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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status and phase

Unknown
Phase 2

Conditions

Hematological Malignancies
Allogeneic Transplantation

Treatments

Drug: treosulfan

Study type

Interventional

Funder types

Other

Identifiers

NCT00129155
2003.332

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Mauricette MICHALLET, MD

Data sourced from clinicaltrials.gov

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