Trial · NCT00043979
Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas
NCT00043979, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas. Trials, record NCT00043979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00043979
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas
- NCT number
- NCT00043979
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Sarcoma
- Interventions
F-18 Fluorodeoxyglucose, therapeutic allogeneic lymphocytes, cyclophosphamide, cyclosporine, doxorubicin hydrochloride, etoposide, fludarabine phosphate, melphalan, prednisone, sirolimus, tacrolimus, vincristine sulfate, peripheral blood stem cell transplantation, Filgrastim, Peripheral Blood Stem Cell donation
- First posted
- 2002-08-16
- Last updated
- 2017-05-31
- Results first posted
- 2013-09-13
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Engraftment | 100 days | Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, \>95% donor engraftment at day 100 in \>75% of patients. |
| Primary | Toxicity | 16.5 months | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. |
| Secondary | Number of Participants With Acute and Chronic GVHD | up to 5 years or death | Acute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100. |
| Secondary | Median Time to Reach Absolute Neutrophil Count of 500/mm(3) | up to 12 days | Days for participants to achieve a neutrophil count of 500/mm(3). |
| Secondary | Median Time to Reach a Platelet Count of 50,000/mm(3) | up to 43 days | Days for participants to achieve a platelet count of 50,000/mm(3). |
| Secondary | Early Post Transplantation Relapse | up to 300 days | Participants who experienced recurrence or progression of disease following transplant. |
| Secondary | Median Progression Free Survival | up to 77 months | Progression free survival was based on the time from on-study date until progression or last follow-up. |
| Secondary | Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant | 2 years | Participants who are alive at two years following Allo-Hematopoietic Stem Cell Transplant. |
| Secondary | Number of Participants to Complete Conversion to >95% Donor Chimerism | up to 30 days | Participants who tolerated the transplantation regimen and accepted \>95% of the donors blood, marrow, and/or tissue. |
| Secondary | Cluster of Differentiation 4 (CD4) Reconstitution | Day +28-42 | The median CD4 count with a range of 85-1565 (absolute count) was used to determine recovery and were considered recovered if in this range. The CD4 count was established by flow cytometry testing. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Engraftment | 100 days | E.g ...in \>75% of patients, shown above is not a conclusion but refers to a hypothesis, the objective of the protocol.~23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling. | Participants | NUMBER |
| PRIMARY | Toxicity | 16.5 months | Participants | NUMBER | |
| SECONDARY | Number of Participants With Acute and Chronic GVHD | up to 5 years or death | participants | NUMBER | |
| SECONDARY | Median Time to Reach Absolute Neutrophil Count of 500/mm(3) | up to 12 days | Days | MEDIAN | |
| SECONDARY | Median Time to Reach a Platelet Count of 50,000/mm(3) | up to 43 days | Days | MEDIAN | |
| SECONDARY | Early Post Transplantation Relapse | up to 300 days | One out of 23 participants did not have a recurrence, thus was excluded from analysis. | Days | MEDIAN |
| SECONDARY | Median Progression Free Survival | up to 77 months | 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling. | Months | MEDIAN |
| SECONDARY | Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant | 2 years | 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants to Complete Conversion to >95% Donor Chimerism | up to 30 days | 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cluster of Differentiation 4 (CD4) Reconstitution | Day +28-42 | mm(3) | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Engraftment | Arm 2-Recipients | 23 | Participants | ||
| Toxicity | Arm 2-Recipients | 30 | Participants | ||
| Number of Participants With Acute and Chronic GVHD | Recipients -Cyclosporine GVHD Prophylaxis | acute GVHD | 12 | participants | |
| Number of Participants With Acute and Chronic GVHD | Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis | acute GVHD | 5 | participants | |
| Number of Participants With Acute and Chronic GVHD | Recipients -Cyclosporine GVHD Prophylaxis | chronic GVHD | 12 | participants | |
| Number of Participants With Acute and Chronic GVHD | Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis | chronic GVHD | 5 | participants | |
| Median Time to Reach Absolute Neutrophil Count of 500/mm(3) | Arm 2-Recipients | 9 | Full Range 8 to 12 | Days | |
| Median Time to Reach a Platelet Count of 50,000/mm(3) | Arm 2-Recipients | 15 | Full Range 10 to 43 | Days | |
| Early Post Transplantation Relapse | Arm 2-Recipients | 100 | Full Range 28 to 300 | Days | |
| Median Progression Free Survival | Arm 2-Recipients | 15.9 | Full Range 2.2 to 77.0 | Months |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Sibling Donors | 30 | |
| Period 1 | STARTED | Recipients Cyclosporine GVHD Prophylaxis | 17 | |
| Period 1 | STARTED | Recipients Tacrolimus /Sirolimus Prophylaxis | 13 | |
| Period 1 | COMPLETED | Sibling Donors | 23 | |
| Period 1 | COMPLETED | Recipients Cyclosporine GVHD Prophylaxis | 13 | |
| Period 1 | COMPLETED | Recipients Tacrolimus /Sirolimus Prophylaxis | 10 | |
| Period 1 | NOT COMPLETED | Sibling Donors | 7 | |
| Period 1 | NOT COMPLETED | Recipients Cyclosporine GVHD Prophylaxis | 4 | |
| Period 1 | NOT COMPLETED | Recipients Tacrolimus /Sirolimus Prophylaxis | 3 | |
| Period 2 | STARTED | Sibling Donors | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events575
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 | Abdominal cramping | Gastrointestinal disorders | Arm 2-Recipients | 1 | 30 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | Arm 2-Recipients | 1 | 30 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Arm 2-Recipients | 1 | 30 | 1 |
| other | Abscesses (crypt) | Gastrointestinal disorders | Arm 2-Recipients | 1 | 30 | 1 |
| other | Acne breakout | Skin and subcutaneous tissue disorders | Arm 2-Recipients | 1 | 30 | 1 |
| other | Adenopathy | Blood and lymphatic system disorders | Arm 2-Recipients | 1 | 30 | 1 |
| other | Agitated mental status | Nervous system disorders | Arm 2-Recipients | 1 | 30 | 1 |
| other | Albumin low | Hepatobiliary disorders | Arm 2-Recipients | 1 | 30 | 1 |
| other | Alk. phosph. | Hepatobiliary disorders | Arm 2-Recipients | 1 | 30 | 1 |
| other | Allergic rhinitis-rhinorrhea | Immune system disorders | Arm 2-Recipients | 1 | 30 | 1 |
1 to 10 of 575Source ClinicalTrials.gov
See all 575 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 2-Recipients | 29 | 30 |
| Total, other adverse events | Arm 2-Recipients | 30 | 30 |
| Total, serious adverse events | Arm 2-Recipients | 29 | 30 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00043979
GET https://conductscience.org/api/trials/v1/NCT00043979/results?page=2