NCT02646839
KIR Favorable Mismatched Haplo Transplant and KIR Polymorphism in ALL/AML/MDS Allo-HCT Children
Enrolling by Invitation
PHASE2Up to 21InterventionalTreatmentMichael PulsipherInvestigator-initiated
~50 participants
Updated 2025-05-04 on ClinicalTrials.gov
What's tested:CliniMacs TCR alpha-beta-Biotin system
At a glance
Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease free survival at 1 year post HCT
Measured over 1 year
+1 more outcome measured
Conditions
Where it's being run
11 sites across 7 statesCalifornia5
Illinois1
New York1
Pennsylvania1
Tennessee1
Utah1
Wisconsin1
Study leadership
- Michael Pulsipher, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
ALL high-risk in first remission (\<5% blasts by morphology pre-transplant) meeting criteria for transplant. Example CR1 indications: induction failure (\>5% blasts by morphology on post-induction BM), minimal residual disease greater than or equal to 1% marrow blasts by morphology after induction, minimal residual disease by flow cytometry \>0.01% after consolidation, hypodiploidy (\<44 chromosomes), persistent or recurrent cytogenetic or molecular evidence of disease during therapy requiring additional therapy after induction to achieve remission (e.g. persistent molecular BCR-ABL positivity).
ALL in second remission: B-cell; early (less than or equal to 36 months from initiation of therapy) BM relapse, late BM relapse with MRD \>0.1% by flow cytometry after first induction therapy; T-cell or Ph+ with BM relapse at any time; very early (less than 18 months from initiation of therapy) isolated extramedullary relapse (T or B-cell)
Myelodysplastic syndrome (MDS): Any 2001 WHO classification subtype (Appendix I). RAEB-2 patients may proceed directly to transplant, but may also receive induction chemotherapy before transplant. Patients with ≥20% morphologic marrow blasts will require induction therapy to reduce morphologic marrow blasts below 5% before transplant.
High-risk AML defined as monosomy 5, del 5q, monosomy 7, M6, M7, t(6;9), FLT3-ITD, or patients who have greater than or equal to 25% blasts by morphology after induction, or who do not achieve CR after 2 courses of therapy. Also, patients with ≥ 0.1% MRD or evidence of progressive extramedullary disease after induction chemotherapy.
AML in second or subsequent morphologic remission. 3. Has not received a prior allogeneic hematopoietic stem cell transplant. 4. Does not have a suitable HLA-matched sibling donor available for stem cell donation. 5. Does not have a suitable matched or single antigen mismatched related or unrelated donor available at any time (noted by search), or it is in the patient's best interest as judged by the attending to move forward with stem cell transplantation rather than wait for an unrelated donor to become available (refer to subsection 2.5.1 for further details). 6. Has a suitable HLA KIR favorable haploidentical matched family member available for stem cell donation. 7. Karnofsky Index or Lansky Play-Performance Scale ≥ 60 % on pre-transplant evaluation. Karnofsky scores must be used for patients \> 16 years of age and Lansky scores for patients \< 16 years of age. 8. Able to give informed consent if \> 18 years, or with a legal guardian capable of giving informed consent if \< 18 years. 9. Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:
Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.
Renal: Creatinine clearance or radioisotope GFR ³ 70 mL/min/1.73 m2 or a serum creatinine based on age/gender as follows:
Cardiac: Shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA), choice of test according to local standard of care.
Hepatic: \\SGOT (AST) or SGPT (ALT) \< 5 x upper limit of normal (ULN) for age. Conjugated bilirubin \< 2.5 mg/dL, unless attributable to Gilbert's Syndrome.
What this trial measures
- Disease free survival at 1 year post HCT1 year
- 1 yr disease free survival of patients transplanted with donors homozygous for KIR2DL1-C245 will be compared to patients with donors hetero- or homozygous for KIRD2DL1-R245 polymorphisms1 year