NCT00597714 · OUTCOME
Immune Recovery
Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant · Source last updated 2014-06-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- T cells/μL
- Interval / dispersion
- Standard Deviation
- Time frame
- 1 year
What was measured
Evaluate immune recovery following this reduced intensity allogeneic immunotherapy. Quantification of CD3+, CD4+, and CD8+ T cells was performed by flow cytometry on fresh peripheral blood at approximately 1 month before transplantation and then 1.5, 3, 6, and 12 months after transplantation. The immune recovery rates of the CD3+, CD4+, and CD8+ T cells in the MRD, MUD, and HAPLO groups were compared by performing an analysis of variance at each time point after transplantation. The median T cell counts at 12 months for each type of cell are reported by donor type.
Analysis population: All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).
Groups in this outcome
Cohort A & B- Lymphoid & Myeloid Disease
Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 124 |
|---|
Reported measurements
Matched Related Donors (MRD) n=38 - CD3+ Tcells/uL
Values in T cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 700 | 100 | Not reported | Not reported | Not reported |
|---|
Matched Unrelated Donors(MUD) n=53 - CD3+Tcells/uL
Values in T cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 550 | 150 | Not reported | Not reported | Not reported |
|---|
Haploidentical related (HAPLO) n=33 -CD3+Tcells/uL
Values in T cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 500 | 200 | Not reported | Not reported | Not reported |
|---|
Matched Related Donors (MRD) n=38 - CD4+ Tcells/uL
Values in T cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 225 | 30 | Not reported | Not reported | Not reported |
|---|
Matched Unrelated Donors (MUD) n=53 -CD4+Tcells/uL
Values in T cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 140 | 20 | Not reported | Not reported | Not reported |
|---|
Haploidentical related (HAPLO) n=33 -CD4+Tcells/uL
Values in T cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 150 | 55 | Not reported | Not reported | Not reported |
|---|
Matched Related Donors (MRD) n=38 - CD8+ Tcells/uL
Values in T cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 420 | 100 | Not reported | Not reported | Not reported |
|---|
Matched Unrelated Donors (MUD) n=53 -CD8+Tcells/uL
Values in T cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 350 | 150 | Not reported | Not reported | Not reported |
|---|
Haploidentical related (HAPLO) n=33 -CD8+Tcells/uL
Values in T cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A & B- Lymphoid & Myeloid Disease | 300 | 150 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 100
- value
- 700
- title
- Matched Related Donors (MRD) n=38 - CD3+ Tcells/uL
- categories
- measurements
- group Id
- OG000
- spread
- 150
- value
- 550
- title
- Matched Unrelated Donors(MUD) n=53 - CD3+Tcells/uL
- categories
- measurements
- group Id
- OG000
- spread
- 200
- value
- 500
- title
- Haploidentical related (HAPLO) n=33 -CD3+Tcells/uL
- categories
- measurements
- group Id
- OG000
- spread
- 30
- value
- 225
- title
- Matched Related Donors (MRD) n=38 - CD4+ Tcells/uL
- categories
- measurements
- group Id
- OG000
- spread
- 20
- value
- 140
- title
- Matched Unrelated Donors (MUD) n=53 -CD4+Tcells/uL
- categories
- measurements
- group Id
- OG000
- spread
- 55
- value
- 150
- title
- Haploidentical related (HAPLO) n=33 -CD4+Tcells/uL
- categories
- measurements
- group Id
- OG000
- spread
- 100
- value
- 420
- title
- Matched Related Donors (MRD) n=38 - CD8+ Tcells/uL
- categories
- measurements
- group Id
- OG000
- spread
- 150
- value
- 350
- title
- Matched Unrelated Donors (MUD) n=53 -CD8+Tcells/uL
- categories
- measurements
- group Id
- OG000
- spread
- 150
- value
- 300
- title
- Haploidentical related (HAPLO) n=33 -CD8+Tcells/uL
- description
- Evaluate immune recovery following this reduced intensity allogeneic immunotherapy. Quantification of CD3+, CD4+, and CD8+ T cells was performed by flow cytometry on fresh peripheral blood at approximately 1 month before transplantation and then 1.5, 3, 6, and 12 months after transplantation. The immune recovery rates of the CD3+, CD4+, and CD8+ T cells in the MRD, MUD, and HAPLO groups were compared by performing an analysis of variance at each time point after transplantation. The median T cell counts at 12 months for each type of cell are reported by donor type.
- dispersion Type
- Standard Deviation
- groups
- description
- Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
- id
- OG000
- title
- Cohort A & B- Lymphoid & Myeloid Disease
- param Type
- MEAN
- population Description
- All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Immune Recovery
- type
- SECONDARY
- unit Of Measure
- T cells/μL
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Preserved source evidence · Not medical advice
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