HOVON HO53

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Main info

Identificatie:
HOVON 53 AML / OSHO
Sponsor:
HOVON
Included patients:
59
Active sites:
8
(of 10)
Title:

Allografting as Consolidative Immunotherapy for Older Patients with AML in Complete Remission Using Low Dose TBI, PBSC Infusion And Post-Transplant Immunosuppression With Cyclosporine And Mycophenolate Mofetil.

Timeline

Scheduled
Actual
2015
13 okt.
Archived
2030
13 okt.
Destruction

Details

Phase:
Prospective Phase II study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • Age 50-75 years, inclusive;
  • AML as defined by the HOVON/SAKK AML-43 protocol (M0-M2 and M4-M7, FAB classification);
  • Refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1,5 (Appendix A);
  • AML in first or later CR;
  • Have a HLA identical family donor or a HLA identical unrelated donor;
  • Karnofsky score > 70 (see appendix B);
  • Written informed consent.
Exclusion Criteria:
  • AML FAB M3;
  • Patients with a creatinine clearance < 50 ml/min;
  • Cardiac ejection fraction < 40%;
  • Severe defects in pulmonary function testing (defects are currently categorized as mild, moderate and severe) 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 <=60 (see appendix E );
  • Patients with poorly controlled hypertension;
  • HIV positivity;

Participating Sites

Site
8 results
Order by
Accrual rate
Activation date
NL-Rotterdam-EMCDANIEL
16
NL-Utrecht-UMCUTRECHT
16
NL-Maastricht-MUMC
9
CH-Zürich-USZ
6
NL-Amsterdam-VUMC
5
CH-Basel-USB
4
NL-Amsterdam-AMC
2
BE-Bruxelles-STLUC
1
= Active hospitals
= Inactive hospitals

Participating Parties

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