An interventional study of Simplified Patient Care Strategy and Laboratory Biomarker Analysis in Acute Promyelocytic Leukemia With PML-RARA and t(15;17), sponsored by ECOG-ACRIN Cancer Research Group. Active, not recruiting at 294 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by ECOG-ACRIN Cancer Research Group · Not applicable, Interventional, and Other
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Among 86 studies in Leukemia, Promyelocytic, Acute with a site in United States — 4 open to participants now, 7 under way, 2 of them phase 3. Leukemia, Promyelocytic, Acute · United States.
Among the 86 studies in Leukemia, Promyelocytic, Acute with a site in United States, this one is the 5th largest by enrollment of the 68 interventional ones that give a count, is the only one that started in 2017, is one of 2 with no phase, and was the 83rd registered.
134 studies on the registry are indexed under Leukemia, Promyelocytic, Acute; 16 are open to participants now.
Browse Leukemia, Promyelocytic, Acute studies →4 of the 86 studies in Leukemia, Promyelocytic, Acute with a site in United States are open now. Recruiting first, the newest first:
Quetzal Therapeutics · Sites in United States, France, Italy and 2 more countries
Ages 18–71
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 3–35
M.D. Anderson Cancer Center · Sites in United States
Ages 10+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 12 Leukemia, Promyelocytic, Acute studies recruiting now, 7 (58%) set no upper age limit and 5 (42%) stop at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
86 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 36 · Phase 2 36 · Phase 3 7 · Phase 4 1
First in 1987; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 202 is above the median of 51 across 100 interventional studies indexed under Leukemia, Promyelocytic, Acute.
Median enrollment 40 across the 68 interventional studies, 191 across the 6 observational. Of the 72 that completed or were terminated, 17 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 86 have an industry lead sponsor. The 10 most frequent:
ECOG-ACRIN Cancer Research Group is the lead sponsor of 122 studies on the registry; 16 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.
ECOG-ACRIN Cancer Research Group has 1 study filed under Leukemia, Promyelocytic, Acute — fewer than ten, so there is no comparison to draw.
3 of the studies in Leukemia, Promyelocytic, Acute with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07504458Phase 3Quetzal TherapeuticsPivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia | 2027-03 |
| NCT02390752National Cancer Institute (NCI)Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ... | 2026-12-31 |
| NCT02390635M.D. Anderson Cancer CenterPET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia | 2027-09-15 |
Add all 3 to your calendar (.ics) → With an account.
Among the 86 studies in Leukemia, Promyelocytic, Acute with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This clinical trial studies how well simplified patient care strategy works in decreasing early death in patients with acute promyelocytic leukemia. Implementing simplified acute promyelocytic leukemia guidelines along with support from acute promyelocytic leukemia experts may decrease deaths and improve survival.
PRIMARY OBJECTIVES:
I. To evaluate if the proposed patient care strategy, that includes use of simplified guidelines along with acute promyelocytic leukemia (APL) expert support, decreases the one-month induction mortality rate from 30% to under 15%.
SECONDARY OBJECTIVES:
I. To assess the overall survival 1 year after accrual is completed. II. To assess incidence and severity of differentiation syndrome. III. To correlate outcomes with time to initiation of all-trans retinoic acid (ATRA) from diagnosis or suspicion of diagnosis.
IV. To compare outcomes between academic and community centers separately. V. To evaluate factors associated with outcome.
OUTLINE:
Patients receive standard of care treatment for APL. Patients and doctors regularly discuss with an APL expert to identify and mange treatment.
After diagnosis, patients are followed up for 1 year.
Inclusion Criteria:
Confirmed to have a diagnosis of APL, which is defined as:
Patients receive standard of care treatment for APL. Treating physicians regularly discuss with an APL expert to identify and mange treatment.
Other: Simplified Patient Care Strategy · Other: Laboratory Biomarker Analysis
Treatment per Acute Promyelocytic Leukemia (APL) Treatment Guidelines plus discussion between doctors and APL expert
Correlative studies
One-month Mortality Rate
Proportion of patients died within one month from the first date of induction therapy.
