CLAG-GO for Patients With Persistent, Relapsed or Refractory AML

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT04050280
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia Recurrent
  • Acute Myeloid Leukemia, Adult
  • Acute Myeloid Leukemia, Relapsed, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO) — DRUG
    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.

Study Details

This study involves evaluating a combination of chemotherapy drugs known as "CLAG-GO" \[cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF) and gemtuzumab ozogamicin (GO)\] in the treatment of acute myeloid leukemia (AML) that has not responded well to standard therapy or has returned after an initial remission (relapsed). The trial will be conducted at the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC). Potential participants will go through a screening period to see if they are eligible to join the study. If eligible, participants will be hospitalized for 4-5 weeks to receive study treatment with CLAG-GO, called induction chemotherapy. If tests show that the cancer is in remission after induction chemotherapy, participants may undergo further chemotherapy (known as consolidation) or may proceed with bone marrow/stem cell transplantation. Patients who receive consolidation chemotherapy and remain in remission may have up to 8 cycles of outpatient maintenance therapy. A cycle lasts about 28 days. All participants will be monitored carefully for both side effects and to see if the study treatment is working. Lab tests and exams will be conducted throughout the entire study. In addition, special studies will be done at various time points to try to understand better how the drugs work and which patients are likely to respond best.

Key Dates

Start date
Nov 1, 2019
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CLAG-GO
    Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)

Primary Outcome Measure

Response Rate (Efficacy) [ Time Frame: Responses will be assessed following induction chemotherapy, within 14 days of documented full blood count recovery. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Greenebaumn Comprehensive Cancer CenterBaltimoreMaryland21201
Veronica Kflu
[email protected]
410-328-9416
Vu H Duong, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Maryland Greenebaumn Comprehensive Cancer Center· Baltimore, MD

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