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Precursor Cell Lymphoblastic Leukemia-LymphomaEarly Phase 1NCT01331590

Disrupting the Bone Marrow Microenvironment With G-CSF in Acute Lymphoblastic Leukemia

A Early Phase 1 study testing G-CSF, Ifosfamide and Etoposide in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Washington University School of Medicine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the ability of G-CSF to disrupt the bone marrow microenvironment as a means to increase the efficacy of chemotherapy in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
G-CSF, Ifosfamide and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesUnited States
Study dates
Jul 2011to Nov 2015
Phase
Early 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute lymphoblastic leukemia diagnosed according to WHO criteria (>25% lymphoblasts in BM) which is relapsed or refractory to therapy. Patients with t(9;22) must be refractory to BCR-ABL tyrosine kinase inhibitors.
  • Age ≥ 18 years
  • ECOG performance status ≤ 3.
  • Adequate organ function defined as:
  • Calculated creatinine clearance ≥ 50 ml/min
  • AST, ALT, total bilirubin ≤ 2 x institutional ULN except when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia)
  • Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study.
  • Able to provide signed informed consent prior to registration on study.

Who cannot join

  • Previous salvage chemotherapy with ifosfamide and etoposide
  • Pregnant or nursing
  • Received any other investigational agent or cytotoxic chemotherapy within the preceding 2 weeks
  • Received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study
  • Severe concurrent illness that would limit compliance with study requirements

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Relapsed or Refractory Acute Lymphoblastic Leukemia

The purpose of this study is to determine the ability of G-CSF to disrupt the bone marrow microenvironment as a means to increase the efficacy of chemotherapy in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

Read the detailed description

In this study, we will combine G-CSF as priming prior to and during the administration of salvage chemotherapy regimen in ALL. Abundant data suggests that leukemic cells receive key growth and survival signals from the bone marrow microenvironment. Our preclinical data show that 4-5 days of G-CSF treatment is associated with a loss of osteoblasts and decreases expression of key chemokine/ cytokines which support lymphocyte development. The investigators hypothesize that G-CSF will disrupt the protective effects of the bone marrow microenvironment and augment the effect of chemotherapy in adults with ALL. This is a pilot study of G-CSF priming in adult patients with relapsed or refractory ALL to determine the feasibility and to characterize the effect of G-CSF treatment on the marrow microenvironment.

Being tested
G-CSF, Ifosfamide, Etoposide, Dexamethasone, Mesna
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • G-CSFDrug

    Also called Filgrastim, Neupogen, Granulocyte Colony-Stimulating Factor, Recombinant Methionyl Human G-CSF

  • IfosfamideDrug

    Also called Ifex, Isophosphamide

  • EtoposideDrug

    Also called Etopophos, VP-16

  • DexamethasoneDrug

    Also called Decadron

  • MesnaDrug

    Also called Mesnex

Study groups in NCT01331590
Study groupRoleWhat they receive
G-CSF + Ifosfamide + Etoposide + Dexamethasone + MesnaExperimentalG-CSF = 10 mcg/kg/d SQ starting on day 1 and continuing until ANC >=1000/mcL x 2 days Ifosfamide = 3330 mg/m2/d CIVI over 24 hours on Days 4-6 Etoposide = 150 mg/m2 IV over 2 hours BID on Days 4-6 Dexamethasone = 5 mg/m2 PO or IV BID on Days 4-10 Mesna = 2660 mg/m2/d continuous IV infusion over 24 hours on Days 4-6. 2000 mg/m2 continuous IV infusion over 12 hours on Day 7 to be started immediately after completion of ifosfamide.
Receives: Drug: G-CSF; Drug: Ifosfamide; Drug: Etoposide; Drug: Dexamethasone; Drug: Mesna

What is being measured

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

  1. Treatment-related mortality

    Measured: 30 days after start of treatment

  2. Delayed hematologic recovery

    Defined as neutrophil recovery (ANC > 1,000/mm3) > 42 days after the start of chemotherapy in the absence of persistent leukemia

    Measured: Day 46 of treatment

Secondary outcomes (6)

  1. Complete remission rate cytogenetic complete remission

    Measured: 42 days

  2. Overall survival

    Every 6 months

    Measured: 2 years

  3. Disease-free survival

    Every 6 months

    Measured: 2 years

  4. Remission duration

    Every 6 months

    Measured: 2 years

  5. Frequency and severity of adverse events

    Measured: 30 days post treatment

  6. Interaction of pretreatment disease and patient characteristics on clinical outcomes

    Morphology, cytogenetics, immunophenotype, WBC, and performance status

    Measured: Baseline

Timeline

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

  1. First posted8 Apr 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionOct 2014
  4. Study completionNov 2015

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01331590
Sponsor's protocol ID
201104323
Status last verified
Sep 2016
First submitted
31 Mar 2011
Last updated
20 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing G-CSF, Ifosfamide and Etoposide in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Washington University School of Medicine 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 20 Sep 2016. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Treatment-related mortality (time frame: 30 days after start of treatment). The study lists 2 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 NCT01331590.

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 20 Sep 2016.

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