Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00326170 · ClinicalTrials.gov registry record · Phase 2
Phase II 5-Azacytidine Plus VPA Plus ATRA
A Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT00326170: Completed Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT00326170 is a Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 34 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00326170, a Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.
Primary Outcome
Clinical activity of combination defined as: Complete Response (CR), bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10\^9/L or more and platelet count of 100x10\^9 or more; Complete response without platelets (CRp), a complete response except for a platelet count less than 100x10\^9 and transfusion independent; and Bone Marrow (BM) Response, bone marrow blast of 5% or less but without meeting the peripheral blood count criteria for (CR) or (CR
Conditions Studied
Interventions
- DRUG Valproic Acid
- DRUG All-Trans Retinoic Acid (ATRA)
- DRUG 5-Azacytidine (5-aza)
Study Locations (1)
Texas
- The University of Texas M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2005-07 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
What the finished NCT00326170 record still lists
NCT00326170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Valproic Acid is the first listed.
NCT00326170 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00326170 about?
NCT00326170 is a clinical study titled "Phase II 5-Azacytidine Plus VPA Plus ATRA". 5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA)...
What is the current status of trial NCT00326170?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2005-07. Estimated completion is 2007-12.
What conditions does trial NCT00326170 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT00326170?
The interventions under investigation include: Valproic Acid (DRUG), All-Trans Retinoic Acid (ATRA) (DRUG), 5-Azacytidine (5-aza) (DRUG).
Who is sponsoring clinical trial NCT00326170?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00326170 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00326170's enrollment target sits among peer trials
34 87th of 134 higher than 47 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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
-
Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant
RECRUITING · Phase 2
-
Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation
RECRUITING · Phase 2
-
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
RECRUITING · Phase 2
-
CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
RECRUITING · Phase 2
-
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
RECRUITING · Phase 2
-
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia