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CompletedNCT01303796SEAMLESSUpdated Jun 22, 2022Results posted

A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 3 interventional study of Sapacitabine and Decitabine in Acute Myeloid Leukemia, sponsored by Cyclacel Pharmaceuticals, Inc.. Completed at 118 sites in 12 countries. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2022-06-22.

Sponsored by Cyclacel Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
482
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study summary

This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

Read the detailed description

This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.

02

Conditions studied

  • Acute Myeloid Leukemia

Keywords

  • AML
03

In context

Leukemia

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

This study's enrollment of 482 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Cyclacel Pharmaceuticals, Inc. is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newly diagnosed AML based on WHO (World Health Organization) classification
  • Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • Adequate renal function
  • Adequate liver function
  • Able to swallow capsules
  • Agree to practice effective contraception
  • Ability to understand and willingness to sign the informed consent form

Exclusion criteria

Exclusion Criteria:

  • AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
  • Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for preceding myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD)
  • Known or suspected central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness
  • Known hypersensitivity to decitabine
  • Known to be HIV-positive
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
482 participants (actual)

Study arms

  • Experimental
    Sapacitabine-decitabine alternating

    Arm A sapacitabine administered in alternating cycles with decitabine

    Drug: Sapacitabine · Drug: Decitabine

  • Active comparator
    Decitabine

    Arm C Decitabine

    Drug: Decitabine

Interventions

  • DrugSapacitabine

    Oral sapacitabine capsules

    Also known as: CYC682

  • DrugDecitabine

    Decitabine intravenous

    Also known as: Decitabine intravenous

06

What researchers measure

Primary outcomes

  1. Overall Survival

    The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.

    Time frame: up to 43 months

Secondary outcomes

  1. Complete Remission (CR)

    Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

    Time frame: up to 43 months

  2. Complete Remission With Incomplete Platelet Count Recovery (CRp)

    Normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia. \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

    Time frame: up to 43 months

  3. Partial Remission (PR)

    Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\* \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

    Time frame: up to 43 months

  4. Hematological Improvement

    HI with duration (HI) 1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements 2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3 3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3 * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

    Time frame: up to 43 months

  5. Stable Disease (SD)

    Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks.

    Time frame: up to 43 months

  6. Blood Products Transfused

    Number of units of packed red blood cells (PRBC) and/or platelet transfusions administered per 8-week period prior to the first dose of study drug and through the date of treatment discontinuation.

    Time frame: up to 43 months

  7. Hospitalized Days

    In-patient days in hospital.

    Time frame: up to 12 months

  8. 1-year Survival

    One-year survival is the percentage of patients who are alive at 1-year measured from the date of randomization.

    Time frame: Percentage of patients alive at 1 year after randomization (participants were assessed up to 43 months for overall survival curve estimation but this measure presents the 1 year survival rate percentage).

  9. Duration of Complete Remission (dCR)

    Durations of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

    Time frame: up to 43 months

  10. Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)

    Duration of normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia. \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

    Time frame: up to 43 months

  11. Duration of Partial Remission (dPR)

    Duration of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\* \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

    Time frame: up to 43 months

  12. Duration of Hematological Improvement (dHI)

    Duration of HI 1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements 2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3 3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3 * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

    Time frame: up to 43 months

  13. Duration of Stable Disease (dSD)

    Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks.

    Time frame: up to 43 months

07

Results

Posted Jun 22, 2022
Limitations and caveats
Point to note: The Lead-in AML patients in the sapacitabine-decitabine alternate dosing arm (n=21) were not considered for efficacy assessment.

Participant flow

Lead In Phase
Participant flow — Lead In Phase
MilestoneLead In PhaseSapacitabine-decitabine AlternatingDecitabine
Started2100
Completed2100
Not completed000
Randomized Phase III
Participant flow — Randomized Phase III
MilestoneLead In PhaseSapacitabine-decitabine AlternatingDecitabine
Started0241241
Completed0241241
Not completed000

Outcome measures

PrimaryOverall Survival

The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.

Time frame:
up to 43 months
Reported as:
Median · Months
Overall Survival
MonthsSapacitabine-decitabine AlternatingDecitabine
Overall Survival5.9 (4.7 to 8.0)5.7 (4.9 to 8.2)
Statistical analysis
  • Sapacitabine-decitabine Alternating vs Decitabine · Kaplan-Meier · p = <0.0249 (one-sided) · Hazard ratio (hr): 1.013 · 95% CI 0.837 to 1.226
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 (one-sided) · Cox proportional hazard: 1.08 · 95% CI 0.86 to 1.35Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 (one-sided) · Cox proportional hazard: 1.57 · 95% CI 1.12 to 2.19Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 (one-sided) · Cox proportional hazard: 1.01 · 95% CI 0.77 to 1.32Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 · Cox proportional hazard: 1.27 · 95% CI 0.94 to 1.73Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 (one-sided) · Cox proportional hazard: 1.222Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 (one-sided) · Cox proportional hazard: 1.071Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 (one-sided) · Cox proportional hazard: 0.956Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 (one-sided)Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 (one-sided)Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.
SecondaryComplete Remission (CR)

Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame:
up to 43 months
Reported as:
Count of participants · Participants
Complete Remission (CR)
ParticipantsSapacitabine-decitabine AlternatingDecitabine
Responders4026
Non-Responders198213
Missing32
Statistical analysis
  • Sapacitabine-decitabine Alternating vs Decitabine · Fisher Exact · p = 0.1468 · Cox proportional hazard: 1.340 · 95% CI 0.645 to 2.782
SecondaryComplete Remission With Incomplete Platelet Count Recovery (CRp)

Normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia. \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame:
up to 43 months
Reported as:
Count of participants · Participants
Complete Remission With Incomplete Platelet Count Recovery (CRp)
ParticipantsSapacitabine-decitabine AlternatingDecitabine
Responders55
Non-Responders233234
Missing32
SecondaryPartial Remission (PR)

Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\* \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame:
up to 43 months
Reported as:
Count of participants · Participants
Partial Remission (PR)
ParticipantsSapacitabine-decitabine AlternatingDecitabine
Responders128
Non-Responders226231
Missing32
SecondaryHematological Improvement

HI with duration (HI) 1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements 2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3 3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3 * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame:
up to 43 months
Reported as:
Count of participants · Participants
Hematological Improvement
ParticipantsSapacitabine-decitabine AlternatingDecitabine
Responders4138
Non-Responders197201
Missing32
SecondaryStable Disease (SD)

Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks.

Time frame:
up to 43 months
Reported as:
Count of participants · Participants
Stable Disease (SD)
ParticipantsSapacitabine-decitabine AlternatingDecitabine
Responders2131
Non-Responders217208
Missing32
SecondaryBlood Products Transfused

Number of units of packed red blood cells (PRBC) and/or platelet transfusions administered per 8-week period prior to the first dose of study drug and through the date of treatment discontinuation.

Time frame:
up to 43 months
Reported as:
Median · Pint
Blood Products Transfused
PintSapacitabine-decitabine AlternatingDecitabine
Blood Products Transfused20 (0 to 337)14 (0 to 260)
Statistical analysis
  • Sapacitabine-decitabine Alternating vs Decitabine · Wilcoxon (Mann-Whitney) · p = 0.0416
SecondaryHospitalized Days

In-patient days in hospital.

Time frame:
up to 12 months
Reported as:
Median · Days
Hospitalized Days
DaysSapacitabine-decitabine AlternatingDecitabine
Hospitalized Days15 (0 to 93)14 (0 to 172)
Statistical analysis
  • Sapacitabine-decitabine Alternating vs Decitabine · Wilcoxon (Mann-Whitney) · p = 0.1568
Secondary1-year Survival

One-year survival is the percentage of patients who are alive at 1-year measured from the date of randomization.

