---
title: MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
nct_id: NCT00129155
overall_status: UNKNOWN
phase: PHASE2
sponsor: Hospices Civils de Lyon
study_type: INTERVENTIONAL
primary_condition: Hematological Malignancies
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00129155.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00129155"
ct_last_update_post_date: 2007-10-04
last_seen_at: "2026-05-12T06:44:53.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

**Official Title:** Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

**NCT ID:** [NCT00129155](https://clinicaltrials.gov/study/NCT00129155)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Hospices Civils de Lyon
- **Conditions:** Hematological Malignancies, Allogeneic Transplantation
- **Start Date:** 2005-02
- **CT.gov Last Update:** 2007-10-04

## Brief Summary

In this study, treosulfan is evaluated for conditioning in allogenic stem cell transplantation. The procedure and the follow-up are the same as in standard allogenic transplant.

The donor is unrelated (identical HLA). The graft is haematological peripheral blood stem cell.

The conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* AGE: \>= 18 years and \<= 65 years
* Patients with a too high transplant-related mortality (TRM) after standard transplantation (multiple myeloma, chronic lymphoid leukemia, non Hodgkin's lymphoma, myelodysplasia)
* Patients with visceral contra-indication for standard transplantation:

  * cardiac: myocardiopathy; forced expiratory volume (FEV) \< 50%;
  * respiratory: abnormal carbon monoxide diffusing capacity (DLCO);
  * renal: creatinine clearance \< 50ml/min;
  * hepatic: transaminases and bilirubin \> 2 upper normal limit;
  * infectious: controlled fungal infection.
* Karnofsky score \>= 70%
* Unrelated donor HLA identical (ABC, DRB1; DQB1)
* Signed informed consent

Diagnosis :

Chronic myelogenous leukemia (CML):

* In first chronic phase, resistant to interferon with or without aracytine or refractory or resistant to Glivec
* In complete response (CR) or in 2nd partial response (PR) after being in blastic phase

Multiple myeloma (MM):

* Relapse after autograft if the therapeutic response was evaluated to 50%

Non-Hodgkin's lymphoma (NHL):

* Mantle cell lymphoma after first relapse but in case of chemosensitivity ≥ 50% except for high grade lymphoma
* In 2nd CR or PR chemosensitive in response ≥ 50% after autograft

Chronic lymphocytic leukemia (CLL):

* In 2nd CR or PR or in response ≥ 50% after autograft or in 2nd relapse after 2 lines of treatment but in case of chemosensitivity ≥ 50%

Acute myeloid leukemia (AML):

* In 2nd CR or in 1st CR for high risk criteria \[high risk criteria defined by: LAM 7; leukocytes \> 30,000/mm3; chromosomal abnormalities: t(6,9); abnormalities of 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q et inv 3q\]

Acute lymphoblastic leukemia (ALL):

* In 2nd CR or in 1st CR if high risk criteria patients who are defined by chromosomal abnormalities t(9,22); t(1,19); t(4,11); abnormalities of 11q23

Myelodysplastic syndromes (MDS):

* Patients without prior chemotherapy, with intermediate or high International Prognostic Scoring System (IPSS) score and blast cells \< 1% in bone marrow (BM)
* CR or PR after chemotherapy for patients with 20 to 30% of blast cells in BM
* Secondary AML patients with a response to chemotherapy (\< 30% blasts in BM and \< 5% of blast cells in blood)

For all:

* Adequate contraception in female patients of child bearing potential
```

## Interventions

- **treosulfan** (DRUG)

## Primary Outcomes

- **Overall survival at 1 year**

## Secondary Outcomes

- **Engraftment evaluation**
- **Acute and chronic graft-versus-host disease incidence and severity**
- **Response rate and survival without progression**
- **Evaluation of conditioning and transplant toxicity**
- **Chimerism evaluation**

## Locations (1)

- Hôpital Edouard Herriot, Lyon, France — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hôpital edouard herriot|lyon||france` — added _(2026-05-12)_

---

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