Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)

NCT00822094 | Completed Phase 2 Results

• 1 other identifier: CLTR0308-205
• Study Type: interventional
• Target: 126
• Locations: 4 countries
• Sites: 42

Brief Summary

The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens. The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.

Conditions

Acute Myeloid Leukemia

Keywords

Acute; Myeloid; Leukemia; Adult; First; Relapse; AML; Acute Myelogenous leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Acute myelocytic leukemia

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Surviving at 1 Year

  The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.

  Up to 1 year from randomization

Secondary Outcomes (5)

• Complete Remission Rate

  Following 1st induction, following 2nd induction if applicable

• Event Free Survival

  Up to 1 year from randomization

• Remission Duration

  Following achievement of CR and up to 1 year from randomization

• Rate of Aplasia

  Up to 1 year from randomization

• Rate of Stem Cell Transplant

  Up to 1 year from randomization

Study Arms (2)

CPX-351 (Arm A)

EXPERIMENTAL

First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion

Drug: CPX-351

Salvage Therapy (Arm B)

ACTIVE COMPARATOR

First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice

Drug: Intensive Salvage Therapy

Interventions

CPX-351 DRUG

CPX-351 (Arm A)

Intensive Salvage Therapy DRUG

Salvage Therapy (Arm B)

Eligibility Criteria

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

You may qualify if:

• Ability to understand and voluntarily sign an informed consent form
• Age ≥18 and ≤65 years at the time of relapse
• Pathological confirmation of relapsed AML after initial CR of \>1 month duration
• Eastern Cooperative Oncology Group (ECOG) performance status 0- 2
• Able to adhere to the study visit schedule and other protocol requirements
• Laboratory values fulfilling the following:
• Serum creatinine \< 2.0 mg/dL
• Serum total bilirubin \< 2.0 mg/dL
• Serum alanine aminotransferase or aspartate aminotransferase \<3xULN Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
• Cardiac ejection fraction \> 50% by echocardiography or MUGA scan
• All men and women must agree to practice effective contraception during the study period and for 3 months afterward if not otherwise documented to be infertile.

You may not qualify if:

• Patients with active second malignancies are excluded. Patients with second malignancies in remission may be eligible if there is no clinical evidence of active disease, documented by imaging, with tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible. In all cases, the second malignancy and its non-chemotherapy treatment must not interfere with the investigators ability to assess the safety or efficacy of the study treatment
• Patients with acute promyelocytic leukemia \[t(15;17)\]
• Total lifetime anthracycline exposure exceeding the equivalent of 368 mg/m2 of daunorubicin (or equivalent) prior to start of study therapy
• Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
• Administration of any antineoplastic therapy within 4 weeks of therapy; intended to treat first relapse. In the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
• Clinical evidence of active CNS leukemia
• Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in New York Heart Association Class III or IV staging
• Active and uncontrolled infection. Patients with a bacterial infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for \>72 hrs.
• Current evidence of invasive fungal infection (blood or tissue culture); active hepatitis C infection or known HIV infection
• Hypersensitivity to cytarabine, daunorubicin or liposomal products
• History of Wilson's disease or other copper-related disorder
• Patients with a history of severe toxicity related to receiving conventional dose cytarabine in first line treatment (approximately 100mg/m2/d for \<7 days) are excluded. Patients who experienced unacceptable toxicities while receiving high dose cytarabine (approximately 3000mg/m2 for 6 doses) will not be treated again with the same regimen, but could be randomized to treatment with conventional dose cytarabine regimens where the risk of major toxicity is less.
• Woman who are pregnant or breast feeding

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (42)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

UCLA

Los Angeles, California, 90024, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UC Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Northwestern University Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center Section of Hematology/Oncology

Chicago, Illinois, 60637, United States

Location

St. Francis Cancer Center

Beech Grove, Indiana, 46107, United States

Location

University of Louisville Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Maine General Medical Center Harold Alfond Center for Cancer Care

Waterville, Maine, 04901, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

St. Louis University Medical Center

St Louis, Missouri, 63101, United States

Location

The Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

North Shore LIJ Center for Advanced Medicine Monter Cancer Center

Lake Success, New York, 11042, United States

Location

Weil Cornell Medical Center

New York, New York, 10021, United States

Location

New York Medical College

New York, New York, 10595, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Blumenthal Cancer Center/Mecklenburg Medical Group

Charlotte, North Carolina, 28204, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Jewish Hospital of Cincinatti

Cincinnati, Ohio, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Oncology and Hematology at Lehigh Valley

Bethlehem, Pennsylvania, 18105, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

UTMB Comprehensive Cancer Center

Galveston, Texas, 77555, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Joe Arrington Cancer Center

Lubbock, Texas, 79410, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79415, United States

Location

Cancer Therapy and Research Center at The University of TX Health Science Center

San Antonio, Texas, 78229, United States

Location

Intermountain LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Vancouver General Hospital/ British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 049, Canada

Location

Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez

Lille, 59037, France

Location

Service des Maladies du Sang Hopital Haut-Leveque

Pessac, 33604, France

Location

Service d'Hématologie CHU Toulouse-Hôpital Purpan

Toulouse, 31059, France

Location

Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Klinika Hematologii i Transplantologii

Gdansk, 80-952, Poland

Location

Wojewódzki Szpital Specjalistyczny im. M. Kopernika

Lodz, 93-510, Poland

Location

Oddział Hematologii

Opole, 45-372, Poland

Location

Instytut Hematologii i Transfuzjologii

Warsaw, 02-776, Poland

Location

Akademia Medyczna we Wroclawlu

Wroclaw, 50-367, Poland

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia; Recurrence; Leukemia, Myeloid

Interventions

CPX-351

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Associate Director, Clinical Trial Disclosure & Transparency
• Organization: Jazz Pharmaceuticals

(215) 832-3750

Study Officials

• Jonathan Kolitz, MD

  North Shore University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 14, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: November 24, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-10

Locations

PL (5); CA (2); FR (4); US (31)