Trial · NCT00867529
Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma
NCT00867529, Phase 2, Completed, Fred Hutchinson Cancer Center; results first posted 2017-05-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma. Trials, record NCT00867529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00867529
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma
- NCT number
- NCT00867529
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
B-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Post-transplant Lymphoproliferative Disorder, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Testicular Lymphoma, Waldenström Macroglobulinemia
- Interventions
- rituximab, peripheral blood stem cell transplantation, nonmyeloablative allogeneic hematopoietic stem cell transplantation, pharmacological study, laboratory biomarker analysis
- First posted
- 2009-03-23
- Last updated
- 2018-01-02
- Results first posted
- 2017-05-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Relapse Rate | At 18 months | Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated. |
| Secondary | Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 | Through day +100 after transplant | Number of patients who developed acute/chronic GVHD post-transplant. A chronic GVHD diagnosis ≥1 manifestation that is distinctive for chronic GVHD, as opposed to acute GVHD. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death |
| Secondary | Overall Survival and Progression-free Survival | At 6 months and then every year thereafter, up to 18 months | Number of patients surviving and number of patients surviving without progressive/relapsed disease, post-transplant. |
| Secondary | Rate of Graft Rejection and Graft Failure | 18 Months | Number of patients experiencing graft rejection and/or graft failure |
| Secondary | Time to Engraftment | 18 Months | Median time from transplant to engraftment. |
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 | Disease Relapse Rate | At 18 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 | Through day +100 after transplant | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival and Progression-free Survival | At 6 months and then every year thereafter, up to 18 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Graft Rejection and Graft Failure | 18 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Engraftment | 18 Months | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Relapse Rate | Treatment (Rituximab Pre- and Post-transplant) | 18 | Participants | ||
| Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 | Treatment (Rituximab Pre- and Post-transplant) | 17 | Participants | ||
| Overall Survival and Progression-free Survival | Treatment (Rituximab Pre- and Post-transplant) | PFS - 6 Months | 48 | Participants | |
| Overall Survival and Progression-free Survival | Treatment (Rituximab Pre- and Post-transplant) | PFS - 1 Year | 39 | Participants | |
| Overall Survival and Progression-free Survival | Treatment (Rituximab Pre- and Post-transplant) | PFS - 1.5 Years | 34 | Participants | |
| Overall Survival and Progression-free Survival | Treatment (Rituximab Pre- and Post-transplant) | OS - 6 Months | 52 | Participants | |
| Overall Survival and Progression-free Survival | Treatment (Rituximab Pre- and Post-transplant) | OS - 1 Year | 44 | Participants | |
| Overall Survival and Progression-free Survival | Treatment (Rituximab Pre- and Post-transplant) | OS - 1.5 Years | 36 | Participants | |
| Rate of Graft Rejection and Graft Failure | Treatment (Rituximab Pre- and Post-transplant) | Graft Rejection | 1 | Participants | |
| Rate of Graft Rejection and Graft Failure | Treatment (Rituximab Pre- and Post-transplant) | Graft Failure | 0 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Rituximab Pre- and Post-transplant) | 63 | |
| Overall Study | COMPLETED | Treatment (Rituximab Pre- and Post-transplant) | 63 | |
| Overall Study | NOT COMPLETED | Treatment (Rituximab Pre- and Post-transplant) | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | ARDS | Respiratory, thoracic and mediastinal disorders | Treatment (Rituximab Pre- and Post-transplant) | 3 | 63 | 3 |
| other | Diffuse Alveolar Hemorrhage | Respiratory, thoracic and mediastinal disorders | Treatment (Rituximab Pre- and Post-transplant) | 3 | 63 | 3 |
| other | Hypoxia | Respiratory, thoracic and mediastinal disorders | Treatment (Rituximab Pre- and Post-transplant) | 11 | 63 | 12 |
| other | Elevated Bilirubin | Hepatobiliary disorders | Treatment (Rituximab Pre- and Post-transplant) | 4 | 63 | 4 |
| other | Elevated Creatinine | Renal and urinary disorders | Treatment (Rituximab Pre- and Post-transplant) | 5 | 63 | 5 |
| serious | Multiple Pulmonary Emboli | Respiratory, thoracic and mediastinal disorders | Treatment (Rituximab Pre- and Post-transplant) | 1 | 63 | 1 |
| serious | Suspected Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Treatment (Rituximab Pre- and Post-transplant) | 1 | 63 | 1 |
| serious | Death Due to Infection | Infections and infestations | Treatment (Rituximab Pre- and Post-transplant) | 2 | 63 | 2 |
| serious | Sepsis and Tachycardia | Infections and infestations | Treatment (Rituximab Pre- and Post-transplant) | 1 | 63 | 1 |
| serious | Sepsis, Respiratory Failure, Mental Status Change | Infections and infestations | Treatment (Rituximab Pre- and Post-transplant) | 1 | 63 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Rituximab Pre- and Post-transplant) | ||
| Total, other adverse events | Treatment (Rituximab Pre- and Post-transplant) | 15 | 63 |
| Total, serious adverse events | Treatment (Rituximab Pre- and Post-transplant) | 5 | 63 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31481800 | DERIVED |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P01CA078902 | Preventing Relapse After Non-myeloablative Stem Cell Transplantation: The Final Challenge | SANDMAIER, BRENDA MARIE; WALTER, ROLAND BRUNO | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1999 to 2025 | NIH RePORTER |
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
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/NCT00867529
GET https://conductscience.org/api/trials/v1/NCT00867529/registered