Phase 2
N=6
Alloreactive Haploidentical Natural Killer (NK) Cells With Busulfan and Fludarabine/ATG
Leukemia · Chronic Myelogenous Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01390402 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Number of Participants With Molecular Complete Remission at 3 Month Post Transplant — 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Busulfan (Drug); NK cell infusion: (Procedure); Interleukin-2 (Drug); Anti-Thymocyte Globulin (Drug); Allogeneic related Stem Cell Transplant (Procedure); Tacrolimus (Drug); Methotrexate (Drug); G-CSF (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Molecular Complete Remission at 3 Month Post Transplant |
3 | — |
Summary
The goal of this clinical research study is to learn if giving a kind of immune cell called natural killer (NK) cells after chemotherapy will improve the response to a stem cell transplant in patients with CML. The safety of this treatment will also be studied.
Eligibility Criteria
Inclusion Criteria
- Patients who meet the following eligibility criteria are eligible for inclusion in this study. Pediatric team to assess eligibility appropriate for patient age.
- Age 18 months, or e) loss of a response with increasing cytogenetic or molecular evidence of disease. Or are intolerant to tyrosine kinase inhibitor therapy. Or with second or greater chronic phase (with prior transformation who respond to treatment and have /= 40%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
- Pulmonary function: no symptomatic pulmonary disease. forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) >/= 50% of expected, corrected for hemoglobin. For pediatric patients, if unable to perform pulmonary function tests (most children /= 92% on room air by pulse oximetry.
- Renal function: Serum creatinine 1L
- HIV-positive.
- Breast feeding or pregnancy. Pregnancy means a positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known allergy to mouse proteins
- Active hepatitis B or C infection.
Data sourced from ClinicalTrials.gov (NCT01390402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.