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| ID | Type | Description | Link |
|---|---|---|---|
| HR#19490 | Other Identifier | MUSC IRB |
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Study halted prematurely due to low accrual.
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This is study is for patients that have been diagnosed with high-risk hematological malignancies. The main purpose of this study is to confirm previously published results of stem cell transplantation with reduced intensity pre-transplant conditioning. Patients will be assigned to 1 of 3 regimens depending on the patient's diagnosis. Participants will be followed by the transplant team for the remainder of the patient's life. Patient's will visit MUSC daily, then visits will be reduced to frequent visits for up to 6 months. After 6 months, the visits will be reduced more depending on the patient's condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm, non-randomized study | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regimen A | Drug | Chronic Lymphocytic Leukemia/ Chronic Prolymphocytic Leukemia, Multiple Myeloma. |
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| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days. | Number of subject deaths prior to day 100. | 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants | To determine the engraftment rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens. It will be measured as the proportion of subjects meeting criteria for engraftment before day +30 and full donor chimerism demonstrated before or at day +100. Engraftment is defined by maintenance of ANC > 500/mm3 for at least 3 consecutive days and platelet count > 20,000/mm3 for 3 consecutive days in absence of platelet transfusion. These criteria must have been met before Day +30. Chimerism is the pressence of donor cells and will be analyzed by FISH for sex-mismatched donor-recipient pairs and VNTR analysis for sex-mathced pairs. Chimerism by Day +100 will be documented for this outcome |
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Inclusion Criteria:
Exclusion Criteria:
Donor Selection:
Inclusion Criteria
Exclusion Criterion
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| Name | Affiliation | Role |
|---|---|---|
| Robert Stuart, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Regimen A | Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma |
| FG001 | Group 2: Regimen B | Other Malignancies not addressed in regimens A and C |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Regimen B | Drug | Other malignancies not addressed in A or C |
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| Regimen C | Drug | B-Cell Lymphomas |
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| Day +100 |
| Morbidity of Allogeneic Stem Cell Transplants | To determine the morbidity, including the pattern and severity of complications, of allogeneic stem cell transplants using reduced-intensity conditioning regimens. The average number of days spent in the hospital until day +100 will be reported as a surrogate for morbidity and complications. | 100 days |
| FG002 | Group 3: Regimen C | B-Cell Lymphomas |
| COMPLETED |
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| NOT COMPLETED |
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Subjects who were enrolled to the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Regimen A | Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma |
| BG001 | Group 2: Regimen B | Other Malignancies not addressed in regimens A and C |
| BG002 | Group 3: Regimen C | B-Cell Lymphomas |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days. | Number of subject deaths prior to day 100. | For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures. | Posted | Number | participants | 8 years |
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| Secondary | To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants | To determine the engraftment rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens. It will be measured as the proportion of subjects meeting criteria for engraftment before day +30 and full donor chimerism demonstrated before or at day +100. Engraftment is defined by maintenance of ANC > 500/mm3 for at least 3 consecutive days and platelet count > 20,000/mm3 for 3 consecutive days in absence of platelet transfusion. These criteria must have been met before Day +30. Chimerism is the pressence of donor cells and will be analyzed by FISH for sex-mismatched donor-recipient pairs and VNTR analysis for sex-mathced pairs. Chimerism by Day +100 will be documented for this outcome | The outcome measure data below only accounts for the number of subjects who met the engraftment criteria prior at day +30; the chimerism data was not collected. For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures. | Posted | Number | participants | Day +100 |
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| Secondary | Morbidity of Allogeneic Stem Cell Transplants | To determine the morbidity, including the pattern and severity of complications, of allogeneic stem cell transplants using reduced-intensity conditioning regimens. The average number of days spent in the hospital until day +100 will be reported as a surrogate for morbidity and complications. | This study terminated early; funding ran out before the analysis could be completed. | Posted | 100 days |
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Start of treatment until end of study
repotable adverse events included:
any deaths occuring on study, any grade IV non-hematological toxicity until 1 year post transplant or 6 months after the last donor lymphocyte infusion (whichever is latest), severe (grade III or IV) acute graft versus host disease (GVHD) any unexpected adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Regimen A | Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma | 0 | 4 | 0 | 4 | ||
| EG001 | Group 2: Regimen B | Other Malignancies not addressed in regimens A and C | 32 | 67 | 0 | 67 | ||
| EG002 | Group 3: Regimen C | B-Cell Lymphomas | 0 | 7 | 0 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| altered mental status | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| GVHD | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
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| respiratory arrest | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| anoxic brain damage | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| TA-TMA | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| fever | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert K Stuart | Medical University of South Carolina | 843-792-4271 | stuartrk@musc.edu |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C103940 | OOS-A regimen |
| C072254 | Regimen B |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Group 3: Regimen C |
B-Cell Lymphomas |
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