CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
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|ClinicalTrials.gov Identifier: NCT04050280|
Recruitment Status : Not yet recruiting
First Posted : August 8, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia, Relapsed, Adult||Drug: Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||February 2023|
Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)
Drug: Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)
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.
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 Name: Mylotarg
- 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
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050280
|Contact: Hongxia Liemail@example.com|
|Contact: Veronica Kflufirstname.lastname@example.org|
|Principal Investigator:||Vu H. Duong, MD, MS||University of Maryland Greenebaumn Comprehensive Cancer Center|