Clinical trial NCT00129155: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hematological Malignancies
Allogeneic Transplantation
Keywords: Allogenic stem cell transplantation
Treosulfan
Haematological malignancies
allogeneic stem cell transplantation in patients with hematological malignancies
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Overall survival at 1 year
Secondary outcomes:
measure: Engraftment evaluation
measure: Acute and chronic graft-versus-host disease incidence and severity
measure: Response rate and survival without progression
measure: Evaluation of conditioning and transplant toxicity
measure: Chimerism evaluation
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Mauricette MICHALLET, MD
role: PRINCIPAL_INVESTIGATOR
References: