An Early Phase 1 interventional study of G-CSF and Ifosfamide in Precursor Cell Lymphoblastic Leukemia-Lymphoma, sponsored by Washington University School of Medicine. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-20.
Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Treatment
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).
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.
5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 13 is below the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Adequate organ function defined as:
Exclusion Criteria:
G-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.
Drug: G-CSF · Drug: Ifosfamide · Drug: Etoposide · Drug: Dexamethasone · Drug: Mesna
Also known as: Filgrastim, Neupogen, Granulocyte Colony-Stimulating Factor, Recombinant Methionyl Human G-CSF
Also known as: Ifex, Isophosphamide
Also known as: Etopophos, VP-16
Also known as: Decadron
Also known as: Mesnex
Treatment-related mortality
Time frame: 30 days after start of treatment
Delayed hematologic recovery
Defined as neutrophil recovery (ANC \> 1,000/mm3) \> 42 days after the start of chemotherapy in the absence of persistent leukemia
Time frame: Day 46 of treatment
Complete remission rate cytogenetic complete remission
Time frame: 42 days
Overall survival
Every 6 months
Time frame: 2 years
Disease-free survival
Every 6 months
Time frame: 2 years
Remission duration
Every 6 months
Time frame: 2 years
Frequency and severity of adverse events
Time frame: 30 days post treatment
Interaction of pretreatment disease and patient characteristics on clinical outcomes
Morphology, cytogenetics, immunophenotype, WBC, and performance status
Time frame: Baseline
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine