Trial · NCT00053989
NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders
NCT00053989, Phase 2, Completed, Roswell Park Cancer Institute; results first posted 2020-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders. Trials, record NCT00053989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00053989
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders
- NCT number
- NCT00053989
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Fanconi Anemia, Aplastic Anemia
- Interventions
anti-thymocyte globulin, graft-versus-tumor induction therapy, sargramostim, therapeutic allogeneic lymphocytes, cyclophosphamide, fludarabine phosphate, methylprednisolone, mycophenolate mofetil, tacrolimus, allogeneic bone marrow transplantation, peripheral blood stem cell transplantation, umbilical cord blood transplantation
- First posted
- 2003-02-06
- Last updated
- 2020-02-10
- Results first posted
- 2020-02-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Day 100 TRM | from start or conditioning (day -6 or -5) through day +100 after HSC infusion | treatment related mortality within 100 days from hematopoietic stem cell (HSC) infusion on day 0 |
| Primary | Day 100 Best Response | from start of conditioning on day -6 or -5 through day +100 after HSC infusion | Best disease response measured within 100 days from hematopoietic stem cell (HSC) infusion on day 0 using disease specific response criteria defined in the protocol |
| Secondary | PFS | 1 year | Progression free survival defined as time from HSC infusion (day 0) until progression of disease or death due to any cause. Patients are censored if alive without disease progression through 1 year after HSC infusion |
| Secondary | OS | 1 year | Overall survival with events defined as death due to any cause and censored patients are alive as of 1 year post HSC infusion |
| Secondary | Acute GvHD | Day +100 | overall grade II-IV acute GvHD |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Day 100 TRM | from start or conditioning (day -6 or -5) through day +100 after HSC infusion | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Day 100 Best Response | from start of conditioning on day -6 or -5 through day +100 after HSC infusion | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | PFS | 1 year | percentage of participants | NUMBER | |
| SECONDARY | OS | 1 year | percentage of participants | NUMBER | |
| SECONDARY | Acute GvHD | Day +100 | 2 participants died before they were eligible for this outcome | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Day 100 TRM | All Patients | 4 | Participants | ||
| Day 100 Best Response | All Patients | Complete Response | 22 | Participants | |
| Day 100 Best Response | All Patients | Partial Response | 5 | Participants | |
| Day 100 Best Response | All Patients | Early Death/NE | 4 | Participants | |
| Day 100 Best Response | All Patients | No Response/Stable Disease | 2 | Participants | |
| Day 100 Best Response | All Patients | Progressed | 8 | Participants | |
| PFS | All Patients | 27 | 95% Confidence Interval 13 to 40 | percentage of participants | |
| OS | All Patients | 44 | 95% Confidence Interval 29 to 59 | percentage of participants | |
| Acute GvHD | All Patients | 16 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Patients | 41 | |
| Overall Study | COMPLETED | All Patients | 41 | |
| Overall Study | NOT COMPLETED | All Patients | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | acute GVHD grade III-IV | Immune system disorders | All Patients | 6 | 41 | 6 |
| serious | DBE/FTE | Blood and lymphatic system disorders | All Patients | 3 | 41 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | 8 | 41 |
| Total, other adverse events | All Patients | 6 | 41 |
| Total, serious adverse events | All Patients | 3 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00053989
GET https://conductscience.org/api/trials/v1/NCT00053989/registered