Hematological MalignanciesPhase 2NCT00129155
MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
A Phase 2 study testing treosulfan in people with Hematological Malignancies and Allogeneic Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematological Malignancies, Allogeneic Transplantation
- What is being tested?
- treosulfan
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2005to not given
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 32Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Edouard Herriot
Lyon, 69437
Mauricette MICHALLET, MD, 33 472 117 329, mauricette.michallet@chu-lyon.fr
Mauricette Michallet, MD
About this study
Official title: Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
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).
- Being tested
- treosulfan
- Keywords
- Allogenic stem cell transplantation, Treosulfan, Haematological malignancies, allogeneic stem cell transplantation in patients with hematological malignancies
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treosulfanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 1 year
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Mauricette MICHALLET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129155
- Sponsor's protocol ID
- 2003.332
- Status last verified
- Oct 2007
- First submitted
- 9 Aug 2005
- Last updated
- 4 Oct 2007
- Results posted
- No