measurable growth of disease in a previously affected site or detection of disease in a new site confirmed by biopsy. | Up to 1 year post-transplantation |
| Total Number of Subjects With Partial Response or Stable Disease Following MAC AutoSCT | Total includes subjects with partial response and patients with stable disease, defined as <50% reduction in measurable disease or the uninterrupted persistence of B symptoms. | Up to 1 year post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Neutrophil Engraftment | Following MAC AutoSCT, the median time to neutrophil (PMN) recovery will be measured. | Up to 1 year post-transplantation |
| Time to Platelet Engraftment | Following MAC AutoSCT, the median time to platelet recovery will be measured. |
Not provided
Inclusion Criteria:
Patient must have adequate organ function as below
Adequate renal function defined as:
Adequate liver function defined as:
Adequate cardiac function defined as:
Adequate pulmonary function defined as:
Disease Status (Eligibility)
Patients with Non-Hodgkin's Lymphoma with either of the following:
Patients with Hodgkin's Disease with either of the following:
Primary induction failure (failure to achieve initial CR) and/or primary refractory disease.
First relapse
Patients must achieve a CR, PR or SD after reinduction chemotherapy.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prakash Satwani, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Memorial Hospital in Chicago | Chicago | Illinois | 60611 | United States | ||
| Hackensack University Medical Center |
Out of the 30 enrolled subjects, only 23 subjects received both MAC and AutoSCT and Reduced Intensity Conditioning (RIC) and allogeneic hematopoietic cell transplantation (AlloHCT). 7 subjects did not complete the transplantation and therefore were not included into data analysis.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A - Family Donor | Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant. |
| FG001 | Arm B - Unrelated Cord Blood or Adult | Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A - Family Donor | Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant. |
| BG001 | Arm B - Unrelated Cord Blood or Adult |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Total Number of Subjects With a Complete Response (CR) Following Myeloablative Conditioning (MAC) and Autologous Stem Cell Transplantation (AutoSCT) | Complete Response is defined as the complete resolution of B symptoms (i.e., weight loss, night sweats and fever) and normalization of all sites of disease on the basis of physical exam, bone marrow biopsy, and imaging studies. | Posted | Count of Participants | Participants | Up to 1 year post-transplantation |
|
Not provided
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 | Arm A - Family Donor | Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prakash Satwani, MD | Columbia University | (212) 305-0223 | ps2087@cumc.columbia.edu |
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D002066 | Busulfan |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Busulfan | Drug | Busulfan 3.2 mg/kg/day x 2 days |
|
|
| Anti-Thymocyte Globulin | Drug | Anti-Thymocyte Globulin 2.0 mg/kg/day x 4 days |
|
|
| Up to 1 year post-transplantation |
| Total Number of Subjects With Grade II-IV Acute Graft-versus-Host-Disease (GVHD) | The criteria for grading is based on extent of organ involvement (i.e., Skin, Liver and Gut - rash on >50% of skin, bilirubin 2-3 mg/dl, diarrhea > 500 ml/day) with Grade II being better outcome and Grade IV being worse outcome. | Up to 1 year post-transplantation |
| Total Number of Subjects That Experienced Transplant-related Mortality (TRM) | Status as subjects died post-AlloHCT | Up to 1 year post-transplantation |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world. |
|
|
| Primary | Total Number of Subjects With a Disease Relapse or Progression Following MAC AutoSCT | Includes subjects with any measurable growth of disease in a previously affected site or detection of disease in a new site confirmed by biopsy. | Posted | Count of Participants | Participants | Up to 1 year post-transplantation |
|
|
|
| Primary | Total Number of Subjects With Partial Response or Stable Disease Following MAC AutoSCT | Total includes subjects with partial response and patients with stable disease, defined as <50% reduction in measurable disease or the uninterrupted persistence of B symptoms. | Posted | Count of Participants | Participants | Up to 1 year post-transplantation |
|
|
|
| Secondary | Time to Neutrophil Engraftment | Following MAC AutoSCT, the median time to neutrophil (PMN) recovery will be measured. | Posted | Mean | Full Range | days | Up to 1 year post-transplantation |
|
|
|
| Secondary | Time to Platelet Engraftment | Following MAC AutoSCT, the median time to platelet recovery will be measured. | 1 subject under Arm A and 2 subject under Arm B did not have this data point collected and therefore 3 subjects were not included into analysis. | Posted | Mean | Full Range | days | Up to 1 year post-transplantation |
|
|
|
| Secondary | Total Number of Subjects With Grade II-IV Acute Graft-versus-Host-Disease (GVHD) | The criteria for grading is based on extent of organ involvement (i.e., Skin, Liver and Gut - rash on >50% of skin, bilirubin 2-3 mg/dl, diarrhea > 500 ml/day) with Grade II being better outcome and Grade IV being worse outcome. | Subjects who completed RIC AlloHCT | Posted | Number | participants | Up to 1 year post-transplantation |
|
|
|
| Secondary | Total Number of Subjects That Experienced Transplant-related Mortality (TRM) | Status as subjects died post-AlloHCT | Posted | Number | participants | Up to 1 year post-transplantation |
|
|
|
| 2 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Arm B - Unrelated Cord Blood or Adult | Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world. | 6 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |