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Study of Gelonin Purging of Autologous Stem Cells for Transplantation

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ClinicalTrials.gov Identifier: NCT00043810
Recruitment Status : Terminated
First Posted : August 15, 2002
Last Update Posted : October 31, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Myelodysplastic Syndrome Procedure: Gelonin Drug: Busulfan Drug: Fludarabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Finding Study of Gelonin Purging of Autologous Stem Cells for Transplantation of Patients With AML/MDS in First or Subsequent Remission
Study Start Date : July 2002
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Arm Intervention/treatment
Experimental: Gelonin Purging of ASCT
Gelonin Purging of Autologous Stem Cells for Transplantation (ASCT) + Fludara/Busulfan
Procedure: Gelonin
Gelonin-AntiCD33 purging, 3 purging concentrations (fixed dose of 5 x 10^6 CD34+ cells/kg to be infused) with 3 dose levels of 1 nanomolar, 5.0 nanomolar and 10.0 nanomolar.
Other Name: HuM195-Gelonin conjugate

Drug: Busulfan
130 mg/m2 in normal saline over three (3) hours IV every twenty-four (24) hours for four (4) consecutive days (days -6 to -3).
Other Names:
  • Busulfex
  • Myleran

Drug: Fludarabine
40 mg/m2 in 100 ml of saline over one (1) hour on each of four (4) consecutive days (days - 6 to -3).
Other Names:
  • Fludara
  • Fludarabine Phosphate

Primary Outcome Measures :
  1. Optimal Dose Gelonin [ Time Frame: 28 days post transplant ]
    Dose-finding success, defined as patient alive and engrafted at day 28 post transplant, represented as number of patient successes with 3 differing doses (5, 10, or 15 nanomolar (nm) gelonin-antiCD33 purged autologous stem cells after a high dose fludarabine/busulfan conditioning regimen).

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion 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

Exclusion Criteria:

  • Active CNS disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043810

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Sergio A. Giralt, MD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00043810    
Other Study ID Numbers: ID02-060
First Posted: August 15, 2002    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Keywords provided by M.D. Anderson Cancer Center:
Peripheral Stem Cell
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Histologic Type
Fludarabine phosphate
GEL protein, Gelonium multiflorum
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Protein Synthesis Inhibitors
Enzyme Inhibitors