Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia - Full Text View

Sponsor:	Masonic Cancer Center, University of Minnesota
Information provided by:	Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00005984

Purpose

RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.

Condition	Intervention	Phase
Leukemia	Drug: cyclophosphamide Drug: filgrastim Drug: recombinant interferon alfa Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Chronic Myeloid Leukemia Leukemia

Drug Information available for: Cyclophosphamide Interferon alfa-2a Filgrastim Lenograstim Granulocyte colony-stimulating factor Interferon alfa-n1 Interferons

U.S. FDA Resources

Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:

Time to hemopoietic recovery after transplantation [ Designated as safety issue: No ]
Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to initial hospital discharge [ Designated as safety issue: No ]
Peritransplantation toxicity [ Designated as safety issue: Yes ]
Quality of life at various time points [ Designated as safety issue: No ]
Cause of death [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	August 2000
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patients with CML Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML)	Drug: cyclophosphamide intravenously over 2 hours on day 1 and on days -7 and -6 Other Names: Endoxan Cytoxan Drug: filgrastim filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover Other Name: NEUPOGEN® Drug: recombinant interferon alfa Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression Other Name: INTRON® A Procedure: peripheral blood stem cell transplantation Patients receive the PBSC transplantation on day 0. Other Name: bone marrow transplant Procedure: radiation therapy total body irradiation twice a day on days -4 through -1 Other Name: irradiation

Arms

Assigned Interventions

Experimental: Patients with CML

Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML)

Drug: cyclophosphamide

intravenously over 2 hours on day 1 and on days -7 and -6

Other Names:

Endoxan
Cytoxan

Drug: filgrastim

filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover

Other Name: NEUPOGEN®

Drug: recombinant interferon alfa

Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression

Other Name: INTRON® A

Procedure: peripheral blood stem cell transplantation

Patients receive the PBSC transplantation on day 0.

Other Name: bone marrow transplant

Procedure: radiation therapy

total body irradiation twice a day on days -4 through -1

Other Name: irradiation

Detailed Description:

OBJECTIVES:

Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.

OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.

Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.

Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.

PROJECTED ACCRUAL: Not specified

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
- Philadelphia chromosome positive OR
- BCR/ABL rearrangement
Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols
70 and under
Performance status:
- Age 65-70 years:
- Karnofsky 80-100%
- Under 65 years:
- Karnofsky 90-100%
Renal:
- Age 65-70 years:
- Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
- Under 65 years:
- Not specified
Cardiovascular:
- Age 65-70 years:
- LVEF at least 45%
Pulmonary:
- Age 65-70 years:
- If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted
Normal organ function (excluding bone marrow)

Exclusion Criteria:

Blast crisis or post blast crisis
Severe fibrosis defined by bilateral trephine biopsies
Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005984

Locations

United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Study Chair:

Catherine M. Verfaillie, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Catherine Verfaille, MD, Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00005984 History of Changes
Other Study ID Numbers:	1996LS183, UMN-MT-1996-11
Study First Received:	July 5, 2000
Last Updated:	May 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:

chronic phase myelogenous leukemia
accelerated phase myelogenous leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Cyclophosphamide
Lenograstim
Antiviral Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on February 12, 2012