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.
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
Drug | Synonyms | Arms |
---|
Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion | NLA101, Dilanubicel | Treatment (Ex-vivo expanded cord blood progenitors) |
Cytarabine | | Treatment (Ex-vivo expanded cord blood progenitors) |
Filgrastim | | Treatment (Ex-vivo expanded cord blood progenitors) |
Fludarabine Phosphate | | Treatment (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
Name | Type | Description | Interventions |
---|
Treatment (Ex-vivo expanded cord blood progenitors) | Experimental | 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. | - 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. |
Last Updated
March 1, 2019