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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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22000
Enrollment
37
Registered
2011-09-24
Start date
2011-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Allogeneic stem cell transplantation Haplo identical Cord blood High risk Hematological disease Allogene stamceltransplantatie Haplo identiek Navelstreng bloed Hoog risico hematologische ziekte

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

Sponsors

UMC Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion 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 indication, qualifying for HSCT but without donor available according to ongoing, open study protocols 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; 3. Lansky / Karnofsky > 40; 4. Age 18-65 * (*= age ≤ 65 and 364 days); 5. Signed Informed Consent.

Exclusion criteria

Exclusion criteria: 1. Creatinine clearance < 40 ml/min; 2. Cardiac dysfunction (SF < 30%) (Ejection fraction < 45%), unstable angina, or unstable cardiac arrhythmias; 3. Pulmonary function test VC, FEV1 and/ or DOC< 50%.

Design outcomes

Primary

MeasureTime frame
Safety: Transplantation related (non-relapse) mortality (TRM). Biology: Investigate the anti-tumor response mechanism from both grafts.—

Secondary

MeasureTime frame
1. Acute- GVHD ( Grade II-IV: Gluckberg Criteria); 2. Engraftment: Neutrophils > 500K/uL for 3 consecutive days and Platelet (day 180 > 50 K) engraftment; 3. Loss of CB chimerism (6 mths follow up). Event defined as: Death, graft-failure (<25% total donor chimerism) or relapse; 5. Non-Relapse Mortality; 6. Overall Survival; 7. Chronic GVHD: Limited and extensive (Shulman Criteria); 8. VOD (Seattle Criteria); 9. Mucositis &#8805; CTC grade 3.—

Contacts

Public ContactJ.H.E. Kuball

UMCU, Dept. of Hematology B02.226 Heidelberglaan 100

J.H.E.Kuball@umcutrecht.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)