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CNDO-109-AANK for AML in First Complete Remission (CR1) | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

CNDO-109-AANK for AML in First Complete Remission (CR1)

A Phase 1/2 Study of CNDO-109-Activated Allogeneic Natural Killer Cells in Patients With High Risk Acute Myeloid Leukemia in First Complete Remission (CR1)

NCT01520558•Coronado Biosciences, Inc.

View on ClinicalTrials.gov

Summary

This is a multi-center, open-label, non-controlled, non-randomized dose-escalating Phase 1 clinical study designed to examine the safety of infusing escalating doses of CNDO-109-Activated Allogeneic Natural Killer Cells-(from a first or second degree relative), after a preparatory chemotherapy regimen, in adult patients with acute myeloid leukemia (AML) who are in their first complete remission at the time of enrollment, are not candidates for stem cell transplant, and are considered to be at high risk for recurrence.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient has pathologically documented AML and is in CR1 at the time of the screening visit
•2. The patient achieved CR1 within 10 weeks of the screening visit; the patient may have received post-remission consolidation therapy (except for transplant) prior to the screening visit
•3. A bone marrow aspiration performed within 21 days prior to the start of pre-infusion preparative therapy confirms the patient is in CR1
•4. The patient has either refused or is not considered an appropriate immediate candidate for transplantation and is considered to be at high risk for recurrence by having at least one of the following prognostic factors:
•* High risk cytogenetics (-5, -7, del(5q), abnormal 3q, 11q23 translocations, complex cytogenetics) or if cytogenetics are normal the presence of a FLT3 mutation without a NPM1 mutation
•* Age \> 60 years
•* Antecedent hematological disorder (AHD)
•* AML that is considered to be therapy-related
•* FAB subtype M0 (minimally differentiated acute myeloblastic leukemia), M6 (acute erythroid leukemias, including erythroleukemia (M6a) and pure erythroid leukemia (M6b)), or M7 (acute megakaryoblastic leukemia)
•5. The patient is male or female, age 18 years or older
+13 more criteria

Exclusion Criteria

•1. The patient had a previous bone marrow or stem cell transplant
•2. The patient is seropositive for HIV 1, HIV 2, HBV, or HCV
•3. The patient has a psychiatric, addictive, neurological or other disorder that compromises the ability to give informed consent or comply with study requirements
•4. The patient is pregnant (confirmed by urine or serum pregnancy test) or lactating
•5. The patient has a recently diagnosed active malignancy requiring therapy
•6. The patient has an uncontrolled infection, or is receiving anti-fungal treatment for an ongoing infection
•7. The patient has known hypersensitivity to bovine proteins
•8. The patient has any condition that will place the patient at undue risk or discomfort as a result of adherence to study procedures
•9. The patient requires treatment with corticosteroids at a dose \> 0.1 mg/kg/day or has a known allergy to DSMO

Locations (4)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

University of Minnesota - Masonic Cancer Center

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Key Dates

Start Date

December 1, 2012

Primary Completion Date

March 1, 2016

Completion Date

February 1, 2018

Last Updated

June 29, 2017

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

CNDO-109-AANK Cells

BIOLOGICAL

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

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RECRUITINGPHASE2

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

NCT06220162

Acute Myeloid Leukemia

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RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CNDO-109-AANK for AML in First Complete Remission (CR1)

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias