A Phase l/ll study to assess safety of co-infusion of haematopoietic stem cells from a haplo-identical donor and single unit unrelated cord blood in patients with a high risk of relapse

Phase 2

Withdrawn

• Conditions: cancer; malignancy; 10024324

• Registration Number: NL-OMON34968
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 43

Inclusion Criteria

All of the following five criteria:;1) All patients qualifying for allogenic hematopoietic stem cell transplantation (HSCT) (based on national or international study protocols) with a malignancy and either:

- Relapse after first transplant with a SIB or MUD/UCB donor
- Having NHL or HD (refractory, *2CR) for which no standard allo-transplantation protocols are available, or ALL *CR2 if not eligible to other running SCT protocols.
- Having relapse AML/ refractory AML
- Problems finding a donor: no fully matched family donor or matched (9-10/10) unrelated donor available and / or no single or double unit cord blood available with sufficient cell numbers according to ongoing, open study protocols.
2) having a single matching (* 4/6) umbilical CB unit available with total NC count > 1,5 E7/kg [22]
3) Lansky / Karnofsky > 40
4) Age 0-65 * (*<= age * 65 and 364 days )
5) Signed Informed Consent

Exclusion Criteria

- Lansky < 40
- No cord blood unit available wih <=4/6 match en a minimum cell dose of > 1,5 x 10E7 Nucleated cells /kg
-no informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The cumulative incidence of transplant related death (transplant related<br /><br>mortality: TRM, non-relapse mortality< 100 days Post HSCT)<br /><br>The cumulative incidence of acute- GVHD (Grades II-IV: Gluckberg Criteria)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Engraftment: Neutrophils > 500K/uL for 3 consecutive days, Platelet (day 180<br /><br>> 50 K) engraftment.<br /><br>- Event Free Survival (>6mths follow up). Event defined as: death, CB<br /><br>graft-failure (<25% donor CB chimerism) or relapse.<br /><br>- Overall Survival<br /><br>- Non-Relapse Mortality<br /><br>- Chronic GVHD: limited and extensive (Shulman Criteria)<br /><br>- VOD (Seattle Criteria)<br /><br>- Mucositis * 3 </p><br>