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| ID | Type | Description | Link |
|---|---|---|---|
| UMN-MT-1996-11 | Other Identifier | Blood and Marrow Transplantation Program |
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Study terminated as principal investigator [PI] left the university.
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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.
OBJECTIVES:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with CML | Experimental | Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | intravenously over 2 hours on day 1 and on days -7 and -6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to hemopoietic recovery after transplantation | ||
| Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples |
| Measure | Description | Time Frame |
|---|---|---|
| Time to initial hospital discharge | ||
| Peritransplantation toxicity | ||
| Quality of life at various time points |
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Inclusion Criteria:
Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols
70 and under
Performance status:
Renal:
Cardiovascular:
Pulmonary:
Normal organ function (excluding bone marrow)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine M. Verfaillie, MD | Masonic Cancer Center, University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
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| 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 |
|
|
| recombinant interferon alfa | Drug | Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression |
|
|
| peripheral blood stem cell transplantation | Procedure | Patients receive the PBSC transplantation on day 0. |
|
|
| radiation therapy | Procedure | total body irradiation twice a day on days -4 through -1 |
|
|
| Cause of death |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000069585 | Filgrastim |
| D016898 | Interferon-alpha |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D016026 | Bone Marrow Transplantation |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D016378 | Tissue Transplantation |
| D055585 | Physical Phenomena |
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