Trial · NCT00597714
Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant
NCT00597714, Phase 2, Completed, David Rizzieri, MD; results first posted 2014-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant. Trials, record NCT00597714. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00597714
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant
- NCT number
- NCT00597714
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 264 participants, actual
- Lead sponsor
- David Rizzieri, MD
- Conditions
- Hodgkin's Disease, Non Hodgkin's Lymphoma, Myeloma, Leukemia, Myelodysplasia
- Interventions
- Non-myeloablative Stem Cell Transplantation
- First posted
- 2008-01-18
- Last updated
- 2014-06-02
- Results first posted
- 2014-06-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival | 2 years | Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease relapse or death due to the disease. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants who were disease free at 2 years is reported by donor type. |
| Secondary | Immune Recovery | 1 year | 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. |
| Secondary | Progression Free Survival | 2 years | Progression-free survival (PFS) rates after stem cell transplant were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. PFS was defined as the period of time between the day of transplantation and either the day underlying disease progression was documented or death occurred by any cause. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants progression free at 2 years is reported by donor type. Progression = \> 25% increase of serum M-protein and/or urine M-protein. Also, an absolute increase in bone marrow plasma cells \> 10%, new bone lesions or soft tissue plasmacytomas or increase in the size of existing bone lesions or soft tissue plasmacytomas or development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder. |
| Secondary | Overall Survival | 2 years | Estimate overall survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. OS was defined as the period of time between the day of transplantation and death. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants surviving 2 years by donor type is reported. |
| Secondary | Graft Failure | 180 days | Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3-5 weeks after transplant to assess donor-cell engraftment. Primary Graft Failure was defined as a neutrophil count below 500/μL or the absence of donor-derived hematopoiesis (\<5%donor cells) before relapse, death, or re-transplantation. Secondary Graft Failure was defined as the achievement of primary engraftment and a subsequent decrease in neutrophils to 3 consecutive counts of less than 100/μL or the absence of donor-derived hematopoiesis (\<5% donor cells) before relapse, death, or re-transplantation. |
| Other | Graft Versus Host Disease | 180 days | Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3-5 weeks after transplant to assess donor-cell engraftment. Acute or chronic GVHD was diagnosed and graded according to standard criteria. Toxicity was formally graded using the National Cancer Institute Common Toxicity Criteria version 3.0. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival | 2 years | 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. DFS was analyzed by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical). | percentage of participants | NUMBER |
| SECONDARY | Immune Recovery | 1 year | 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). | T cells/μL | MEAN |
| SECONDARY | Progression Free Survival | 2 years | All participants who received transplant. 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). | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | 2 years | All participants who received transplant. 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). | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Graft Versus Host Disease | 180 days | All participants who received transplant. 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 occurrence of Graft versus Host Disease (GvHD) and Graft Failure and donor type. | percentage of participants | NUMBER |
| SECONDARY | Graft Failure | 180 days | All subjects who received transplant. 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 occurrence of Graft versus Host Disease (GvHD) and donor type. | number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival | Cohort A & B- Lymphoid & Myeloid Disease | Matched Related Donors (MRD); n=38 | 47 | 95% Confidence Interval 29 to 63 | percentage of participants |
| Disease Free Survival | Cohort A & B- Lymphoid & Myeloid Disease | Matched Unrelated Donors (MUD); n=53 | 23 | 95% Confidence Interval 12 to 36 | percentage of participants |
| Disease Free Survival | Cohort A & B- Lymphoid & Myeloid Disease | Haploidentical related (HAPLO) donors; n=33 | 16 | 95% Confidence Interval 5 to 33 | percentage of participants |
| Immune Recovery | Cohort A & B- Lymphoid & Myeloid Disease | Matched Related Donors (MRD) n=38 - CD3+ Tcells/uL | 700 | Standard Deviation 100 | T cells/μL |
| Immune Recovery | Cohort A & B- Lymphoid & Myeloid Disease | Matched Unrelated Donors(MUD) n=53 - CD3+Tcells/uL | 550 | Standard Deviation 150 | T cells/μL |
| Immune Recovery | Cohort A & B- Lymphoid & Myeloid Disease | Haploidentical related (HAPLO) n=33 -CD3+Tcells/uL | 500 | Standard Deviation 200 | T cells/μL |
| Immune Recovery | Cohort A & B- Lymphoid & Myeloid Disease | Matched Related Donors (MRD) n=38 - CD4+ Tcells/uL | 225 | Standard Deviation 30 | T cells/μL |
| Immune Recovery | Cohort A & B- Lymphoid & Myeloid Disease | Matched Unrelated Donors (MUD) n=53 -CD4+Tcells/uL | 140 | Standard Deviation 20 | T cells/μL |
| Immune Recovery | Cohort A & B- Lymphoid & Myeloid Disease | Haploidentical related (HAPLO) n=33 -CD4+Tcells/uL | 150 | Standard Deviation 55 | T cells/μL |
| Immune Recovery | Cohort A & B- Lymphoid & Myeloid Disease | Matched Related Donors (MRD) n=38 - CD8+ Tcells/uL | 420 | Standard Deviation 100 | T cells/μL |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A - Lymphoid Disease | 80 | |
| Overall Study | STARTED | Cohort B - Myeloid Disease | 57 | |
| Overall Study | STARTED | Donor | 94 | |
| Overall Study | COMPLETED | Cohort A - Lymphoid Disease | 24 | |
| Overall Study | COMPLETED | Cohort B - Myeloid Disease | 11 | |
| Overall Study | COMPLETED | Donor | 84 | |
| Overall Study | NOT COMPLETED | Cohort A - Lymphoid Disease | 56 | |
| Overall Study | NOT COMPLETED | Cohort B - Myeloid Disease | 46 | |
| Overall Study | NOT COMPLETED | Donor | 10 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Failure to Engraft | Blood and lymphatic system disorders | Cohort A - Lymphoid Disease | 3 | 80 | 3 |
| other | Failure to Engraft | Blood and lymphatic system disorders | Cohort B - Myeloid Disease | 13 | 57 | 13 |
| other | Diarrhea | Gastrointestinal disorders | Cohort A - Lymphoid Disease | 17 | 80 | 20 |
| other | Diarrhea | Gastrointestinal disorders | Cohort B - Myeloid Disease | 4 | 57 | 4 |
| other | Fever without neutropenia | General disorders | Cohort A - Lymphoid Disease | 4 | 80 | 7 |
| other | Fever without neutropenia | General disorders | Cohort B - Myeloid Disease | 0 | 57 | 0 |
| other | Rash/desquamation | Skin and subcutaneous tissue disorders | Cohort A - Lymphoid Disease | 2 | 80 | 2 |
| other | Rash/desquamation | Skin and subcutaneous tissue disorders | Cohort B - Myeloid Disease | 4 | 57 | 5 |
| other | Mucositis/Stomatitis | Gastrointestinal disorders | Cohort A - Lymphoid Disease | 5 | 80 | 5 |
| other | Mucositis/Stomatitis | Gastrointestinal disorders | Cohort B - Myeloid Disease | 2 | 57 | 2 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A - Lymphoid Disease | ||
| Total, all-cause mortality | Cohort B - Myeloid Disease | ||
| Total, other adverse events | Cohort A - Lymphoid Disease | 77 | 80 |
| Total, other adverse events | Cohort B - Myeloid Disease | 52 | 57 |
| Total, serious adverse events | Cohort A - Lymphoid Disease | 16 | 80 |
| Total, serious adverse events | Cohort B - Myeloid Disease | 10 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24269380 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cohort A - Lymphoid Disease vs Cohort B - Myeloid Disease: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT00597714/results?page=2