---
title: Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I
nct_id: NCT02981784
overall_status: COMPLETED
sponsor: Hospices Civils de Lyon
study_type: OBSERVATIONAL
primary_condition: Leukemia
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02981784.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02981784"
ct_last_update_post_date: 2016-12-05
last_seen_at: "2026-05-12T07:28:58.984Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I

**Official Title:** Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation

**NCT ID:** [NCT02981784](https://clinicaltrials.gov/study/NCT02981784)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 184
- **Lead Sponsor:** Hospices Civils de Lyon
- **Conditions:** Leukemia
- **Start Date:** 2000-01
- **Completion Date:** 2015-12
- **CT.gov Last Update:** 2016-12-05

## Brief Summary

Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* CML any phase with T315I mutation
* Ph+ ALL with a T315I mutation
* Being treated in the PACE trial according to the criteria of this phase II trial
* Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen.

Exclusion Criteria:

* Ph negative patients
* Patients under 18 years
```

## Arms

- **Ponatinib (PACE trial)** — PACE trial : "Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)", NCT01207440
- **Allogenis stem cell transplantation (EBMT registry)** — EBMT : European Group for Blood and Marrow Transplantation

## Interventions

- **Ponatinib (Iclusig®)** (DRUG) — Novel tyrosine kinase inhibitor active in patients with an ABL T315I mutation compared to conventional or reduced intensity allogeneic stem cell transplantation.
- **allogeneic stem cell transplantation** (PROCEDURE)

## Primary Outcomes

- **Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)** _(time frame: From date of inclusion until the date of death, assessed up to 180 months)_

## Locations (1)

- Centre Hospitalier Lyon-Sud, Pierre-Bénite, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre hospitalier lyon-sud|pierre-bénite||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02981784*  
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