Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01409161
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Promyelocytic Leukemia With PML-RARA

Eligibility Criteria

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

Interventions

  • Arsenic Trioxide — DRUG
    Given IV
  • Gemtuzumab Ozogamicin — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Tretinoin — DRUG
    Given PO

Study Details

This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotoxins, such as gemtuzumab ozogamicin, may find certain cancer cells and kill them without harming normal cells. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.

Key Dates

Start date
Oct 5, 2011
Status verified
May 2026
Primary completion
Dec 18, 2027
Completion
Dec 18, 2027

Study Design

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

Arms

  • Experimental: Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)
    INDUCTION: Patients receive tretinoin PO BID, arsenic trioxide IV over 1-2 hours daily, and gemtuzumab ozogamicin IV over 2 hours once at weeks 1-4. CONSOLIDATION: Patients achieving CR receive arsenic trioxide IV 5 days per week during weeks 1-4, 9-12, 17-20, and 25-28 and tretinoin PO BID for 2 weeks on and 2 weeks off. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Event free survival [ Time Frame: The time from the start of treatment to first documentation of disease relapse or death, assessed up to 2 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Farhad Ravandi-Kashani
713-745-0394
Farhad Ravandi-Kashani (PRINCIPAL_INVESTIGATOR)
MD Anderson Regional Care Center-KatyHoustonTexas77094
Farhad Ravandi-Kashani
713-745-0394
Farhad Ravandi-Kashani (PRINCIPAL_INVESTIGATOR)
MD Anderson Regional Care Center-Bay AreaNassau BayTexas77058
Farhad Ravandi-Kashani
713-745-0394
Farhad Ravandi-Kashani (PRINCIPAL_INVESTIGATOR)
MD Anderson Regional Care Center-Sugar LandSugar LandTexas77478
Farhad Ravandi-Kashani
713-745-0394
Farhad Ravandi-Kashani (PRINCIPAL_INVESTIGATOR)
MD Anderson Regional Care Center-The WoodlandsThe WoodlandsTexas77384
Farhad Ravandi-Kashani
713-745-0394
Farhad Ravandi-Kashani (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TXMD Anderson Regional Care Center-Katy· Houston, TXMD Anderson Regional Care Center-Bay Area· Nassau Bay, TXMD Anderson Regional Care Center-Sugar Land· Sugar Land, TXMD Anderson Regional Care Center-The Woodlands· The Woodlands, TX

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