Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia

NCT00005984 | Terminated Phase 2 DMC

• 2 other identifiers: 1996LS183UMN-MT-1996-11
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia

Keywords

chronic phase myelogenous leukemia; accelerated phase myelogenous leukemia

Outcome Measures

Primary Outcomes (2)

• Time to hemopoietic recovery after transplantation

• Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples

Secondary Outcomes (4)

• Time to initial hospital discharge

• Peritransplantation toxicity

• Quality of life at various time points

• Cause of death

Study Arms (1)

Patients with CML

EXPERIMENTAL

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

Drug: cyclophosphamide; Drug: filgrastim; Drug: recombinant interferon alfa; Procedure: peripheral blood stem cell transplantation; Procedure: radiation therapy

Interventions

cyclophosphamide DRUG

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

Also known as: Endoxan, Cytoxan

Patients with CML

filgrastim DRUG

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

Also known as: NEUPOGEN®

Patients with CML

recombinant interferon alfa DRUG

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

Also known as: INTRON® A

Patients with CML

peripheral blood stem cell transplantation PROCEDURE

Patients receive the PBSC transplantation on day 0.

Also known as: bone marrow transplant

Patients with CML

radiation therapy PROCEDURE

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

Also known as: irradiation

Patients with CML

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Chronic-Phase

Interventions

Cyclophosphamide; Filgrastim; Interferon-alpha; Peripheral Blood Stem Cell Transplantation; Bone Marrow Transplantation; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interferon Type I; Interferons; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Tissue Transplantation; Physical Phenomena

Study Officials

• Catherine M. Verfaillie, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: November 29, 2017

Record last verified: 2017-09

Locations

US (1)