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: A Phase l/ll study to assess safety and to investigate the biological mechanism of the anti-tumor response

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: A Phase l/ll study to assess safety and to investigate the biological mechanism of the anti-tumor response - Haplo-Cord Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35879

Enrollment

Registered

2011-09-12

Start date

2011-10-24

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hematological malignancy leukemia

Interventions

For a group of patients with a very high risk malignancy: Instead of using a single donor, or no transplantation at all, a combination of a cord blood unit and selected cells from a haplo-identical

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All of the following five criteria: 1) Patients with either: A) No standard HSCT protocol available and any of the following malignancies: NHL or HD (refractory, *2CR); relapse AML, refractory AML, MDS/SAA, ALL *CR2 B) Relapse after first allo-HSCT with either SIB or MUD/UCB donor C) With a leukemia/lymphoma, MDS/SAA indication, qualifying for HSCT but without donor available according to ongoing, open study protocols (only adults): 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) With having a single matching (* 4/6) umbilical CB unit available with total NC count > 1,5 E7/kg [1] 3) Lansky / Karnofsky > 40 4) Age 18-65 * (*

Exclusion criteria

Exclusion criteria: - geen getekende toestemingsverklaring - Lansky 1,5 x 10E7 Nucleated cells /kg - Creatinine clearance

Design outcomes

Primary

Measure	Time frame
1) Safety: Transplantation related (non-relapse) mortality (TRM) 2) Biology: investigate the anti-tumor response mechanism from both grafts.	—

Secondary

Measure	Time frame
-acute GVHD (Gluckberg grade II-IV) Engraftment: Neutrophils > 500K/uL for 3 consecutive days, Platelet (day 180 > 50 K) engraftment. - Event Free Survival (>6mths follow up). Event defined as: death, CB graft-failure (	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)