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NCT00079378COMPLETEDanonymous

A Phase I Study of Decitabine in Combination With Valproic Acid in Patients With Selected Hematologic Malignancies

Sponsor

Source record

National Cancer Institute (NCI)

Phase

Source record

Phase 1

Modality

AI-normalized

small molecule

Target

AI-normalized

Decitabine targets DNA methylation processes, while Valproic Acid inhibits histone deacetylases, potentially enhancing the efficacy of decitabine in treating hematologic malignancies.

Indication / condition

AI-normalized

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Intervention

Source record

decitabine, valproic acid, pharmacological study, laboratory biomarker analysis

Source & freshness

Source record

NCT ID

NCT00079378

Original source

ClinicalTrials.gov

Source last updated

Sep 30, 2013

Ingested at

Jun 12, 2026

Internal sync

Jun 12, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT00079378

Title

A Phase I Study of Decitabine in Combination With Valproic Acid in Patients With Selected Hematologic Malignancies

Sponsor

National Cancer Institute (NCI)

Status

COMPLETED

Phase

Phase 1

Condition raw

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Recurrent Adult Acute Myeloid Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Untreated Adult Acute Myeloid Leukemia

Condition normalized

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Recurrent Adult Acute Myeloid Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Untreated Adult Acute Myeloid Leukemia

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Decitabine targets DNA methylation processes, while Valproic Acid inhibits histone deacetylases, potentially enhancing the efficacy of decitabine in treating hematologic malignancies.

Target normalized

Decitabine targets DNA methylation processes, while Valproic Acid inhibits histone deacetylases, potentially enhancing the efficacy of decitabine in treating hematologic malignancies.

Interventions

decitabine, valproic acid, pharmacological study, laboratory biomarker analysis

Public preview

Source record

The Phase I study of Decitabine in combination with Valproic Acid is sponsored by the National Cancer Institute and focuses on patients with refractory or relapsed acute myeloid leukemia (AML) and previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The combination therapy aims to improve treatment outcomes by leveraging the distinct mechanisms of action of both agents. Given the high unmet medical need in these patient populations, successful outcomes could position this combination as a competitive option in the oncology market. The results may also provide insights into the broader application of epigenetic therapies in hematologic cancers, potentially attracting interest from pharmaceutical companies looking to expand their oncology portfolios.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Phase I Study of Decitabine in Combination With Valproic Acid in Patients With Selected Hematologic Malignancies

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT00079378

Status

COMPLETED

Phase

Phase 1

Sponsor

National Cancer Institute (NCI)

Executive brief

Investment-Ready Snapshot

The Phase I study of Decitabine in combination with Valproic Acid is sponsored by the National Cancer Institute and focuses on patients with refractory or relapsed acute myeloid leukemia (AML) and previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The combination therapy aims to improve treatment outcomes by leveraging the distinct mechanisms of action of both agents. Given the high unmet medical need in these patient populations, successful outcomes could position this combination as a competitive option in the oncology market. The results may also provide insights into the broader application of epigenetic therapies in hematologic cancers, potentially attracting interest from pharmaceutical companies looking to expand their oncology portfolios.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedSep 30, 2013
Internal syncJun 12, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT00079378

Indication

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Modality

small molecule

Target

Decitabine targets DNA methylation processes, while Valproic Acid inhibits histone deacetylases, potentially enhancing the efficacy of decitabine in treating hematologic malignancies.

Intervention

decitabine, valproic acid, pharmacological study, laboratory biomarker analysis

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.