Trial · NCT00452374
Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL
NCT00452374, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2011-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL. Trials, record NCT00452374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00452374
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL
- NCT number
- NCT00452374
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- Cytarabine, Fludarabine, Oxaliplatin, Rituximab
- First posted
- 2007-03-27
- Last updated
- 2011-11-02
- Results first posted
- 2011-08-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) Oxaliplatin | From treatment onset to end of each cycle of treatment (every 21 days) | MTD defined as dose level at which 2/3 or 2/6 participants experience Dose Limiting Toxicity (DLT), where DLTs are any oxaliplatin-related ≥Grade 3 non-hematological toxicity involving a major organ system (brain, heart, kidney, liver, lung) in the National Cancer Institute (NCI) Version 3.0 toxicity scale. |
| Secondary | Number of Participants With a Complete Response or Partial Response | Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days | According to International Workshop Response Criteria for Non-Hodgkin's Lymphomas: Complete remission (CR) defined as \> 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; and Partial remission (PR) defined as \> 50% decrease of clinical symptoms from baseline and recovery from blood counts. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) Oxaliplatin | From treatment onset to end of each cycle of treatment (every 21 days) | Of the 48 study participants, 19 were enrolled in the Phase I MTD group and included in the MTD analysis. | mg/m^2 | NUMBER |
| SECONDARY | Number of Participants With a Complete Response or Partial Response | Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) Oxaliplatin | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 25 | mg/m^2 | ||
| Number of Participants With a Complete Response or Partial Response | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | Complete response (CR) | 12 | Participants | |
| Number of Participants With a Complete Response or Partial Response | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | Partial response (PR) | 28 | 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 | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 48 | |
| Overall Study | COMPLETED | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 48 | |
| Overall Study | NOT COMPLETED | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 0 |
Source ClinicalTrials.gov
Adverse events22
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 | Neutropenia | Blood and lymphatic system disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 48 | 48 | 48 |
| other | Anemia | Blood and lymphatic system disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 48 | 48 | 48 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 48 | 48 | 48 |
| other | Fatigue | General disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 20 | 48 | 20 |
| other | Nausea | Gastrointestinal disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 13 | 48 | 13 |
| other | Diarrhea | Gastrointestinal disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 8 | 48 | 8 |
| other | Constipation | Gastrointestinal disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 5 | 48 | 5 |
| other | Pain | General disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 5 | 48 | 5 |
| other | Anorexia | Gastrointestinal disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 3 | 48 | 3 |
| other | Mucositis | Gastrointestinal disorders | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 4 | 48 | 4 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | ||
| Total, other adverse events | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 48 | 48 |
| Total, serious adverse events | Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 28 | 48 |
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/NCT00452374
GET https://conductscience.org/api/trials/v1/NCT00452374/events?page=2