Trial · NCT00946023
Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab
NCT00946023, Phase 2, Terminated, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2018-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab. Trials, record NCT00946023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00946023
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab
- NCT number
- NCT00946023
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 135 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Lymphoma, B-cell Lymphoma, Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- Interventions
- Fludarabine, Cyclophosphamide, Total body irradiation, Tacrolimus, Mycophenolate Mofetil, Rituximab, Allogeneic Bone Marrow Transplant (BMT)
- First posted
- 2009-07-24
- Last updated
- 2018-08-27
- Results first posted
- 2018-07-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | 1 year post-intervention | Percentage of participants alive and without relapse or disease progression. |
| Secondary | Progression-free Survival | 2 years post-intervention | Percentage of participants alive with and without relapse. |
| Secondary | Overall Survival | 1 year post intervention | Percentage of participants alive. |
| Secondary | Overall Survival | 2 years post intervention | Percentage of participants alive. |
| Secondary | Relapse | 1 year post intervention | Percentage of participants alive with relapse or disease progression. |
| Secondary | Relapse | 2 years post intervention | Percentage of participants alive with relapse or disease progression. |
| Secondary | Non-relapse Mortality | 1 year post intervention | Percentage of participants who died due to BMT-related reasons. |
| Secondary | Incidence of Grades II-IV Acute Graft-versus-Host-Disease (GVHD) | 1 year post intervention | Percentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria. |
| Secondary | Incidence of Grades III-IV Acute GVHD | 1 year post intervention | Percentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria. |
| Secondary | Incidence of Chronic GVHD | 1 year post intervention | Percentage of participants who experienced chronic GVHD. Chronic GVHD is graded using NIH consensus criteria and Seattle criteria. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | 1 year post-intervention | Populations were analyzed as follows:~1. All participants~2. Recipients of haploidentical donors (69 participants)~3. Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants) | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | 2 years post-intervention | Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants) | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | 1 year post intervention | Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants) | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | 2 years post intervention | Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants) | percentage of participants | NUMBER |
| SECONDARY | Relapse | 1 year post intervention | Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants) | percentage of participants | NUMBER |
| SECONDARY | Relapse | 2 years post intervention | Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants) | percentage of participants | NUMBER |
| SECONDARY | Non-relapse Mortality | 1 year post intervention | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Grades II-IV Acute Graft-versus-Host-Disease (GVHD) | 1 year post intervention | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Grades III-IV Acute GVHD | 1 year post intervention | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Chronic GVHD | 1 year post intervention | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Transplant | All participants | 71 | 95% Confidence Interval 62 to 82 | percentage of participants |
| Progression-free Survival | Transplant | Haploidentical recipients | 70 | 95% Confidence Interval 61 to 81 | percentage of participants |
| Progression-free Survival | Transplant | VV donor | 82 | 95% Confidence Interval 66 to 100 | percentage of participants |
| Progression-free Survival | Transplant | VF donor | 70 | 95% Confidence Interval 56 to 85 | percentage of participants |
| Progression-free Survival | Transplant | FF donor | 65 | 95% Confidence Interval 44 to 88 | percentage of participants |
| Progression-free Survival | Transplant | All participants | 60 | 95% Confidence Interval 52 to 70 | percentage of participants |
| Progression-free Survival | Transplant | Haploidentical recipients | 63 | 95% Confidence Interval 52 to 76 | percentage of participants |
| Progression-free Survival | Transplant | VV donor | 68 | 95% Confidence Interval 48 to 96 | percentage of participants |
| Progression-free Survival | Transplant | VF donor | 59 | 95% Confidence Interval 46 to 76 | percentage of participants |
| Progression-free Survival | Transplant | FF donor | 56 | 95% Confidence Interval 39 to 81 | percentage of participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Transplant | 83 | |
| Overall Study | COMPLETED | Transplant | 83 | |
| Overall Study | NOT COMPLETED | Transplant | 0 |
Source ClinicalTrials.gov
Adverse events51
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 | Fever | General disorders | Transplant | 5 | 83 | 5 |
| other | Infection | Infections and infestations | Transplant | 46 | 83 | 86 |
| other | Neutropenic fever | Infections and infestations | Transplant | 11 | 83 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | Transplant | 5 | 83 | 7 |
| other | Rash | Skin and subcutaneous tissue disorders | Transplant | 33 | 83 | 43 |
| other | Sinusitis | Respiratory, thoracic and mediastinal disorders | Transplant | 5 | 83 | 5 |
| serious | Allergic reaction | Immune system disorders | Transplant | 3 | 83 | 3 |
| serious | Neutropenia | Blood and lymphatic system disorders | Transplant | 4 | 83 | 4 |
| serious | Pancytopenia | Blood and lymphatic system disorders | Transplant | 1 | 83 | 1 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Transplant | 3 | 83 | 3 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Transplant | 34 | 83 |
| Total, other adverse events | Transplant | 62 | 83 |
| Total, serious adverse events | Transplant | 56 | 83 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26183076 | RESULT |
Source PubMed
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/NCT00946023
GET https://conductscience.org/api/trials/v1/NCT00946023/results?page=2