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NCT00504764COMPLETEDanonymous

APL-R2007: Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)

Sponsor

Source record

PETHEMA Foundation

Phase

Source record

Phase 4

Modality

AI-normalized

small molecule

Target

AI-normalized

PML/RARa fusion protein in acute promyelocytic leukemia (APL) cells, with a focus on apoptosis induction and differentiation of APL blasts.

Indication / condition

AI-normalized

Acute Promyelocytic Leukemia

Intervention

Source record

Arsenic Trioxide, Autologous Transplantation, Allogenic Transplantation, ATRA

Source & freshness

Source record

NCT ID

NCT00504764

Original source

ClinicalTrials.gov

Source last updated

Oct 28, 2014

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

NCT00504764

Title

APL-R2007: Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)

Sponsor

PETHEMA Foundation

Status

COMPLETED

Phase

Phase 4

Condition raw

Acute Promyelocytic Leukemia

Condition normalized

Acute Promyelocytic Leukemia

Modality raw

small molecule

Modality normalized

small molecule

Target raw

PML/RARa fusion protein in acute promyelocytic leukemia (APL) cells, with a focus on apoptosis induction and differentiation of APL blasts.

Target normalized

PML/RARa fusion protein in acute promyelocytic leukemia (APL) cells, with a focus on apoptosis induction and differentiation of APL blasts.

Interventions

Arsenic Trioxide, Autologous Transplantation, Allogenic Transplantation, ATRA

Public preview

Source record

The APL-R2007 trial, sponsored by the PETHEMA Foundation, investigates the efficacy of arsenic trioxide (ATO) in treating relapsed acute promyelocytic leukemia (APL). ATO has demonstrated remission rates exceeding 80% in prior studies and is already approved for relapsed and refractory APL in both Europe and the USA. The market for APL therapies is competitive, with ATRA and other agents also in use. The trial's findings could reinforce ATO's position in the treatment landscape, particularly for patients not eligible for transplantation. Given the high relapse rates associated with APL, successful outcomes could lead to increased adoption of ATO in clinical practice, impacting market share and revenue potential for the PETHEMA Foundation and potential partners. Diligence should focus on the long-term safety profile and comparative efficacy against existing therapies.

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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