Main info

Identificatie:

HOVON 115 double UBCT

Sponsor:

HOVON

Working group party:

SCT & Supportive care

Age:

18-70

Stadium:

1st lijn

Echelon:

Level A

Included patients:

70

(of 70)

Active sites:

7

(of 7)

Title:

Double umbilical cord blood transplantation in high-risk hematological patients. A phase II study focusing on the mechanism of graft predominance

Timeline

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Not any more

Objectives:

• To study the presence of an alloreactive immune response of CD4+ T-cells of the predominant CBU, directed against the non-engrafting CBU as a causative mechanism in CBU predominance.
• To assess engraftment and engraftment kinetics;
• to evaluate immune reconstitution, acute and chronic GVHD, chimerism, toxicity, progression-free survival and overall survival after double unit UCBT.

Eligibility

Inclusion Criteria:

• Age 18-70 years inclusive
• Diagnosis of poor-risk hematological malignancy or (V)SAA relapsing after or failing immunosuppressive therapy and meeting the criteria for a MUD allo SCT
• 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 (≥4/6) matched UCB grafts with a total nuclear cell count > 4 x 107/kg (see paragraph 8.2).
• WHO performance status 0-2
• Written informed consent

Exclusion Criteria:

• 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 (≥ 8 Gy) total body irradiation
• Pregnant or lactating females
• HIV positivity

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals