Trial · NCT00329030
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | 1 and 2 years | Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (\> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first. |
| Secondary | Overall Survival | 1 and 2 years | The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation |
| Secondary | Incidence of Relapse/Progression | 1 and 2 years | The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up. |
| Secondary | Complete Response (CR) and Partial Response (PR) Proportion | Day 100 and 2 years | |
| Secondary | Platelet Recovery to 20,000 Cells/μL | 100 and 180 days | |
| Secondary | Hematologic Function | 100 days, 1 year | Hematologic function will be defined as ANC \> 1,500 neutrophils/μL, hemoglobin \> 10 g/dL without transfusion support, and platelet count \> 100,000/μL without transfusion support. |
| Secondary | Incidence of Infection | 1 year | |
| Secondary | Mucositis Severity | Day 21 | Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa. |
| Secondary | Immune Reconstitution | 1 year | Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-. |
| Secondary | Immune Reconstitution of Quantitative Immunoglobulins | 1 year | Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA. |
| Secondary | Treatment-related Mortality (TRM) | 1 and 2 years | TRM is defined as death occurring in a patient from causes other than relapse or progression |
| Secondary | Neutrophil Recovery | Day 28 and Day 60 | Time to neutrophil recovery will be the first of two consecutive days of \> 500 neutrophils/μL following the expected nadir. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00329030/registered