Study of Gelonin Purging of Autologous Stem Cells for Transplantation

NCT00043810 | Terminated Phase 1

• 1 other identifier: ID02-060
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Keywords

AML; MDS; Gelonin; Purging; Transplant; Peripheral Stem Cell

Outcome Measures

Primary Outcomes (1)

• Optimal Dose Gelonin

  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).

  28 days post transplant

Study Arms (1)

Gelonin Purging of ASCT

EXPERIMENTAL

Gelonin Purging of Autologous Stem Cells for Transplantation (ASCT) + Fludara/Busulfan

Procedure: Gelonin; Drug: Busulfan; Drug: Fludarabine

Interventions

Gelonin PROCEDURE

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.

Also known as: HuM195-Gelonin conjugate

Gelonin Purging of ASCT

Busulfan DRUG

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).

Also known as: Busulfex, Myleran

Gelonin Purging of ASCT

Fludarabine DRUG

40 mg/m2 in 100 ml of saline over one (1) hour on each of four (4) consecutive days (days - 6 to -3).

Also known as: Fludara, Fludarabine Phosphate

Gelonin Purging of ASCT

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Active CNS disease

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

GEL protein, Gelonium multiflorum; Busulfan; fludarabine; fludarabine phosphate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Sergio A. Giralt, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2002
• First Posted: August 15, 2002
• Study Start: July 1, 2002
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)