Trial · NCT00671658
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
NCT00671658, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-12-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia. Trials, record NCT00671658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00671658
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
- NCT number
- NCT00671658
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 220 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia, Acute Lymphoblastic Leukemia
- Interventions
- Rituximab, Cyclophosphamide (CTX), Doxorubicin, Vincristine, Dexamethasone, Methotrexate (MTX), Cytarabine, G-CSF, Mesna, Pegylated asparaginase, Pegfilgrastim, Solumedrol
- First posted
- 2008-05-05
- Last updated
- 2020-12-03
- Results first posted
- 2020-12-03
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response | Response assessed following first 21 day course up to end of treatment with 8 cycles, up to 210 days | Response - Complete remission (CR): Normalization peripheral blood \& bone marrow 5% or \<blasts in normocellular or hypercellular marrow granulocyte count of 1x10\^9/L or \> \& platelet count \>100x10\^9/L; CR with incomplete platelet recovery (CRp): CR but platelet count \<100x10\^9/L. CR with incomplete recovery (CRi): CR but platelet count \<100x10\^9/L or absolute neutrophil count \< 1x10\^9/L. Partial response (PR): As above except for presence of 6-25% marrow blasts. Lymphoblastic lymphoma (\& ALL subtypes with extramedullary disease): CR - disappearance all known disease. PR - \>50% decrease in tumor size using sum of product, includes 50% volume decrease in lesions measurable in 3 dimensions. No Response (NR) - No significant change (includes stable disease). Lesions decreased size but \<50% or lesions with slight enlargement \<25% increase in size. Progressive Disease (PD): Appearance new lesions, 25% or \> increase in size existing lesions (\>50% if 1 lesion \& \<2). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Response | Response assessed following first 21 day course up to end of treatment with 8 cycles, up to 210 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 |
|---|---|---|---|---|---|
| Number of Participants With a Response | HYPER-CVAD | Complete Response (CR) | 198 | Participants | |
| Number of Participants With a Response | HYPER-CVAD | Complete Response without Platelet Recovery | 3 | Participants | |
| Number of Participants With a Response | HYPER-CVAD | Partial Response (PR) | 4 | 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 | HYPER-CVAD | 220 | |
| Overall Study | COMPLETED | HYPER-CVAD | 215 | |
| Overall Study | NOT COMPLETED | HYPER-CVAD | 5 |
Source ClinicalTrials.gov
Adverse events64
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 | Diarrhea | Gastrointestinal disorders | HYPER-CVAD | 10 | 220 | 10 |
| other | Neutropenic Fever | Infections and infestations | HYPER-CVAD | 24 | 220 | 24 |
| other | Infection | Infections and infestations | HYPER-CVAD | 20 | 220 | 20 |
| other | Neutropenia | Blood and lymphatic system disorders | HYPER-CVAD | 12 | 220 | 12 |
| serious | Vision Loss | Eye disorders | HYPER-CVAD | 1 | 215 | 1 |
| serious | Sepsis | Infections and infestations | HYPER-CVAD | 1 | 215 | 1 |
| serious | Neutropenic Fever | Infections and infestations | HYPER-CVAD | 34 | 215 | 60 |
| serious | Hemorrhage CNS | Blood and lymphatic system disorders | HYPER-CVAD | 1 | 215 | 1 |
| serious | Nausea/Vomiting | Gastrointestinal disorders | HYPER-CVAD | 3 | 215 | 3 |
| serious | Infection | Infections and infestations | HYPER-CVAD | 32 | 215 | 54 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HYPER-CVAD | 25 | 215 |
| Total, other adverse events | HYPER-CVAD | 24 | 220 |
| Total, serious adverse events | HYPER-CVAD | 61 | 215 |
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/NCT00671658
GET https://conductscience.org/api/trials/v1/NCT00671658/events?page=2