Trial · NCT00920972
Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
NCT00920972, Phase 1, Phase 2, Recruiting, Washington University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases. Trials, record NCT00920972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00920972
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
- NCT number
- NCT00920972
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 220 participants, estimated
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Metabolic Disorders, Hematologic, Immune, or Bone Marrow Disorders, Hemoglobinopathies, Non-malignant Disorders
- Interventions
- Treatment Plan 1: Stratum 1, Treatment Plan 2: Strata 2, 3, or 4, GVHD Regimen A: UCB Recipients, GVHD Regimen B: BM Recipients
- First posted
- 2009-06-16
- Last updated
- 2026-09-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Donor engraftment as measured by chimerism | 100 days post-transplant | Engraftment is measured in myeloid and lymphoid lineage cells |
| Primary | Major toxicities as graded by the CTC v4 | 100 days post-transplant | Toxicity monitoring includes unanticipated side effects (new) and all severe irreversible toxicities Grade 3 and above unexpected Grade 4 and above - all toxicities that are possibly, probably or definitely related to protocol therapy All deaths irrespective of attribution |
| Secondary | Time to neutrophil and platelet engraftment as measured by complete blood counts | Post transplant | Defined as an ANC \>500/microliter and platelets \>20,000 or 50,000/microliter depending on disorder |
| Secondary | Incidence of acute graft-versus-host disease as measured by protocol grading scale | 100 days post-transplant | aGVHD - involving the skin, gut and liver. Classified according to grading described by Thomas et al. NEJM 1975; 292:895-902 |
| Secondary | Incidence of chronic graft-versus-host disease as measured by protocol grading scale | 2 years post-transplant | cGVHD classified per Schulman et al. Am J Med 69: 204-17, 1980. |
| Secondary | Long-term donor engraftment by donor chimerism | 2 years post-transplant | Donor chimerism is determined by PCR analysis after cell separation into lymphoid and myeloid lineage cells using antibodies. Can also be detected by FISH analysis in the event of donor and recipient sex discrepancy. |
| Secondary | Immune reconstitution by laboratory evaluations | 1 year post-transplant | Immune reconstitution detected by absolute numbers of T cell phenotypes, B cells and NK cells. T cell function determined by proliferative response to mitogens. B cell function determined by evaluating anti-tetanus antibody titers. |
| Secondary | Overall and disease free survival | 2 years post-transplant | Overall survival is defined as survival with or without disease Event free survival is defined as disease free, severe GVHD free survival, monitoring quality of life and relevant parameters. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
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/NCT00920972
GET https://conductscience.org/api/trials/v1/NCT00920972/registered