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ALT-801-activated Natural Killer Cells After FLAG Induction for Acute Myeloid Leukemia

NCT01478074 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-01-03

No results posted yet for this study

Summary

This is a single-center open-label phase I clinical trial of delivering haploidentical natural killer (NK) cells matured ex vivo with ALT-801 followed by intravenous infusions of ALT-801 in patients with relapsed/refractory Acute Myeloid Leukemia (AML). The study will be conducted at M.D. Anderson Cancer Center (MDACC) and MDACC Children's Cancer Hospital in Houston, Texas.

Conditions

Interventions

DRUG

G-CSF

5 mcg/kg daily from day -7 until post-nadir ANC \> 1000

DRUG

Cytarabine

2 g/m2 daily from day -6 through -2

DRUG

Fludarabine

30 mg/m2 daily from day -6 through -2

BIOLOGICAL

Donor Natural Killer (NK) cells

Infused once on day 0. Four cohorts of escalating doses receiving 0, 1, 10, or 20 x 10\^6 cells/Kg

BIOLOGICAL

ALT-801

0.04 mg/kg IV thrice weekly for 8 doses beginning day +2

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Altor BioScience

    lead INDUSTRY

Principal Investigators

  • Hing C Wong, PhD · Altor BioScience

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-10-31
Completion
2013-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478074 on ClinicalTrials.gov