Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Browse trials for

• Leukemia 5,441
• Leukemia, Myeloid 2,443
• Leukemia, Myeloid, Acute 2,971

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 44 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Study arms

• Experimental
  Arm I (guadecitabine)

  INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

  Drug: Guadecitabine

• Experimental
  Arm II (CLOSED) (guadecitabine)

  INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

  Drug: Guadecitabine

• Experimental
  Arm III (guadecitabine, idarubicin)

  INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

  Drug: Guadecitabine · Drug: Idarubicin

• Experimental
  Arm IV (CLOSED) (guadecitabine, cladribine)

  INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

  Drug: Cladribine · Drug: Guadecitabine

Interventions

• DrugCladribine

  Given IV

  Also known as: 2-CdA, 2CDA, CdA, Cladribina, Leustat, Leustatin, Leustatine, RWJ-26251

• DrugGuadecitabine

  Given SC

  Also known as: DNMT inhibitor SGI-110, S110, SGI-110

• DrugIdarubicin

  Given IV

  Also known as: 4-Demethoxydaunomycin, 4-demethoxydaunorubicin, 4-DMDR

Primary outcomes

1. Number of Participants With a Complete Response

   Complete Response = Complete Remission (CR) + Complete Remission without blood count recovery (CRi) - CR: Neutrophil count \>/= 1.0 x 10\^9/L and platelet count \>/= 100 x 10\^9/L, and normal bone marrow differential (\</+ 5% blasts). (CRi): Peripheral blood and bonemarrow results as for CR, but with platelet counts of \< 100 x 109/L or ANC \< 1.0 x 109/L

   Time frame: Up to 4 years, 3 months

2. Remission Duration

   The date of Complete Response to the date of loss of response or last follow-up.

   Time frame: Up to 4 years, 3 months

3. Leukemia-free Survival

   Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups. Time from date of treatment start until the date of first objective documentation of disease-relapse.

   Time frame: Up to 4 years, 3 months

4. Survival

   Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.

   Time frame: Up to 4 years, 3 months

5. Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event.

   The most frequently reported adverse events will be determined by the Principal Investigator. The number of participants who experienced the most frequent grade 3 or 4 adverse events will be reported.

   Time frame: Up to 4 years, 3 months

Baseline characteristics

Related links

• University of Texas MD Anderson Cancer Center Website ↗

Study documents

• Protocol and statistical analysis plan · Feb 3, 2017

Documents are hosted by the registry — open the source record to download them.