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A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL

Primary Purpose

Acute Lymphoblastic Leukemia (ALL)

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vincristine Sulfate Liposomes Injection (VSLI)
Vincristine Sulfate Injection (VSI)
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia (ALL) focused on measuring Marqibo, HALLMARQ, leukemia, front-line, ALL, acute lymphoblastic leukemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have provided written, signed, and dated informed consent to participate in the study, in accordance with the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice (ICH GCP) Guideline E6 and all applicable local regulations. Are age >or=60 years (at the time of providing informed consent).

Have newly diagnosed, histologically proven, untreated Philadelphia chromosome-negative (Ph-) Acute lymphocytic leukemia [ALL], with >or= 5% bone marrow blasts.

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Have a life expectancy >or= 3 months.

Have renal and liver function as defined below within 14 days, inclusive, prior to study enrollment, unless the abnormality is considered attributable to leukemia:

Total bilirubin ≤ 2.0 x the upper limit of normal (ULN), unless the subject has a known diagnosis of Gilbert's disease Aspartate transaminase (AST, Serum glutamic oxaloacetic transaminase [SGOT]) or alanine transaminase (ALT, Serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x ULN Serum creatinine ≤ 1.5 x ULN. Not have had major surgery within 4 weeks before the planned start of treatment.

If female, are post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (eg, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.

If male and sexually active with a partner of child-bearing potential, agree to use an acceptable barrier method for contraception from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.

Have the ability and willingness to fully comply with study procedures and restrictions.

-

Exclusion Criteria:

Has had prior systemic chemotherapy (for ALL or other malignancy). Has had prior vincristine for any reason. Is planning to undergo stem cell transplantation (SCT) as any part of first-line therapy for ALL.

Has Burkitt's lymphoma/leukemia. Has Philadelphia chromosome-positive (Ph+) ALL and/or BCR/ABL rearrangements documented by fluorescent in-situ hybridization (FISH), cytogenetics, or polymerase chain reaction (PCR).

Has active central nervous system (CNS) disease. Has ongoing neuropathy of any etiology > Grade 1. Has a history of persistent active neurologic disorders including demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.

Prior hydroxyurea (Hydrea®) for the management of any condition other than leukocytosis or prior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea for the management of leukocytosis must be planned to be tapered off before or on Day 5 of Induction).

Has received prior steroids within 7 days before beginning protocol-specified Induction therapy for reasons other than leukocytosis (steroids for the management of leukocytosis are allowed but must be planned to be tapered off before or on Day 5 of Induction).

Has an active serious infection not controlled by oral or IV antibiotics or antifungals.

Has received any investigational therapy within 28 days before beginning any protocol-defined chemotherapeutic treatment.

-

Sites / Locations

  • UC San Diego Moores Cancer Center
  • UCLA
  • Emory University, Winship Cancer Institute
  • Northwestern University Fienberg School of Medicine
  • University of Chicago
  • Karmanos Cancer Institute
  • Washington University School of Medicine
  • Nebraska Medical Center
  • Hackensack University Medical Center
  • Roswell Park Cancer Institute
  • Cornell
  • Duke University Medical Center
  • Cleveland Clinic
  • The University of Texas, M.D. Anderson Cancer Center
  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vincristine Sulfate Injection (VSI)

Marqibo

Arm Description

VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes.

Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.

Outcomes

Primary Outcome Measures

Overall Survival
Overall survival was defined as the time from the date of study randomization until death from any cause. Observations censored at the date of the last follow-up for subjects not known to have died.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2011
Last Updated
September 6, 2021
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01439347
Brief Title
A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL
Official Title
Phase 3 Study of Study to Evaluate Marqibo® in the Combination Chemotherapy in the Treatment of Subjects >or=60 Years Old With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A phase 3 study in the treatment of subjects >or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).
Detailed Description
A phase 3, multicenter, randomized study to evaluate the substitution of Marqibo® (Vincristine Sulfate Liposomes Injection, VSLI) for standard Vincristine Sulfate Injection (VSI) in the induction, intensification, and maintenance phases of combination chemotherapy in the treatment of subjects >or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia (ALL)
Keywords
Marqibo, HALLMARQ, leukemia, front-line, ALL, acute lymphoblastic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vincristine Sulfate Injection (VSI)
Arm Type
Experimental
Arm Description
VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes.
Arm Title
Marqibo
Arm Type
Experimental
Arm Description
Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Vincristine Sulfate Liposomes Injection (VSLI)
Other Intervention Name(s)
Marqibo
Intervention Description
2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Vincristine Sulfate Injection (VSI)
Other Intervention Name(s)
Vincristine
Intervention Description
1.4 mg/m^2 with a 2 mg dose cap as an IV infusion over 10 minutes.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time from the date of study randomization until death from any cause. Observations censored at the date of the last follow-up for subjects not known to have died.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have provided written, signed, and dated informed consent to participate in the study, in accordance with the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice (ICH GCP) Guideline E6 and all applicable local regulations. Are age >or=60 years (at the time of providing informed consent). Have newly diagnosed, histologically proven, untreated Philadelphia chromosome-negative (Ph-) Acute lymphocytic leukemia [ALL], with >or= 5% bone marrow blasts. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Have a life expectancy >or= 3 months. Have renal and liver function as defined below within 14 days, inclusive, prior to study enrollment, unless the abnormality is considered attributable to leukemia: Total bilirubin ≤ 2.0 x the upper limit of normal (ULN), unless the subject has a known diagnosis of Gilbert's disease Aspartate transaminase (AST, Serum glutamic oxaloacetic transaminase [SGOT]) or alanine transaminase (ALT, Serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x ULN Serum creatinine ≤ 1.5 x ULN. Not have had major surgery within 4 weeks before the planned start of treatment. If female, are post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (eg, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents. If male and sexually active with a partner of child-bearing potential, agree to use an acceptable barrier method for contraception from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents. Have the ability and willingness to fully comply with study procedures and restrictions. - Exclusion Criteria: Has had prior systemic chemotherapy (for ALL or other malignancy). Has had prior vincristine for any reason. Is planning to undergo stem cell transplantation (SCT) as any part of first-line therapy for ALL. Has Burkitt's lymphoma/leukemia. Has Philadelphia chromosome-positive (Ph+) ALL and/or BCR/ABL rearrangements documented by fluorescent in-situ hybridization (FISH), cytogenetics, or polymerase chain reaction (PCR). Has active central nervous system (CNS) disease. Has ongoing neuropathy of any etiology > Grade 1. Has a history of persistent active neurologic disorders including demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions. Prior hydroxyurea (Hydrea®) for the management of any condition other than leukocytosis or prior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea for the management of leukocytosis must be planned to be tapered off before or on Day 5 of Induction). Has received prior steroids within 7 days before beginning protocol-specified Induction therapy for reasons other than leukocytosis (steroids for the management of leukocytosis are allowed but must be planned to be tapered off before or on Day 5 of Induction). Has an active serious infection not controlled by oral or IV antibiotics or antifungals. Has received any investigational therapy within 28 days before beginning any protocol-defined chemotherapeutic treatment. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan M O'Brien, MD
Organizational Affiliation
MD Anderson
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Emory University, Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University Fienberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The University of Texas, M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL

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