- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04050280
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
A Phase II Study of Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor With Fractionated Gemtuzumab Ozogamicin (CLAG-GO) for the Treatment of Patients With Persistent, Relapsed or Refractory Acute Myeloid Leukemia
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Larissa Sanglard
- Phone Number: 410-328-8370
- Email: Larissa.Sanglard@umm.edu
Study Contact Backup
- Name: Veronica Kflu
- Phone Number: 410-328-9416
- Email: veronica.kflu@umm.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- Larissa Sanglard
-
Contact:
- Larissa Sanglard
- Phone Number: 410-328-8370
- Email: Larissa.Sanglard@umm.edu
-
Principal Investigator:
- Vu H Duong, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients age 18 years or older, with a pathologically confirmed diagnosis of AML [excluding acute promyelocytic leukemia (APL)] according to WHO criteria. AML may be de novo, or following a prior hematologic disease and/or therapy-related.
- Patients must have relapsed after or be refractory to at least one course of an intensive chemotherapy regimen, for example anthracycline/cytarabine ("7+3" or daunorubicin and cytarabine liposome). Patients with residual disease on day 13-22 of initial induction chemotherapy are eligible, provided the bone marrow cellularity is ≥ 30% AND bone marrow blasts are ≥ 20%. Hypomethylating agents such as azacitidine or decitabine are allowed as a prior therapy, but are not considered an intensive chemotherapy regimen.
- Eastern Cooperative Oncology Group performance status of 0-2.
- Any systemic chemotherapy and any radiotherapy must be completed at least 7 days prior to initiation of protocol therapy, with the exception of hydroxyurea or 6-mercaptopurine for cytoreduction.
- At least 20% expression of CD33 as determined by flow cytometry or immunohistochemical staining.
- Adequate renal function, defined as a serum creatinine less than 1.8 mg/dL.
- Adequate hepatic function, defined as a direct bilirubin less than 2 times the institutional upper limit of normal (ULN) and AST, ALT and Alkaline Phosphatase less than 3 times the ULN.
- Patients who relapse after allogeneic hematopoietic stem cell transplantation are eligible, provided they are at least 60 days from stem cell infusion, do not have > grade 1 graft versus host disease, and have been off all immunosuppressive therapy for at least 2 weeks.
- Female patients of childbearing potential must have a negative pregnancy test and agree to use an adequate method of contraception as defined by the protocol. This must persist through the treatment period until at least 6 months after the last dose of chemotherapy or GO.
- Male subjects who are able to father children and are having intercourse with females of childbearing potential must also agree to an acceptable method of contraception through the treatment period until at least 3 months after the last dose of chemotherapy or GO, and must refrain from sperm donation during this period.
- Ability to give written informed consent.
Exclusion Criteria:
- Patients with acute promyelocytic leukemia (FAB-M3) or chronic myelogenous leukemia in blast phase.
- Isolated myeloid sarcoma. Patients must have marrow involvement with AML to enter the study.
- Patients with known active AML involvement of the central nervous system.
- Prior treatment with gemtuzumab ozogamicin or cladribine for AML. Prior treatment with cytarabine is permitted.
- As patients will be receiving G-CSF prior to chemotherapy, patients presenting with symptomatic leukostasis (as judged by the investigator) are excluded. Hydroxyurea, 6-mercaptopurine and/or leukapheresis for blast count control (see inclusion criterion #4) for patients with asymptomatic hyperleukocytosis is permitted before starting treatment, but must be stopped for at least 24 hours prior to starting protocol treatment.
- Active uncontrolled infection. Patients on prophylactic antibacterial, antifungal, and/or antiviral agents and patients whose infections are controlled with these agents are eligible.
- Known active hepatitis B or C or other known active hepatic disorder.
- Any history of veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS).
- Active concurrent malignancy, unless disease-free for at least 3 years. Subjects with treated non-melanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been treated surgically or with definitive radiotherapy.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that per investigator's judgment would limit compliance with study requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CLAG-GO
Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)
|
Induction: G-CSF 300 mcg subcutaneously daily on days 0-5. Cladribine 5 mg/m2 in normal saline given intravenously over 2 hours daily on days 1-5. Cytarabine 2000 mg/m2 in normal saline given intravenously over 4 hours daily on days 1-5. Gemtuzumab ozogamicin 3 mg/m2 intravenously over 2 hours on days 1 and 4, prior to cladribine and cytarabine. Consolidation: If CRMRD-, CR or CRi is confirmed by bone marrow biopsy and aspirate after induction chemotherapy, patients may receive one cycle of consolidation chemotherapy (at the discretion of the investigator) with the same CLAG-GO regimen at the same doses given for induction. In addition, the investigator has the option of giving CLAG alone without GO if there is concern for increased risk of sinusoidal obstruction syndrome. Patients who remain in CRMRD-, CR or CRi after consolidation chemotherapy may receive up to eight infusions of GO 2 mg/m2 approximately every 28 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate (Efficacy)
Time Frame: Responses will be assessed following induction chemotherapy, within 14 days of documented full blood count recovery.
|
Responses will be judged according to modified European LeukemiaNet recommendations published in 2017.
Patients who achieve either 1) complete remission without minimal residual disease, 2) complete remission, or 3) complete remission with incomplete hematologic recovery will be considered responders
|
Responses will be assessed following induction chemotherapy, within 14 days of documented full blood count recovery.
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: From date of enrollment until death from any cause, whichever comes first, assessed up to 1 year.
|
All adverse events will be graded according to CTCAE version 5.
|
From date of enrollment until death from any cause, whichever comes first, assessed up to 1 year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of minimal residual disease
Time Frame: Assessed at the end of induction, consolidation and maintenance therapy, up to 1 year
|
This is determined by flow cytometry completed through Hematologics, Inc.
|
Assessed at the end of induction, consolidation and maintenance therapy, up to 1 year
|
Time to relapse or death
Time Frame: measured from the date of confirmed remission until the date of confirmed relapse, assessed up to 2 years. Time to death (survival) is measured from the date of enrollment until the date of death, assessed up to 2 years.
|
Time to relapse is measured from the date of confirmed remission until the date of confirmed relapse.
Time to death (survival) is measured from the date of enrollment until the date of death, assessed up to 2 years.
|
measured from the date of confirmed remission until the date of confirmed relapse, assessed up to 2 years. Time to death (survival) is measured from the date of enrollment until the date of death, assessed up to 2 years.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vu H. Duong, MD, MS, University of Maryland Greenebaumn Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Hematologic Diseases
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Adjuvants, Immunologic
- Immunoconjugates
- Immunotoxins
- Lenograstim
- Cytarabine
- Cladribine
- Gemtuzumab
Other Study ID Numbers
- 1946GCCC ; HP-00085334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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