Trial · NCT00003910
Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
NCT00003910, Phase 2, Terminated, Eastern Cooperative Oncology Group; results first posted 2013-05-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia. Trials, record NCT00003910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003910
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
- NCT number
- NCT00003910
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- Eastern Cooperative Oncology Group
- Conditions
- Leukemia
- Interventions
- Cyclophosphamide, Methotrexate, Prednisone
- First posted
- 2003-01-27
- Last updated
- 2023-07-05
- Results first posted
- 2013-05-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Complete or Partial Response to Treatment With MTX | Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date. | We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count \> 1500/mm3, lymphocyte count\< 4000/mm3, hemoglobin \> 11 g/dl, and platelet count \> 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement. |
| Secondary | Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX | Assessed during the first 4 months of treatment and followed until reaching full study stop date | We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count \> 1500/mm3, lymphocyte count\< 4000/mm3, hemoglobin \> 11 g/dl, and platelet count \> 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement. |
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 | Proportion of Patients With Complete or Partial Response to Treatment With MTX | Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date. | Of the 59 pts, 4 were ineligible and excluded from the analysis. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX | Assessed during the first 4 months of treatment and followed until reaching full study stop date | Eligible patients who received Cy after failing to respond to MTX are included in this analysis. | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Complete or Partial Response to Treatment With MTX | Methotrexate | 0.39 | 95% Confidence Interval 0.26 to 0.53 | proportion of participants | |
| Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX | Cyclophosphamide (Cy) | 0.64 | 95% Confidence Interval 0.35 to 0.87 | proportion of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Step 1 | STARTED | Methotrexate | 55 | |
| Step 1 | STARTED | Cyclophosphomide | 0 | |
| Step 1 | COMPLETED | Methotrexate | 55 | |
| Step 1 | COMPLETED | Cyclophosphomide | 0 | |
| Step 1 | NOT COMPLETED | Methotrexate | 0 | |
| Step 1 | NOT COMPLETED | Cyclophosphomide | 0 | |
| Step 2 | STARTED | Methotrexate | 0 | |
| Step 2 | STARTED | Cyclophosphomide | 16 | |
| Step 2 | COMPLETED | Methotrexate | 0 | |
| Step 2 | COMPLETED | Cyclophosphomide | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events110
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 | AST increased | Metabolism and nutrition disorders | Methotrexate | 21 | 59 | |
| other | AST increased | Metabolism and nutrition disorders | Cyclophosphamide | 0 | 16 | |
| other | Alkaline Phosphatase Increased | Metabolism and nutrition disorders | Methotrexate | 9 | 59 | |
| other | Alkaline Phosphatase Increased | Metabolism and nutrition disorders | Cyclophosphamide | 0 | 16 | |
| other | Anemia | Blood and lymphatic system disorders | Methotrexate | 41 | 59 | |
| other | Anemia | Blood and lymphatic system disorders | Cyclophosphamide | 5 | 16 | |
| other | Anorexia | Metabolism and nutrition disorders | Methotrexate | 11 | 59 | |
| other | Anorexia | Metabolism and nutrition disorders | Cyclophosphamide | 0 | 16 | |
| other | Bilirubin Increased | Metabolism and nutrition disorders | Methotrexate | 15 | 59 | |
| other | Bilirubin Increased | Metabolism and nutrition disorders | Cyclophosphamide | 0 | 16 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methotrexate | ||
| Total, all-cause mortality | Cyclophosphamide | ||
| Total, other adverse events | Methotrexate | 56 | 59 |
| Total, other adverse events | Cyclophosphamide | 6 | 16 |
| Total, serious adverse events | Methotrexate | 56 | 59 |
| Total, serious adverse events | Cyclophosphamide | 8 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Methotrexate vs Cyclophosphamide: 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/NCT00003910
GET https://conductscience.org/api/trials/v1/NCT00003910/events?page=2