Trial · NCT00043979
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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. |
| Secondary | Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin) | up to 10 cycles of therapy or 280 days | Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). RECIST criteria offer a simplified, conservative, extraction of imaging data for wide application in clinical trials. They presume that linear measures are an adequate substitute for 2-D (dimensional) methods and registers four response categories: Complete response (CR) is disappearance of all target lesions. Partial response (PR) is 30% increase in the sum of the longest diameter of target lesions. Progressive disease (PD) is 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is small changes that do not meet above criteria. For the purposes of this study very good partial response ((VGPR) is \>75% reduction in disease) was also employed. |
| Secondary | Median Survival From Date of Progression | up to 77 months | Median survival from date of progression is based on the time from on-study date until progression or last follow-up. |
| Other | Number of Participants Who Experienced Graft Versus Tumor Effect (GVT) | up to day 100 | GVT is defined as tumor response after day 42 post-transplantation without cytotoxic therapy. |
| Other | Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy | up to 6 cycles or 168 days | Site of radiotherapy (high energy radiation) and/or toxicity experienced by the participants post HSCT radiotherapy. Grading was preformed using the Modified Glucksberg Criteria. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT00043979/registered