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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
treosulfan
How many people
30 participants
Where
1 siteFrance
Study dates
Feb 2005to not given
Phase
Phase 2
Are there results?
None posted in the registry

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.

Mauricette MICHALLET, MD contact

33 472 117 329

mauricette.michallet@chu-lyon.fr

France1 site, 1 recruiting

  • Hôpital Edouard Herriot

    Lyon, 69437

    Mauricette MICHALLET, MD, 33 472 117 329, mauricette.michallet@chu-lyon.fr

    Mauricette Michallet, MD

    Recruiting

Other trials in France

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.

  1. Overall survival at 1 year

Secondary outcomes (5)

  1. Engraftment evaluation

  2. Acute and chronic graft-versus-host disease incidence and severity

  3. Response rate and survival without progression

  4. Evaluation of conditioning and transplant toxicity

  5. Chimerism evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2005 (estimated)
  2. Study startFeb 2005

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mauricette MICHALLET, MD (33 472 117 329, mauricette.michallet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival at 1 year. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00129155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2007.

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