Trial · NCT00003838
Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow
NCT00003838, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2022-10-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow. Trials, record NCT00003838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003838
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow
- NCT number
- NCT00003838
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 202 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Myeloproliferative Disorders, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia
- Interventions
- T-cell replete PBPC allograft, Methotrexate, Cyclosporine, G-CSF
- First posted
- 2003-01-27
- Last updated
- 2023-09-21
- Results first posted
- 2022-10-07
- Limitations and caveats
- Group B: Stem Cell Transplant in Debilitating Hematologic Diseases was closed to enrollment in 2010.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced Transplant Related Mortality | 200 days | Number of Participants who experienced transplant related mortality by Day 200 |
| Secondary | Number of Participants With Complete Donor Myeloid (CD34+) and T-cell (CD3+) Chimerism | Up to Day 100 | Number of participants with complete donor myeloid chimerism. Myeloid (CD34+) and T-cell (CD3+) chimerisms were determined by PCR analysis of short tandem repeats (STR). Complete donor chimerism is defined as \>95% donor-derived cells in the peripheral blood in a specific lineage. |
| Secondary | Median Days to Neutrophil Engraftment | Day 30 | Median days to neutrophil recovery. Neutrophil recovery is defined as the first day of two consecutive days in which the ANC was 500 K/ml or greater unsupported by growth factors or granulocyte transfusion. |
| Secondary | Number of Participants Who Experienced Acute GVHD Grades II-IV | Up to Day 100 | Number of participants who experienced acute GVHD grades II-IV Acute-GVHD was graded and staged prospectively using criteria from the 1994 Consensus Conference on Acute-GVHD Grading. Grades are defined as: Grade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day. Grade III: Skin = Rash on \>50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea \> 1500 mL/day. Grade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin \>15 mg/dL; Lower GI = Severe abdominal pain with or without ileus. Grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. |
| Secondary | Number of Participant Who Experienced Chronic Graft Versus Host Disease Following Stem Cell Transplant | Day 100 up to 3 years | Number of participant who experienced chronic graft versus host disease (GVHD) following stem cell transplant The diagnosis of clinical features of chronic-GVHD was determined prospectively and classified retrospectively into limited or extensive based on the Revised Seattle Classification. Chronic GvHD severity categorized as "limited" is defined as: localized skin lesions with or without limited hepatic involvement and "extensive" is defined as: generalized skin involvement, major hepatic complications, or involvement of any other organ. |
| Secondary | Number of Participants Overall Survival | enrollment to date of death, up to 5 years | Number of participants overall survival. Overall survival is defined as number participants alive following stem cell transplant |
| Secondary | Number of Participants That Remained Disease-free Survival | Up to 5 years | Number of participants that remained Disease-free survival following stem cell transplant. Disease-free survival is defined as survival free of disease relapse or disease progression following stem cell transplant. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced Transplant Related Mortality | 200 days | The analyses included only those participants who had a transplant. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Donor Myeloid (CD34+) and T-cell (CD3+) Chimerism | Up to Day 100 | Alive participants who had a transplant with data available for analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Days to Neutrophil Engraftment | Day 30 | Alive participants who had a transplant with data available for analysis | Days | MEDIAN |
| SECONDARY | Number of Participants Who Experienced Acute GVHD Grades II-IV | Up to Day 100 | analysis performed as intention to treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participant Who Experienced Chronic Graft Versus Host Disease Following Stem Cell Transplant | Day 100 up to 3 years | The analyses included only those participants that engrafted and survived over 100 days | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Overall Survival | enrollment to date of death, up to 5 years | The analyses included only those participants that had a stem cell transplant | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Remained Disease-free Survival | Up to 5 years | The analyses included only those participants that had a stem cell transplant | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced Transplant Related Mortality | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 5 | Participants | ||
| Number of Participants Who Experienced Transplant Related Mortality | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 4 | Participants | ||
| Number of Participants With Complete Donor Myeloid (CD34+) and T-cell (CD3+) Chimerism | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | complete donor myeloid (CD34+) chimerism | 29 | Participants | |
| Number of Participants With Complete Donor Myeloid (CD34+) and T-cell (CD3+) Chimerism | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | complete donor myeloid (CD34+) chimerism | 55 | Participants | |
| Number of Participants With Complete Donor Myeloid (CD34+) and T-cell (CD3+) Chimerism | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | complete T-cell (CD3+) chimerism | 30 | Participants | |
| Number of Participants With Complete Donor Myeloid (CD34+) and T-cell (CD3+) Chimerism | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | complete T-cell (CD3+) chimerism | 56 | Participants | |
| Median Days to Neutrophil Engraftment | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 14 | Full Range 7 to 22 | Days | |
| Median Days to Neutrophil Engraftment | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 15 | Full Range 6 to 24 | Days | |
| Number of Participants Who Experienced Acute GVHD Grades II-IV | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | Grade II | 6 | Participants | |
| Number of Participants Who Experienced Acute GVHD Grades II-IV | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | Grade II | 16 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Donor | 102 | |
| Overall Study | STARTED | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 43 | |
| Overall Study | STARTED | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 57 | |
| Overall Study | COMPLETED | Donor | 102 | |
| Overall Study | COMPLETED | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 18 | |
| Overall Study | COMPLETED | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 49 | |
| Overall Study | NOT COMPLETED | Donor | 0 | |
| Overall Study | NOT COMPLETED | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 25 | |
| Overall Study | NOT COMPLETED | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 8 |
Source ClinicalTrials.gov
Adverse events393
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 |
|---|---|---|---|---|---|---|
| serious | Acute Gastrointestional Graft Verses Host Disease | Immune system disorders | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 8 | 43 | 8 |
| serious | Acute Gastrointestional Graft Verses Host Disease | Immune system disorders | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 9 | 57 | 14 |
| serious | Acute Gastrointestional Graft Verses Host Disease | Immune system disorders | Donor | 0 | 0 | 0 |
| serious | Acute Graft verses Host Disease of Skin | Immune system disorders | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 0 | 43 | 0 |
| serious | Acute Graft verses Host Disease of Skin | Immune system disorders | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 2 | 57 | 2 |
| serious | Acute Graft verses Host Disease of Skin | Immune system disorders | Donor | 0 | 101 | 0 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 2 | 43 | 2 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 0 | 57 | 0 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Donor | 0 | 101 | 0 |
| serious | Acute on Chronic Renal Failure | Renal and urinary disorders | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 1 | 43 | 1 |
1 to 10 of 393Source ClinicalTrials.gov
See all 393 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 26 | 43 |
| Total, all-cause mortality | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 9 | 57 |
| Total, all-cause mortality | Donor | 0 | 101 |
| Total, other adverse events | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 0 | 43 |
| Total, other adverse events | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 0 | 57 |
| Total, other adverse events | Donor | 0 | 101 |
| Total, serious adverse events | Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality | 41 | 43 |
| Total, serious adverse events | Group B: Stem Cell Transplant in Debilitating Hematologic Diseases | 47 | 57 |
| Total, serious adverse events | Donor | 1 | 101 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality vs Group B: Stem Cell Transplant in Debilitating Hematologic Diseases: Number of Participants That Remained Disease-free Survival | Trial comparisons |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality vs Group B: Stem Cell Transplant in Debilitating Hematologic Diseases: Number of Participants Who Experienced Transplant Related Mortality | Trial comparisons |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality vs Group B: Stem Cell Transplant in Debilitating Hematologic Diseases: Number of Participants Overall Survival | 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.
GET https://conductscience.org/api/trials/v1/NCT00003838
GET https://conductscience.org/api/trials/v1/NCT00003838/events?page=2