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Trial record 1 of 1 for:    NCT00038805
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Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML) and Myelodysplastic Syndrome (MDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038805
Recruitment Status : Terminated
First Posted : June 7, 2002
Last Update Posted : October 31, 2018
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE June 5, 2002
First Posted Date  ICMJE June 7, 2002
Last Update Posted Date October 31, 2018
Study Start Date  ICMJE May 2001
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2010)
Maximum Tolerated Dose (MTD) of CMA-676 [ Time Frame: Continual Reassessment Method (CRM); each cycle ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML) and Myelodysplastic Syndrome (MDS)
Official Title  ICMJE Allogeneic Stem Cell Transplantation Using Mylotarg (CMA-676) Plus Nonmyeloablative Chemotherapy in Older or Medically Infirm Patients With High-Risk Acute Leukemia (ALL), Chronic Myelogenous Leukemia (CML) or Myelodysplastic Syndrome (MDS)
Brief Summary

Primary Objective:

To determine the safety and maximum tolerated dose of CMA-676 as part of an intensive but nonmyeloablative preparative regimen in older or medically infirm patients undergoing mini-allogeneic peripheral blood stem cell transplantation

Secondary Objectives:

  1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy.
  2. To evaluate disease-free and overall survival and relapse rates.
  3. To evaluate the need and ability to give multiple cycles of Mylotarg plus FA and mobilized DLI in patients not achieving complete remission.
Detailed Description

Mylotarg is a novel immunoconjugate directed against the CD33 antigen found on most leukemia cells. This humanized murine IgG4 monoclonal antibody is tagged with the toxin, calicheamicin. In equal molar concentrations, calicheamicin is about 3200 times more potent than adriamycin. In a Phase I study involving adult patients with relapse AML, Mylotarg has been shown to have significant anti-leukemia activity with little toxicity. The most concerning side effects of Mylotarg were prolonged neutropenia and thrombocytopenia. Phase II studies have also demonstrated good efficacy with little toxicity.

The goal of this proposal is to include Mylotarg in a nonmyeloablative preparative regimen similar to FAI used at MD Anderson Cancer Center. The hypothesis is that Mylotarg will provide potent anti-leukemic effects without adding toxicity to the mini-allogeneic bone marrow transplant regimen. A more potent anti-leukemic response may increase the complete remission rates and induce a state of minimal residual disease (MRD). Therefore, the Graft vs. Leukemia (GVL) effect of allogeneic transplantation will have a better chance for success. In addition, the administration of donor cells after Mylotarg should ameliorate the cytopenias previously associated with Mylotarg. This medication likely will be well-tolerated.

Patients with high-risk hematopoietic malignancies that express CD33 (i.e. AML, ALL, CML and MDS) will be included. We will enroll older patients (>55 years old) or medically infirm patients who are unable to tolerate standard allogeneic bone marrow transplant. Patients will be evaluated at 28 days post-transplant for evidence of response. Those with residual disease may be eligible for additional Mylotarg given together with donor lymphocyte infusions. Additional courses of Mylotarg may improve overall survival in this poor prognosis group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia
Intervention  ICMJE Drug: Mylotarg
Other Name: CMA-676
Study Arms  ICMJE Experimental: Mylotarg
Intervention: Drug: Mylotarg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 25, 2010)
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients 12-75 years of age
  • Patients are eligible if deemed ineligible for conventional high dose chemotherapy programs because of concurrent medical conditions. Patients with refractory AML are eligible provided ejection fraction >= 35%; FEV1, FVC, or DLCO >= 40%; GPT < 3 x normal, direct bilirubin < 2.
  • Patients must have recovered from previous Grade III-IV toxicity due to prior antineoplastic therapy (except alopecia).
  • Patients with AML with induction failure, relapse or 2nd remission
  • Patients with MDS with IPI INT-2 or High-risk disease or CMML.
  • Patients with CML in accelerated phase or blast crisis
  • Patients with ALL with induction failure, relapse or 2nd remission
  • Patients receiving prior BMT are eligible. If myeloablative chemoradiotherapy was used in the prior transplant patients must be >90 days from transplant. If non-myeloablative therapy was used patients must be >30 days post-transplant.
  • Leukemia cells must express cell surface CD33 evaluated by flow cytometry in > 20% of leukemia cells.
  • Patients must have an HLA identical related donor capable of donating G-CSF stimulated peripheral blood stem cells using apheresis techniques. If patient has a contraindication to PBSC collection bone marrow can be used.
  • Patients must have a Zubrod PS <2, Cr <2.0, direct bilirubin <2, and transaminases SGPT <3x normal
  • Patients must have an estimated life expectancy > 3 months
  • Patient and donor must sign informed consent

Exclusion Criteria:

  • no uncontrolled active infection
  • no HIV disease
  • no pregnancy and no nursing
  • no active, uncontrolled CNS leukemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00038805
Other Study ID Numbers  ICMJE ID00-153
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Marcos de Lima, MD UT MD Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP