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HAPLOIDENTICAL BONE MARROW TRANSPLANTATION FROM NK ALLOREACTIVE DONORS FOR PATIENTS WITH HIGH RISK ACUTE MYELOID LEUKEMIA - A PHASE 2 STUDY

HAPLOIDENTICAL BONE MARROW TRANSPLANTATION FROM NK ALLOREACTIVE DONORS FOR PATIENTS WITH HIGH RISK ACUTE MYELOID LEUKEMIA - A PHASE 2 STUDY - NK alloreactive haploidentical bone marrow transplantation for leukemia

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40743
Enrollment
27
Registered
2014-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

acute leukemia cancer of the bone marrow

Interventions

Bone marrow is harvested under anesthesia in accordance to standard procedure from a NK cell alloreactive haploidentical family donor. Prior to bone marrow transplantation, the patient is treated wi

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: AML/RAEB patients 0.6 - Relapsed AML and susceptible for NK-cell alloreactivity and the availability of a NK cell alloreactive haploidentical bone marrow donor and Written informed consent

Exclusion criteria

Exclusion criteria: - Active uncontrolled infections - Uncontrolled CNS involvement by the malignant disease - Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease); - Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix ???); - Severe neurological or psychiatric disease; - Significant hepatic dysfunction (serum bilirubin or transaminases >= 3 times upper limit of normal) - Significant renal dysfunction (creatinine clearance

Design outcomes

Primary

MeasureTime frame
1-year progression-free survival from the start of chemotherapy treatment immediately prior to the bone marrow transplantation.—

Secondary

MeasureTime frame
- Best response on study - Engraftment after haploBMT (i.e. to what extent blood cells will be produced by donor bone marrow cells) - Incidence and severity of acute GVHD and chronic GVHD - (Serious) adverse events - Overall Survival (OS) from registration - Incidence and time to AML relapse - NRM at day +100 and at 1-year - Evaluation of infections during the first year after haploBMT - Quality of Life at 6 and 12 months after haploBMT - Costs of donor search, haploBMT itself and of follow-up and possible complications during the first year after haploBMT - NK cell repertoire recovery and maturation rate including the attainment of alloreactive potential - T and B cell recovery—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)