Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia

NCT00446173 | Withdrawn Phase 2 DMC

• 1 other identifier: 2003-0710
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: 1\. To study ex-vivo purging of autologous hematopoietic stem cells that will be used to support high-dose chemotherapy in patients with chronic myelogenous leukemia (CML). Major endpoints are neutrophil engraftment and survival. Secondary Objectives:

1. 1.To evaluate the toxicity of ex-vivo purged autologous cells when used to support high-dose chemotherapy.
2. 2.To evaluate the rate and duration of cytogenetic remissions achieved with this strategy.
3. 3.To determine the time to platelet recovery to 20,000/mm3.
4. 4.To determine the one-year survival rate.

Conditions

Leukemia

Keywords

Chronic Myelogenous Leukemia; Leukemia; Philadelphia (Ph) chromosome positive CML; Busulfan; Busulfex; Myleran; Cyclophosphamide; Cytoxan; Neosar; G-CSF; Filgrastim; Neupogen; GM-CSF; Sargramostim; Leukine

Outcome Measures

Primary Outcomes (2)

• Time to absolute neutrophil count (ANC) recovery to 500

  30 Days

• Survival Time

  30 Days (Success Rate + ANC Recovery to 500)

Study Arms (1)

Busulfan + Cyclophosphamide + G-CSF + GM-CSF

EXPERIMENTAL

Drug: Busulfan; Drug: Cyclophosphamide; Drug: G-CSF; Drug: GM-CSF

Interventions

Busulfan DRUG

130 mg/m\^2 IV Daily Over 3 Hours x 4 Days

Also known as: Bulsulfex, Myleran

Busulfan + Cyclophosphamide + G-CSF + GM-CSF

Cyclophosphamide DRUG

60 mg/kg IV Daily Over 4 Hours x 2 Days

Also known as: Cytoxan, Neosar

Busulfan + Cyclophosphamide + G-CSF + GM-CSF

G-CSF DRUG

10 mcg/kg Subcutaneously Once Daily

Also known as: Filgrastin, Neupogen

Busulfan + Cyclophosphamide + G-CSF + GM-CSF

GM-CSF DRUG

250 mcg/kg Subcutaneously Once Daily

Also known as: Sargramostim, Leukine

Busulfan + Cyclophosphamide + G-CSF + GM-CSF

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Philadelphia (Ph) chromosome positive CML \< age 65 and older than 21 years.
• Ph positive CML that is either in: 1. late 1st chronic phase (\> 2 years from diagnosis) 2. early chronic phase who did not achieve complete cytogenetic remission after one year on imatinib 3. beyond first chronic phase 4. accelerated phase 5. blastic phase that has responded to therapy (characterized by the presence of \< 10% bone marrow and/or circulating blasts at consent signing) 6. chronic phase, developing imatinib resistance (loss of molecular remission defined as at least a 1 log increase in the BCR-ABL/ABL ratio, in 2 time points at least 1 month apart, or loss of cytogenetic remission)
• Patients must have a Zubrod PS \< 3. Creatinine \< 1.8 mg/dl
• Serum bilirubin \</= 1.5 mg/dl
• Serum glutamate pyruvate transaminase (SGPT) \< 3 x normal values
• Patients with an HLA identical sibling are eligible if they refuse allogeneic transplantation, or if they are ineligible for allogeneic transplantation due to age.
• DLCO \>/= 50% of predicted
• Cardiac Ejection fraction \>/= 40%

You may not qualify if:

• Uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
• HIV positivity.
• Pregnant or lactating women.
• CML in blastic phase that has not responded to therapy given prior to enrollment in this study (characterized by the presence of more than 9% bone marrow and/or peripheral blood blasts at the time of consent signing)
• Hepatitis B or C virus infection. Hepatitis B infection defined by positive DNA test, positive E and / or surface antigen.
• CML in first molecular remission.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Busulfan; Cyclophosphamide; Granulocyte Colony-Stimulating Factor; Filgrastim; Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; 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

Study Officials

• Marcos de Lima, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 12, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

US (1)