AzTrials
AzTrials

Acute Leukemia of Ambiguous LineagePhase 1NCT01701323

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

A Phase 1 study testing Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion, Cytarabine and Filgrastim in people with Acute Leukemia of Ambiguous Lineage and Acute Myeloid Leukemia, run by Nohla Therapeutics, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 months to 30 years
What is being tested?
Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion, Cytarabine and Filgrastim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesUnited States
Study dates
10 Dec 2012to 10 May 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

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

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.

Being tested
Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion, Cytarabine, Filgrastim, Fludarabine Phosphate
Medical subject headings
Leukemia, Biphenotypic, Acute, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01701323
Study groupRoleWhat they receive
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.
Receives: Biological: Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion; Drug: Cytarabine; Drug: Filgrastim; Drug: Fludarabine Phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of NCI CTCAE grade > 3 infusional toxicities

    Measured: Up to 2 years

  2. Occurrence of transfusion associated graft versus host disease

    Measured: 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

    Measured: Up to 2 years

  4. Incidence of delayed marrow recovery

    Failure to achieve ANC >= 500 cells/µl by day 42 post treatment with marrow cellularity < 5% and marrow blast count < 5%.

    Measured: Up to day 42

  5. Rate of treatment related mortality

    Measured: Up to 2 years

Secondary outcomes (8)

  1. Time to neutrophil recovery

    ANC >= 100 cells/ul and 500 cells/ul

    Measured: Up to 2 years

  2. In vivo persistence of ex vivo expanded cellular therapy

    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.

    Measured: Up to 2 years

  3. Patient and infused expanded cord blood cells immune interaction

    Assessed by performing host-donor studies.

    Measured: Up to 2 years

  4. Incidence of NCI CTCAE grade 3 or 4 infections

    Measured: 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

    Measured: First 30 days following FLAG administration

  6. Rate of complete remission

    Measured: Up to 2 years

  7. Leukemia-free survival

    Measured: Up to 2 years

  8. Overall survival

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2012 (estimated)
  2. Study start10 Dec 2012
  3. Primary completion10 May 2018
  4. Study completion10 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701323
Sponsor's protocol ID
2584
Other IDs
NCI-2012-01724, 2584, 2584.00, P30CA015704
Status last verified
Feb 2019
First submitted
3 Oct 2012
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion, Cytarabine and Filgrastim in people with Acute Leukemia of Ambiguous Lineage and Acute Myeloid Leukemia, run by Nohla Therapeutics, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of NCI CTCAE grade > 3 infusional toxicities (time frame: Up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01701323.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in