Trial · NCT00472849
Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias
NCT00472849, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2013-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias. Trials, record NCT00472849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00472849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias
- NCT number
- NCT00472849
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Richter's Transformation, Leukemia
- Interventions
- Oxaliplatin, Fludarabine, Cytarabine, Rituximab, Pegfilgrastim
- First posted
- 2007-05-14
- Last updated
- 2013-11-26
- Results first posted
- 2013-11-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days) | Up to 36 weeks (6 cycles each 4-6 weeks) | Maximum dose levels for Phase I determined among three possible dose levels of Fludarabine and Cytarabine in combination with fixed doses of Oxaliplatin and Rituximab. Fludarabine and Cytarabine Dose Level 1: Days 2-3 (2 Days); Dose Level 2: Days 2-4 (3 Days); and Dose 3: Days 2-5 (4 Days). MTD is dose level at which less than 2/3 or 2/6 participants experience dose limiting toxicities (DLTs). The number of days of fludarabine and cytarabine administration increased simultaneously. Participants received a subsequent cycle of treatment with 1 additional day of fludarabine and cytarabine treatment no less than 4 weeks from the initiation of the previous cycle if no drug-related grade 3 or 4 non-hematologic life-threatening adverse events, and drug-related non-hematologic toxicity resolved to baseline or \< grade 2. A maximum of 6 cycles were administered. |
| Secondary | Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission | Up to 36 weeks (6 cycles each 4-6 weeks) | Overall Response includes Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) in high-risk, previously untreated participants with Chronic Lymphocytic Leukemia treated with CFAR using National Cancer Institute - Working Group response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)\>1,500/uL, Platelets \>100,000uL, Hemoglobin (untransfused) \>11.0g/dL, Lymphocytes \<4,000/uL and Bone Marrow Aspirate biopsy \<30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes \>/= 50% decrease,Liver/spleen \>/= 50% decrease, symptoms not applicable, PMN \>1,500/uL or \>50% improvement from baseline, Platelets 100,000uL or \>/=50% decrease improvement from baseline, Hemoglobin (untransfused) \>11.0g/dL or \>50% improvement from baseline, Lymphocytes \>50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with \<30% lymphocytes with residual disease on biopsy. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission | Up to 36 weeks (6 cycles each 4-6 weeks) | participants | NUMBER | |
| PRIMARY | Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days) | Up to 36 weeks (6 cycles each 4-6 weeks) | mg/m^2 | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission | OFAR MTD (Phase II) | Complete Remission | 3 | participants | |
| Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission | OFAR MTD (Phase II) | Partial Remission | 27 | participants | |
| Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission | OFAR MTD (Phase II) | Nodular Partial Remission | 9 | participants | |
| Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days) | OFAR (Phase I) | Fludarabine MTD (Total 3 Day Dose) | 90 | mg/m^2 | |
| Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days) | OFAR (Phase I) | Cytarabine MTD (Total 3 Day Dose) | 1500 | mg/m^2 |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OFAR (Phase I) | 12 | |
| Overall Study | STARTED | OFAR (Phase II) | 78 | |
| Overall Study | COMPLETED | OFAR (Phase I) | 12 | |
| Overall Study | COMPLETED | OFAR (Phase II) | 78 | |
| Overall Study | NOT COMPLETED | OFAR (Phase I) | 0 | |
| Overall Study | NOT COMPLETED | OFAR (Phase II) | 0 |
Source ClinicalTrials.gov
Adverse events86
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 | Constipation | Gastrointestinal disorders | OFAR (Phase I) | 2 | 12 | 2 |
| other | Constipation | Gastrointestinal disorders | OFAR MTD (Phase II) | 4 | 78 | 4 |
| other | Hiccups | Respiratory, thoracic and mediastinal disorders | OFAR (Phase I) | 1 | 12 | 1 |
| other | Hiccups | Respiratory, thoracic and mediastinal disorders | OFAR MTD (Phase II) | 4 | 78 | 4 |
| other | Edema | Blood and lymphatic system disorders | OFAR (Phase I) | 0 | 12 | 0 |
| other | Edema | Blood and lymphatic system disorders | OFAR MTD (Phase II) | 4 | 78 | 4 |
| other | Anorexia | Gastrointestinal disorders | OFAR (Phase I) | 2 | 12 | 2 |
| other | Anorexia | Gastrointestinal disorders | OFAR MTD (Phase II) | 4 | 78 | 4 |
| other | Pain | General disorders | OFAR (Phase I) | 1 | 12 | 1 |
| other | Pain | General disorders | OFAR MTD (Phase II) | 4 | 78 | 4 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OFAR (Phase I) | ||
| Total, all-cause mortality | OFAR MTD (Phase II) | ||
| Total, other adverse events | OFAR (Phase I) | 8 | 12 |
| Total, other adverse events | OFAR MTD (Phase II) | 71 | 78 |
| Total, serious adverse events | OFAR (Phase I) | 8 | 12 |
| Total, serious adverse events | OFAR MTD (Phase II) | 15 | 78 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| OFAR (Phase I) vs OFAR MTD (Phase II): serious adverse events |
Source Trial comparisons
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/NCT00472849
GET https://conductscience.org/api/trials/v1/NCT00472849/events?page=2