Clinical trial · Interventional
Disrupting the Bone Marrow Microenvironment With G-CSF in Acute Lymphoblastic Leukemia
A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT01331590CI-TRIAL-00023936completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- G-CSF + Ifosfamide + Etoposide + Dexamethasone + Mesna
- description
- 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.
- interventionNames
- Drug: G-CSF
- Drug: Ifosfamide
- Drug: Etoposide
- Drug: Dexamethasone
- Drug: Mesna
Primary outcomes (2)
- measure
- Treatment-related mortality
- timeFrame
- 30 days after start of treatment
- measure
- Delayed hematologic recovery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.