Time frame:
Percentage of patients alive at 1 year after randomization (participants were assessed up to 43 months for overall survival curve estimation but this measure presents the 1 year survival rate percentage).
Reported as:
Count of participants · Participants
1-year Survival
ParticipantsSapacitabine-decitabine AlternatingDecitabine
1-year Survival8183
Statistical analysis
  • Sapacitabine-decitabine Alternating vs Decitabine · Log Rank · p = <0.0249 (one-sided) · Cox proportional hazard: 1.013 · 95% CI 0.837 to 1.226
SecondaryDuration of Complete Remission (dCR)

Durations of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame:
up to 43 months
Reported as:
Median · months
Duration of Complete Remission (dCR)
monthsSapacitabine-decitabine AlternatingDecitabine
Duration of Complete Remission (dCR)9.5 (6.1 to 13.6)10.4 (8.1 to 14.0)
SecondaryDuration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)

Duration of normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia. \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame:
up to 43 months
Reported as:
Median · months
Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)
monthsSapacitabine-decitabine AlternatingDecitabine
Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)9.5 (3.1 to 20.7)5.7 (3.0 to 12.5)
SecondaryDuration of Partial Remission (dPR)

Duration of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\* \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame:
up to 43 months
Reported as:
Median · months
Duration of Partial Remission (dPR)
monthsSapacitabine-decitabine AlternatingDecitabine
Duration of Partial Remission (dPR)2.2 (1.2 to 9.9)1.9 (0.5 to 9.8)
SecondaryDuration of Hematological Improvement (dHI)

Duration of HI 1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements 2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3 3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3 * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame:
up to 43 months
Reported as:
Median · months
Duration of Hematological Improvement (dHI)
monthsSapacitabine-decitabine AlternatingDecitabine
Duration of Hematological Improvement (dHI)5.8 (2.7 to 17.0)4.8 (3.4 to 7.2)
SecondaryDuration of Stable Disease (dSD)

Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks.

Time frame:
up to 43 months
Reported as:
Median · months
Duration of Stable Disease (dSD)
monthsSapacitabine-decitabine AlternatingDecitabine
Duration of Stable Disease (dSD)23.3 (9.1 to 33.2)14.8 (10.6 to NA)

Adverse events

Collected over Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lead In Phase21/21 (100%)17/21 (81%)—
Sapacitabine-decitabine Alternating221/241 (91.7%)199/236 (84.3%)236/236 (100%)
Decitabine211/241 (87.6%)188/233 (80.7%)232/233 (99.6%)
Most frequent serious events
Showing 10 of 43
Most frequent serious events
EventLead In PhaseSapacitabine-decitabine AlternatingDecitabine
FEBRILE NEUTROPENIABlood and lymphatic system disorders0/2151/23656/233
PNEUMONIAInfections and infestations4/2156/23655/233
BACTERAEMIAInfections and infestations3/212/2366/233
DISEASE PROGRESSIONGeneral disorders0/2131/23619/233
SEPSISInfections and infestations1/2124/23623/233
ANAEMIABlood and lymphatic system disorders2/2115/23614/233
CELLULITISInfections and infestations2/2110/23610/233
PNEUMONIA FUNGALInfections and infestations2/214/2368/233
MYOCARDIAL INFARCTIONCardiac disorders1/213/2366/233
GASTROINTESTINAL HAEMORRHAGEGastrointestinal disorders1/214/2365/233
Most frequent other events
Showing 10 of 79
Most frequent other events
EventLead In PhaseSapacitabine-decitabine AlternatingDecitabine
THROMBOCYTOPENIABlood and lymphatic system disorders—136/236129/233
ANAEMIABlood and lymphatic system disorders—127/236119/233
NEUTROPENIABlood and lymphatic system disorders—107/23688/233
CONSTIPATIONGastrointestinal disorders—85/236101/233
NAUSEAGastrointestinal disorders—98/23680/233
FATIGUEGeneral disorders—79/23672/233
DIARRHOEAGastrointestinal disorders—77/23659/233
OEDEMA PERIPHERALGeneral disorders—72/23665/233
PNEUMONIAInfections and infestations—70/23669/233
HYPOALBUMINAEMIAMetabolism and nutrition disorders—63/23654/233

Baseline characteristics

Elderly patients with newly diagnosed acute myeloid leukemia (AML) for whom the treatment of choice was low-intensity therapy by investigator assessment, or who had refused intensive induction therapy recommended by the investigator.

