Main info

Identifier:

HO106 SCT

Sponsor:

HOVON

Working group party:

SCT & Supportive care

Age:

18-65

Stage:

2nd Line

Echelon:

Level A

Included patients:

60

(of 61)

Active sites:

6

(of 5)

Title:

'A phase II study to assess engraftment and engraftment kinetics after double cord
blood transplantation with a reduced-intensity conditioning regimen in patients
eligible for allogeneic stem cell transplantation lacking a matched unrelated donor.'

Timeline

News

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Not any more

Objectives:

• To assess engraftment and engraftment kinetics after double cord blood transplantation preceded by a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor.
• To evaluate immune reconstitution, acute and chronic GVHD, chimerism, toxicity, time to treatment failure, progression-free survival and overall survival after double unit UCBT.
• To study patient-versus-graft, graft-versus-patient and graft-versus-graft interactions

Eligibility

Inclusion Criteria:

Age 18-65 years inclusive

• Meeting the criteria for a MUD allo SCT and high risk disease (see below)
• Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required time period of ≤ 2 months in case of urgently needed alloSCT
• Availability of 2 sufficiently matched UCB grafts with a total nuclear cell count > 4 x 10^7/kg
• WHO performance status ≤ 2
• Written informed consent

High risk disease as defined by:

• AML with -5, -7, EVI-1-expression or complex karyotype in first CR
• Relapsed AML/ MDS in second or subsequent CR
• ALL with t(9;22), t(4;11), t(1;19) or with high WBC at diagnosis (B-ALL > 30x10^9/l, T-ALL > 100x10^9/l) in first CR, or no CR after first induction but in CR after rescue chemotherapy
• Relapsed ALL in second or subsequent CR
• CML in second chronic phase after treatment for CML blast crisis
• VSAA or SAA relapsing after or failing immunosuppressive therapy

Patients with the following diseases may be included if considered high risk disease:

• Relapse AML with t(8;21) or inv16 in second or subsequent CR, with poor risk according to Breems prognostic score (appendix A)
• AML/MDS in patients 61-65 years inclusive, in first CR
• CML in second chronic phase after treatment for acceleration phase
• Lymphocytoplasmacytoid lymphoma, responsive disease after at least third line chemotherapy
• Folliculair NHL, responsive disease after at least third line chemotherapy
• CLL, responsive disease after at least third line chemotherapy

Exclusion Criteria:

• Relapse APL
• Primary myelofibrosis
• Bilirubin and/or transaminases > 2.5 x normal value
• Creatinine clearance < 40 ml/min
• Cardiac dysfunction as defined by:
• Reduced left ventricular function with an ejection fraction < 45% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
• Unstable angina
• Unstable cardiac arrhythmias
• Pulmonary function test with VC, FEV1 and/ or DCO < 50%
• Active, uncontrolled infection
• History of high dose total body irradiation
• HIV positivity

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals