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MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00129155
Enrollment
30
Registered
2005-08-11
Start date
2005-02-28
Completion date
Unknown
Last updated
2007-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Transplantation, Hematological Malignancies

Keywords

Allogenic stem cell transplantation, Treosulfan, Haematological malignancies, allogeneic stem cell transplantation in patients with hematological malignancies

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).

Interventions

DRUGtreosulfan

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Overall survival at 1 year

Secondary

MeasureTime frame
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

Countries

France

Contacts

Primary ContactMauricette MICHALLET, MD
mauricette.michallet@chu-lyon.fr33 472 117 329

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026