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)

NCT00038805 | Terminated Phase 2

• 1 other identifier: ID00-153
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Leukemia

Keywords

High Risk Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Chronic Myeloid Leukemia; Myelodysplastic Syndrome; ALL; AML; MDS; CML; CMML; Nonmyeloablative Preparative Regimen; Mylotarg; CMA-676

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of CMA-676

  Continual Reassessment Method (CRM); each cycle

Study Arms (1)

Mylotarg

EXPERIMENTAL

Drug: Mylotarg

Interventions

Mylotarg DRUG

Also known as: CMA-676

Mylotarg

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• no uncontrolled active infection
• no HIV disease
• no pregnancy and no nursing
• no active, uncontrolled CNS leukemia

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

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; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Marcos de Lima, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2002
• First Posted: June 7, 2002
• Study Start: May 1, 2001
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)