Trial record 1 of 1 for:
NCT01331590
Disrupting the Bone Marrow Microenvironment With G-CSF in Acute Lymphoblastic Leukemia
This study is currently recruiting participants.
Verified March 2013 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01331590
First received: March 31, 2011
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Drug: G-CSF Drug: Ifosfamide Drug: Etoposide Drug: Dexamethasone Drug: Mesna |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Relapsed or Refractory Acute Lymphoblastic Leukemia |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Ifosfamide
Mesna
Etoposide
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- Treatment-related mortality [ Time Frame: 30 days after start of treatment ] [ Designated as safety issue: Yes ]
- Delayed hematologic recovery [ Time Frame: Day 46 of treatment ] [ Designated as safety issue: Yes ]Defined as neutrophil recovery (ANC > 1,000/mm3) > 42 days after the start of chemotherapy in the absence of persistent leukemia
Secondary Outcome Measures:
- Complete remission rate cytogenetic complete remission [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Every 6 months
- Disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Every 6 months
- Remission duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]Every 6 months
- Frequency and severity of adverse events [ Time Frame: 30 days post treatment ] [ Designated as safety issue: Yes ]
- Interaction of pretreatment disease and patient characteristics on clinical outcomes [ Time Frame: Baseline ] [ Designated as safety issue: No ]Morphology, cytogenetics, immunophenotype, WBC, and performance status
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: G-CSF + Ifosfamide + Etoposide + Dexamethasone + Mesna
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
Other Names:
Drug: Ifosfamide
Other Names:
Drug: Etoposide
Other Names:
Drug: Dexamethasone
Other Name: Decadron
Drug: Mesna
Other Name: Mesnex
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- Active CNS involvement with leukemia
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331590
Contacts
| Contact: Geoffrey L. Uy, M.D. | 314-454-8304 | guy@dom.wustl.edu |
Locations
| United States, Illinois | |
| University of Chicago Medical Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Wendy Stock, M.D. 773-834-8982 wstock@medicine.bsd.uchicago.edu | |
| Principal Investigator: Wendy Stock, M.D. | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Geoffrey Uy, M.D. 314-454-8304 guy@dom.wustl.edu | |
| Sub-Investigator: Daniel Link, M.D. | |
| Sub-Investigator: John DiPersio, M.D., Ph.D. | |
| Sub-Investigator: Peter Westervelt, M.D., Ph.D. | |
| Sub-Investigator: Camille Abboud, M.D. | |
| Sub-Investigator: Amanda Cashen, M.D. | |
| Sub-Investigator: Timothy Graubert, M.D. | |
| Sub-Investigator: Keith Stockerl-Goldstein, M.D. | |
| Sub-Investigator: Michael Tomasson, M.D. | |
| Sub-Investigator: Todd Fehniger, M.D., Ph.D. | |
| Sub-Investigator: Mark Schroeder, M.D. | |
| Sub-Investigator: Matthew Walter, M.D. | |
| Sub-Investigator: Kenneth Carson, M.D. | |
| Sub-Investigator: Stephanie Bauer, RN MSN FNP | |
| Sub-Investigator: Anne Lehrer, RN MSN ACNP | |
| Sub-Investigator: Maggie Kavanaugh, RN MSN ANP | |
| Sub-Investigator: Jeane Kuensting, RN MS ANP | |
| Sub-Investigator: Holly Comer, RN MSN ANP | |
| Sub-Investigator: Sarah McCammon, RN MSN FNP | |
| Sub-Investigator: Ravi Vij, M.D. | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | Geoffrey Uy, M.D. | Washington University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01331590 History of Changes |
| Other Study ID Numbers: | 201104323 |
| Study First Received: | March 31, 2011 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Mesna Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Etoposide phosphate |
Isophosphamide mustard Etoposide Ifosfamide BB 1101 Lenograstim Protective Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013