Study of Gelonin Purging of Autologous Stem Cells for Transplantation - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00043810

Purpose

Patients with Acute Myelogenous Leukemia or Myelodysplastic are able to achieve a complete remission but fail to achieve a prolonged disease-free survival. High dose chemotherapy and autologous bone marrow transplantation has been shown to be effective in this group of patients but hematopoietic recovery is slow, and infectious or bleeding complications are common. The delay in hematopoietic recover is accentuated by the use of purging techniques. This is a novel purging approach for autologous stem cell transplantation in patients with Acute Myelogenous Leukemia or Myelodysplastic syndrome to allow for rapid engraftment with a lower relapse rate therefore improving the therapeutic outcomes

Condition	Intervention	Phase
Acute Myelogenous Leukemia Myelodysplastic Syndrome	Procedure: gelonin for purging autologous stem cells	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Dose Finding Study of Gelonin Purging of Autologous Stem Cells for Transplantation of Patients With AML/MDS in First or Subsequent Remission

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	24
Study Start Date:	July 2002

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with AML, RAEB-t, RAEB, or CMML who are in first remission and have poor prognosis cytogenetic abnormalities (i.e: deletions of chromosome 5, 7, 20; trisomy 8, t9,22,11q23 abnormalities or complex karyotypes).*
Patients with AML, RAEB-t, RAEB, or CMML who are in second or subsequent remission.
Remission is defined as ANC>1.5 x 109/Lt; Platelet count >100 x 109/Lt, and red cell transfusion independence.
Male or female who have provided written informed consent.
Tumor cells must be > 80 % CD-33 positive by flow cytometry.
For women of childbearing potential (i.e., exclude post-menopausal women, women who have been surgically sterilized), adequate birth control methods must be used. Acceptable birth control methods are limited to oral contraceptives, implants, diaphragm, IUD or spermicide used with a condom)
No chemotherapy for the two weeks prior to entering the study.
No evidence of residual toxic effects from prior chemotherapy.
Patients with proven bacterial infection are not eligible until resolution of the infection (patient afebrile, not on steroids). Patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and they do not have fever exceeding 38C.
Must have at least 5 x 106 CD34+ peripheral blood stem cells collected.
All patients who have had less than 7 x 106 CD34+ cells/kg collected, should have a bone marrow harvest to serve as back-up.
A minimum of 1 x 106 CD34+ cells/kg of unpurged bone marrow or 2 x 106 CD34+ cells/kg of unpurged peripheral blood need to be stored as backup to be eligible for this protocol.
Patients must have bilirubin less than 2.0, transaminases less than 4 x upper limit of normal.
Pulmonary function tests >50% predicted for DLCO, FVC and FEV1
No active uncontrolled infection
No active CNS disease
No uncontrolled arrythmias
Zubrod Performance Status less than or equal to 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043810

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

More Information

No publications provided

Study ID Numbers:	ID02-060
Study First Received:	August 14, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00043810 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

AML
MDS
Gelonin

Purging
Transplant
Peripheral Stem Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Antineoplastic Agents
Hematologic Diseases
Myelodysplastic Syndromes
Enzyme Inhibitors
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Pharmacologic Actions

Protein Synthesis Inhibitors
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
GEL protein, Gelonium multiflorum
Bone Marrow Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 22, 2009