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

NCT01701323

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 2584
  • SECONDARY ID: NCI-2012-01724
  • SECONDARY ID: 2584
  • SECONDARY ID: 2584.00
  • SECONDARY ID: P30CA015704
  • NCT ID: NCT01701323

Conditions

  • Acute Leukemia of Ambiguous Lineage
  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
Ex-Vivo Expanded Cord Blood Progenitor Cell InfusionNLA101, DilanubicelTreatment (Ex-vivo expanded cord blood progenitors)
CytarabineTreatment (Ex-vivo expanded cord blood progenitors)
FilgrastimTreatment (Ex-vivo expanded cord blood progenitors)
Fludarabine PhosphateTreatment (Ex-vivo expanded cord blood progenitors)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Treatment (Ex-vivo expanded cord blood progenitors)ExperimentalPatients 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.
  • Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion
  • Cytarabine
  • Filgrastim
  • Fludarabine Phosphate

Eligibility 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
      
Maximum Eligible Age:30 Years
Minimum Eligible Age:6 Months
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of NCI CTCAE grade > 3 infusional toxicities
Time Frame:Up to 2 years
Safety Issue:
Description:Failure to achieve ANC >= 500 cells/µl by day 42 post treatment with marrow cellularity < 5% and marrow blast count < 5%.

Secondary Outcome Measures

Measure:Time to neutrophil recovery
Time Frame:Up to 2 years
Safety Issue:
Description:ANC >= 100 cells/ul and 500 cells/ul
Measure:In vivo persistence of ex vivo expanded cellular therapy
Time Frame:Up to 2 years
Safety Issue:
Description: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.
Measure:Patient and infused expanded cord blood cells immune interaction
Time Frame:Up to 2 years
Safety Issue:
Description:Assessed by performing host-donor studies.
Measure:Incidence of NCI CTCAE grade 3 or 4 infections
Time Frame:First 30 days following FLAG administration
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Rate of complete remission
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Leukemia-free survival
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Nohla Therapeutics, Inc.

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