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NCT01319981 · ClinicalTrials.gov registry record · Phase 2
Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01319981: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01319981 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01319981, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if intensive chemotherapy (hyper-CVAD therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab for patients who are CD20 positive and/or imatinib, dasatinib, or ruxolitinib for patients with the Philadelphia (Ph) chromosome, can help to control ALL or lymphoblastic lymphoma. The safety of this treatment will also be studied. CD20 is a protein "marker" that is found in leukemia or lymphoma cells. This is an investigational study. Liposomal vincristine is FDA approved for the treatment of patients with CLL who have relapsed at least 2 times. All of the other study drugs used in this study are FDA approved and commercially available. The combination of liposomal vincristine with the other study drugs is also being used in research only. Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.
Primary Outcome
The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of \</=5% blasts in the bone marrow, with \>1x10\^9/L neutrophils, \>100x10\^9/L platelets in the perpherial blood, and no extramedullary disease.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Mesna
- DRUG Rituximab
- DRUG Imatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-03-05 |
| Est. Completion | 2020-11-11 |
| Phase | Phase 2 |
What the finished NCT01319981 record still lists
NCT01319981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01319981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01319981 about?
NCT01319981 is a clinical study titled "Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia". Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if intensive chemotherapy (hyper-CVAD therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab for patie...
What is the current status of trial NCT01319981?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2013-03-05. Estimated completion is 2020-11-11.
What interventions are being tested in trial NCT01319981?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Mesna (DRUG), Rituximab (DRUG), Imatinib (DRUG).
Who is sponsoring clinical trial NCT01319981?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01319981's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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