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NCT02096055 · ClinicalTrials.gov registry record · Phase 2
Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT02096055: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02096055 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02096055, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well guadecitabine with or without idarubicin or cladribine works in treating older patients with previously untreated acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether guadecitabine with or without idarubicin or cladribine is more effective in treating older patients with previously untreated acute myeloid leukemia.
Primary Outcome
Complete Response = Complete Remission (CR) + Complete Remission without blood count recovery (CRi) - CR: Neutrophil count \>/= 1.0 x 10\^9/L and platelet count \>/= 100 x 10\^9/L, and normal bone marrow differential (\</+ 5% blasts). (CRi): Peripheral blood and bonemarrow results as for CR, but with platelet counts of \< 100 x 109/L or ANC \< 1.0 x 109/L
Interventions
- DRUG Cladribine
- DRUG Idarubicin
- DRUG Guadecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2014-04-04 |
| Est. Completion | 2020-11-24 |
| Phase | Phase 2 |
What the finished NCT02096055 record still lists
NCT02096055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Cladribine is the first listed.
NCT02096055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02096055 about?
NCT02096055 is a clinical study titled "Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia". This randomized phase II trial studies how well guadecitabine with or without idarubicin or cladribine works in treating older patients with previously untreated acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs us...
What is the current status of trial NCT02096055?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2014-04-04. Estimated completion is 2020-11-24.
What interventions are being tested in trial NCT02096055?
The interventions under investigation include: Cladribine (DRUG), Idarubicin (DRUG), Guadecitabine (DRUG).
Who is sponsoring clinical trial NCT02096055?
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 NCT02096055's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 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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