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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520558
First Posted: January 30, 2012
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Coronado Biosciences, Inc.
  Purpose
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.

Condition Intervention Phase
Acute Myeloid Leukemia Biological: CNDO-109-AANK Cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Coronado Biosciences, Inc.:

Primary Outcome Measures:
  • Define MTD [ Time Frame: up to 30 days post dose ]
    The primary objective is to define the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of CNDO-109-Activated Allogeneic Natural Killer Cells infused after preparative chemotherapy, administered to patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1) at the time of enrollment and are considered to be at high risk for recurrence. The MTD outcome measure is presented as number of participants with DLTs.


Secondary Outcome Measures:
  • Additional Safety Profile Beyond MTD [ Time Frame: up to 360 days post dose ]
    Characterize the safety profile of CNDO-109-Activated Allogeneic Natural Killer Cells infusion after preparative therapy by measurement of adverse events, safety labs, vital signs, bone marrow biopsy/aspiration and physical examination.

  • Efficacy [ Time Frame: from the date of documented CR until the first documented progression date or until day 360 post dose whichever is sooner ]
    Determine relapse free survival (RFS) and overall survival (OS) following infusion with CNDO-109-Activated Allogeneic Natural Killer Cells.


Enrollment: 12
Study Start Date: December 2012
Estimated Study Completion Date: February 2018
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNDO-109-AANK Cells Dose 1
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
Biological: CNDO-109-AANK Cells
Single dose, infusion
Other Name: CNDO-109-Activated Allogeneic Natural Killer Cells
Experimental: CNDO-109-AANK Cells Dose 2
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
Biological: CNDO-109-AANK Cells
Single dose, infusion
Other Name: CNDO-109-Activated Allogeneic Natural Killer Cells
Experimental: CNDO-109-AANK Cells Dose 3
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
Biological: CNDO-109-AANK Cells
Single dose, infusion
Other Name: CNDO-109-Activated Allogeneic Natural Killer Cells

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  6. The patient has an ECOG performance status of 0, 1, or 2
  7. The patient has an available NK cell donor who is a HLA haploidentical first-degree (parent, child, or sibling) or second-degree (child of a sibling) relative; minimum testing will be for HLA-A, HLA-B, and HLA-DR with donors matched for 3/6, 4/6 or 5/6 antigens
  8. The patient has an absence of coexisting medical problems that would significantly increase the risk of the chemotherapy procedure (e.g. poor left ventricular ejection fraction [LVEF<40%])
  9. The patient has recovered from reversible toxicity from prior therapy. Permanent and stable side effects or changes are acceptable if ≤ Grade 1 (CTCAE, v4.03)
  10. The patient has serum creatinine <2×ULN and not rising for at least 2-4 weeks before chemotherapy. If elevated, the 24-hour creatinine clearance must be >50 mL/min
  11. The patient has serum total bilirubin < 2 g/dL (unless the patient has a diagnosis of Gilbert's disease), SGOT (ALT) <3.5×ULN, and SGPT (AST) <3.5×ULN
  12. The patient has an absolute neutrophil count (ANC) ≥1000/µL, platelets ≥100,000/µL and is not transfusion dependent for platelets and/or red cells
  13. The patient has LVEF ≥40% by ECHO or MUGA scan and no clinically significant abnormalities in 12-lead ECG
  14. The patient has a PT (or INR) and PTT up to 1.25×ULN
  15. The patient must not be dependent on supplemental oxygen
  16. The patient is using an effective contraceptive (per the institutional standard), if procreative potential exists
  17. The patient must be willing and able to comply with all study protocol requirements. The patient or a legally authorized representative must fully understand all elements of the informed consent and have signed the informed consent according to institutional and federal regulatory requirements
  18. The patient has not received an investigational chemotherapy within the last 28 days prior to the screening visit and has never received investigational immunotherapy. In addition, the patient must not receive treatment for AML (including treatment with IL-2 or IFNγ) in the interval of time between the screening visit and initiation of pre-infusion preparative therapy

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520558


Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Minnesota
University of Minnesota - Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Coronado Biosciences, Inc.
  More Information

Responsible Party: Coronado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01520558     History of Changes
Other Study ID Numbers: CNDO109-001
First Submitted: January 24, 2012
First Posted: January 30, 2012
Results First Submitted: April 18, 2017
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017
Last Verified: April 2017

Keywords provided by Coronado Biosciences, Inc.:
Acute Myeloid Leukemia
High Risk Relapse
Complete Remission
Allogeneic Natural Killer Cells

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms