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Expanded Cord Blood Cell Infusion Following Combination Chemotherapy in Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01701323
Recruitment Status : Terminated
First Posted : October 5, 2012
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Nohla Therapeutics, Inc.

Brief Summary:
This pilot clinical trial studies infusion of expanded cord blood hematopoietic progenitor cells following combination chemotherapy in treating younger patients with acute myeloid leukemia that has relapsed or has not responded to treatment. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemotherapy also kills healthy infection-fighting cells, increasing the risk of infection. The infusion of expanded cord blood hematopoietic progenitor cells may be able to replace blood-forming cells that were destroyed by chemotherapy. This cellular therapy may decrease the risk of infection following chemotherapy.

Condition or disease Intervention/treatment Phase
Acute Leukemia of Ambiguous Lineage Acute Myeloid Leukemia Biological: Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion Drug: Cytarabine Drug: Filgrastim Drug: Fludarabine Phosphate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Chemotherapy (FLAG) in Patients With AML or Acute Leukemia of Ambiguous Lineage
Actual Study Start Date : December 10, 2012
Actual Primary Completion Date : May 10, 2018
Actual Study Completion Date : May 10, 2018


Arm Intervention/treatment
Experimental: Treatment (Ex-vivo expanded cord blood progenitors)
Patients receive filgrastim SC or IV on days 1-7, fludarabine phosphate IV QD over 30 minutes on days 2-6, cytarabine IV QD over 4 hours on days 2-6, and ex-vivo expanded cord blood progenitor cells IV over 30 minutes on day 8.
Biological: Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion
Given IV
Other Names:
  • NLA101
  • Dilanubicel

Drug: Cytarabine
Given IV

Drug: Filgrastim
Given SC or IV

Drug: Fludarabine Phosphate
Given IV




Primary Outcome Measures :
  1. Incidence of NCI CTCAE grade > 3 infusional toxicities [ Time Frame: Up to 2 years ]
  2. Occurrence of transfusion associated graft versus host disease [ Time Frame: Up to 2 years ]
  3. Incidence of platelet refractoriness in the presence of alloimmunization as a direct result of ex vivo expanded cord blood product infusion [ Time Frame: Up to 2 years ]
  4. Incidence of delayed marrow recovery [ Time Frame: Up to day 42 ]
    Failure to achieve ANC >= 500 cells/µl by day 42 post treatment with marrow cellularity < 5% and marrow blast count < 5%.

  5. Rate of treatment related mortality [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Time to neutrophil recovery [ Time Frame: Up to 2 years ]
    ANC >= 100 cells/ul and 500 cells/ul

  2. In vivo persistence of ex vivo expanded cellular therapy [ Time Frame: Up to 2 years ]
    Assessed by peripheral blood cell sorted deoxyribonucleic acid (DNA) chimerisms of the cluster of differentiation myeloid and lymphoid cell lineages as well as whole marrow chimerisms.

  3. Patient and infused expanded cord blood cells immune interaction [ Time Frame: Up to 2 years ]
    Assessed by performing host-donor studies.

  4. Incidence of NCI CTCAE grade 3 or 4 infections [ Time Frame: First 30 days following FLAG administration ]
  5. Incidence of NCI CTCAE grade > 3 chemotherapy-related toxicity in the first 30 days following fludarabine phosphate, cytarabine, and filgrastim (FLAG) therapy [ Time Frame: First 30 days following FLAG administration ]
  6. Rate of complete remission [ Time Frame: Up to 2 years ]
  7. Leukemia-free survival [ Time Frame: Up to 2 years ]
  8. Overall survival [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   6 Months to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a diagnosis of AML or acute leukemia of ambiguous lineage according to World Health Organization (WHO) classification with >= 5% of disease in bone marrow (BM)
  • Recipients of prior allogeneic hematopoietic stem cell transplantation for AML or acute leukemia of ambiguous lineage are eligible if they do not have graft-versus-host disease (GVHD) or they have quiescent GVHD whether or not they are receiving immunosuppressive therapy
  • Must have a Lansky or Karnofsky performance status of >= 50; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients must have recovered from the acute toxicity of all prior chemotherapy
  • The following amounts of time must have elapsed prior to entry on study:

    • 2 weeks from local radiation therapy (XRT)
    • 8 weeks from prior craniospinal or if > 50% of the pelvis has been irradiated
    • 6 weeks must have elapsed if other bone marrow radiation has occurred
  • Adequate cardiac, renal, pulmonary, and hepatic function
  • Patient must have a life expectancy of at least 2 months
  • Females of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Females of childbearing potential and males should agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation

Exclusion Criteria:

  • Recipients of prior allogeneic hematopoietic stem cell transplant (HSCT) with active acute or chronic GVHD
  • Patients with history of Down's syndrome, Fanconi anemia or other known marrow failure condition
  • Patients currently receiving other investigational drugs are not eligible
  • Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol with the exception of intrathecal chemotherapy; this includes the tyrosine kinase inhibitor sorafenib which must not be initiated until patient demonstrates count recovery
  • Patients with a systemic fungal, bacterial, viral, or other infection not controlled despite appropriate antibiotics or other treatment; uncontrolled systemic infections require infectious disease consultation for verification
  • Patients who are platelet refractory prior to initiation of protocol therapy
  • Pregnant or lactating patients
  • Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results

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): NCT01701323


Locations
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United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Nohla Therapeutics, Inc.
National Cancer Institute (NCI)
Fred Hutchinson Cancer Research Center
Investigators
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Principal Investigator: Ann Dahlberg Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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Responsible Party: Nohla Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01701323     History of Changes
Other Study ID Numbers: 2584
NCI-2012-01724 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2584
2584.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Fludarabine
Fludarabine phosphate
Lenograstim
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic