To evaluate LFS after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Leukemia-free survival (LFS)
Secondary outcome
- Overall survival (median survival if possible; otherwise survival until 40%
or 30% alive)
- Incidence of relapse
- Incidence of myelosuppression (ANC < 500/mm³ for > 2 days, platelets <
20,000/mm³ for > 2 days) after initial PBSC infusion
- Incidence of aplasia after DLI
- Incidence of grades 2-4 acute GvHD after transplant
- Incidence of grades 2-4 acute GvHD after DLI
- Incidence of grades chronic extensive GvHD after DLI
Background summary
Allografting using high dose regimens has been shown to reduce relapse of AML
in patients at all stages of disease and is the only curative treatment for
many patients. Older patients however do not tolerate the high-dose regimens.
Phase I/II studies using related and unrelated donors have shown that
allogeneic hematopoietic cell transplantation (HCT) after reduced intensity
conditioning is feasible with minimal toxicity in older AML patients and that
patients may remain long term disease free after allogeneic transplantation.In
the present intergroup protocol we plan to analyse the role of allogeneic HCT
from related and unrelated donors in comparison to chemotherapy in patients
between 60-75 yrs of age with newly diagnosed AML and in CR1 after one or 2
induction cycles.
Study objective
To evaluate LFS after allo HCT in AML/RAEB in complete remission using matched
or unrelated donors in comparison to conventional chemotherapy
Study design
Randomised, multicenter, phae III
Intervention
Patients with a donor will be randomized between standard treatment and
treatment with
Fludarabine, 200 cGy TBI and allogeneic HCT followed by immunosuppression with
CyA and MMF. For patients of 60-65 years the standard treatment is autologous
HCT or chemotherapy. Patients of 66 years and older will receive no further
treatment. This also applies to both groups of patients without a donor.
Patients are entered in CR1 after induction chemotherapy. Induction is
according to each participating centre or study group, which applies their own
protocols.
Study burden and risks
Dependig on certain risk factors there is an increased mortality risk caused by
immundeficiency which occurs when treating graft failure. This risk is about
20-30%
12th Floor Tower wing, Guy's hospital, Great Maze pond 12
SE1 9RT London 1900SE
GB
12th Floor Tower wing, Guy's hospital, Great Maze pond 12
SE1 9RT London 1900SE
GB
Listed location countries
Age
Inclusion criteria
- Age >= 60years and <= 75 years
- AML as defined by WHO
- Refractory anaemia with excess of blasts (RAEB)
- primary and secondary AML
- First complete remission following one or two cycles of induction chemotherapy, according to current participating cooperative group protocols
- Karnofsky score > 70%
- Written informed consent
Exclusion criteria
- AML FAB M3
- Organ dysfunction
* Patients with creatinine clearance < 50 ml/min
* Cardiac ejection fraction < 40%
* Severe defects in pulmonary function testing as defined by the pulmonary consultant, or receiving supplementary continuous oxygen
* Liver function tests: total bilirubin > 2x the upper limit of normal, SGOT and SGPT 4x the upper limit of normal
- Karnofsky score < 70%
- Patients with poorly controlled hypertension
- HIV positivity
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003514-34-NL |
| ClinicalTrials.gov | NCT00766779 |
| CCMO | NL24236.000.08 |