Age, Continuous
Age, Continuous(years)Sapacitabine-decitabine AlternatingDecitabineTotal
Median78 (70 to 92)77 (70 to 92)77 (70 to 92)
Sex: Female, Male
Sex: Female, Male(Participants)Sapacitabine-decitabine AlternatingDecitabineTotal
Female10295197
Male139146285
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Sapacitabine-decitabine AlternatingDecitabineTotal
Caucasian212194406
Black61723
Asian or Pacific Islander134
Hispanic639
American Indian or Alaska Native101
Other235
Unknown132134
08

Study locations

118 sites
  • University of Alabama Comprehensive Cancer Center
    Birmingham, Alabama 35294, United States
  • Scripps Cancer Center
    La Jolla, California 92037, United States
  • UCLA Ronald Reagan Medical Center
    Los Angeles, California 90095, United States
  • Norwalk Hospital
    Norwalk, Connecticut 06850, United States
  • Shands Cancer Hospital at University of Florida
    Gainesville, Florida 32608, United States
  • Cleveland Clinic Florida
    Weston, Florida 33331, United States
  • Winship Cancer Institute, Emory University
    Atlanta, Georgia 30322, United States
  • Blood and Marrow Transplant Group of Georgia
    Atlanta, Georgia 30342, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • The University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • St. Francis Medical Group Oncology and Hematology Specialists
    Indianapolis, Indiana 46237, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • University of Maryland Greenbaum Cancer Center
    Baltimore, Maryland 21201, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Saint Luke's Cancer Institute
    Kansas City, Missouri 64111, United States
  • St. Louis University Cancer Center
    Saint Louis, Missouri 63110, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Dartmouth - Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • John Theurer Cancer Center at the Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Westchester Hematology Oncology Group, PC
    Hawthorne, New York 10532, United States
  • Beth Israel Medical Center
    New York, New York 10003, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Stony Brook University Medical Center
    Stony Brook, New York 11794, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Gabrail Cancer Center Research
    Canton, Ohio 44718, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Saint Francis Hospital
    Greenville, South Carolina 29601, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Baylor University Medical Center
    Dallas, Texas 75246, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030-3387, United States
  • Joe Arrington Cancer Research and Treatment Center
    Lubbock, Texas 79410, United States
  • Huntsman Cancer Institute at the University of Utah
    Salt Lake City, Utah 84112, United States
  • The Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • Medizinische Universitaetsklinik
    Innsbruck, Austria
  • Elisabethinen Krankenhaus
    Linz, Austria
  • Krankenhaus der Barmherzigen Schwestern
    Linz, Austria
  • Univ. Klinik fur Innere Medizin III LKH
    Salzburg, Austria
  • Klinikum Wels-Grieskirchen GmbH
    Wels, Austria
  • AKH Wien
    Wien, Austria
  • Hanusch Krankenhaus
    Wien, Austria
  • Ziekenhuis Netwerk Antwerpen Stuivenberg
    Antwerpen, Belgium
  • AZ Sint-Jan Brugge-Oostende
    Brugge, Belgium
  • Universite Catholique de Louvain
    Brussels, Belgium
  • Centre Hospitalier De Jolimont-Lobbes
    La Louviere, Belgium
  • Cliniques Universitaires UCL de Mont-Godinne
    Yvoir, Belgium
  • CHU d'Amiens Hopital Sud
    Amiens, France
  • Centre Hospitalier de la Cote Basque
    Bayonne, France
  • CHU de Lyon - Hopital Edouard Herriot
    Lyon, France
  • Institut Paoli Calmettes
    Marseille, France
  • CHRU De Montpellier Hopital St. Eloi
    Montpellier, France
  • Centre Hospitalier De Mulhouse
    Mulhouse, France
  • Hopital St Louis Universite Paris 7
    Paris, France
  • Centre Hospitalier de Perigueux
    Perigueux, France
  • Centre Hospitalier d'Annecy
    Pringy, France
  • Centre Hospitalier de Saint-Brieuc Yves Ie Foll
    St Brieuc, France
  • CHU de Strasbourg - Hopital Civil
    Strasbourg, France
  • Strasbourg Oncologie Liberale
    Strasbourg, France
  • CHU de Tours Hopital Bretonneau
    Tours, France
  • Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin
    Berlin, Germany
  • Universitaetsklinikum Carl-Gustav-Carus Dresden
    Dresden, Germany
  • St. Johannes Hospital
    Duisburg, Germany
  • Klinikum Frankfurt Hoechst
    Frankfurt, Germany
  • Asklepios Klinik Altona
    Hamburg, Germany
  • Medizinische Hochschule Hannover
    Hannover, Germany
  • SLK Kliniken Heilbronn
    Heilbronn, Germany
  • Klinikum St. Georg
    Leipzig, Germany
  • Johannes Wesling Klinikum
    Minden, Germany
  • TU Muenchen
    Muenchen, Germany
  • Universitaetsklinikum Muenster
    Muenster, Germany
  • University of Debrecen
    Debrecen, Hungary
  • Petz Aladar Megyei Oktato Korhaz
    Győr, Hungary
  • Kaposi Mor Oktato Korhaz
    Kaposvár, Hungary
  • AOU Ospedali Riuniti Umberto I
    Ancona, Italy
  • AO Ospedali Riuniti di Bergamo
    Bergamo, Italy
  • Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli
    Bologna, Italy
  • AO Spedali Civili di Brescia
    Brescia, Italy
  • Universita Cattolica del Sacro Cuore
    Campobasso, Italy
  • AOU Careggi
    Firenze, Italy
  • AOU San Martino IST
    Genova, Italy
  • PO Vito Fazzi
    Lecce, Italy
  • Ospedale San Raffaele
    Milano, Italy
  • AORN Antonio Cardarelli
    Napoli, Italy
  • Uni. Napoli Ospedale Federico lI
    Napoli, Italy
  • AOU Maggiore della Carità di Novara
    Novara, Italy
  • AOOR Villa Sofia Cervello di Palermo
    Palermo, Italy
  • Policlinico San Matteo Di Pavia
    Pavia, Italy
  • AOU San Luigi Gonzaga
    Torino, Italy
  • Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku
    Gdansk, Poland
  • Wojewodzki Szpital Specjalistyczny
    Legnica, Poland
  • Wojewódzki Szpital Specjalistyczny w Legnicy
    Legnica, Poland
  • University of Lodz N. Copernicus Memorial Hospital
    Lodz, Poland
  • IHT Instytut Hematologii I Transfuzjologii w Warszawie
    Warsaw, Poland
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu
    Wroclaw, Poland
  • Hospital Universitari Germans Trias i Pujol ICO Badalona
    Badalona, Spain

Showing the first 100 of 118 sites across 12 countries.

09

References and documents

Publications

  • Kantarjian HM, Begna KH, Altman JK, Goldberg SL, Sekeres MA, Strickland SA, Arellano ML, Claxton DF, Baer MR, Gautier M, Berman E, Seiter K, Solomon SR, Schiller GJ, Luger SM, Butrym A, Gaidano G, Thomas XG, Montesinos P, Rizzieri DA, Quick DP, Venugopal P, Gaur R, Maness LJ, Kadia TM, Ravandi F, Buyse ME, Chiao JH. Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS). Cancer. 2021 Dec 1;127(23):4421-4431. doi: 10.1002/cncr.33828. Epub 2021 Aug 23. PubMed 34424530 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01303796
Lead sponsor
Cyclacel Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Feb 25, 2011
Start date
Oct 1, 2011
Primary completion
Dec 15, 2016
Completion
Jul 31, 2017
Results posted
Jun 22, 2022
Last update
Jun 22, 2022

Study contacts

Hagop M Kantarjian, M.D.
study chair · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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