Time frame: Assessed at one month
Survival Rate at One Year
Overall survival is defined as the time from the first date of induction therapy to death or date last known alive. Proportion of patients alive at one year was estimated using the method of Kaplan and Meier.
Time frame: Assessed at one year
One-month Survival Rate by Lead Academic Sites and Community Sites
Proportion of patients who are alive at one month since the first date of induction therapy by lead academic sites and community sites
Time frame: Assessed at one month
Differentiation Syndrome Rate
The proportion of patients with differentiation syndrome (measured based on the CTC version 4.0) will be evaluated.
Time frame: Assessed up to 1 year
Association Between One-month Mortality Rate and Time From Diagnosis to Initiation of All-trans Retinoic Acid (ATRA)
The time from diagnosis and initiation of ATRA will be assessed and dichotomized as "short' vs. "long" using the median value. One-month mortality rate will be compared in these two groups (short vs. long) using the Fisher's exact test.
Time frame: Assessed at one month
Association Between One-month Survival and Baseline Factors
The associations between one-month survival and baseline factors will be evaluated.
Time frame: Assessed at baseline and one month
This study was activated on August 16, 2017, and closed to accrual on July 2, 2021. A total of 202 patients were enrolled.
| Milestone | Simplified Patient Care Strategy Plus APL Expert Support |
|---|---|
| Started | 202 |
| Evaluable patients | 201 |
| Evaluable patients with toxicity data | 199 |
| Completed | 184 |
| Not completed | 18 |
| Withdrew: Adverse event | 7 |
| Withdrew: Death | 5 |
| Withdrew: Initiation of other treatments | 3 |
| Withdrew: Other complicating disease | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Declining health | 1 |
Proportion of patients died within one month from the first date of induction therapy.
| Proportion of participants | Simplified Patient Care Strategy Plus APL Expert Support |
|---|---|
| One-month Mortality Rate | 0.03 (0.01 to 0.06) |
Overall survival is defined as the time from the first date of induction therapy to death or date last known alive. Proportion of patients alive at one year was estimated using the method of Kaplan and Meier.
| Proportion of participants | Simplified Patient Care Strategy Plus APL Expert Support |
|---|---|
| Survival Rate at One Year | 0.945 (0.903 to 0.969) |
Proportion of patients who are alive at one month since the first date of induction therapy by lead academic sites and community sites
| Proportion of participants | Patients Accrued by Lead Academic Sites | Patients Accrued by Community Sites |
|---|---|---|
| One-month Survival Rate by Lead Academic Sites and Community Sites | 0.952 (0.857 to 0.984) | 0.978 (0.935 to 0.993) |
The proportion of patients with differentiation syndrome (measured based on the CTC version 4.0) will be evaluated.
Results for this outcome have not been posted.
The time from diagnosis and initiation of ATRA will be assessed and dichotomized as "short' vs. "long" using the median value. One-month mortality rate will be compared in these two groups (short vs. long) using the Fisher's exact test.
Results for this outcome have not been posted.
The associations between one-month survival and baseline factors will be evaluated.
Results for this outcome have not been posted.
Collected over Assessed while on treatment and for 30 days after the end of treatment, up to 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Simplified Patient Care Strategy Plus APL Expert Support | 22/201 (10.9%) | 115/199 (57.8%) | 152/199 (76.4%) |
| Event | Simplified Patient Care Strategy Plus APL Expert Support |
|---|---|
| AnemiaBlood and lymphatic system disorders | 44/199 |
| White blood cell decreasedInvestigations | 40/199 |
| Neutrophil count decreasedInvestigations | 39/199 |
| Platelet count decreasedInvestigations | 31/199 |
| Alanine aminotransferase increasedInvestigations | 19/199 |
| Lymphocyte count decreasedInvestigations | 15/199 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 14/199 |
| Febrile neutropeniaBlood and lymphatic system disorders | 13/199 |
| Aspartate aminotransferase increasedInvestigations | 13/199 |
| LeukocytosisBlood and lymphatic system disorders | 7/199 |
| Event | Simplified Patient Care Strategy Plus APL Expert Support |
|---|---|
| Aspartate aminotransferase increasedInvestigations | 91/199 |
| Alanine aminotransferase increasedInvestigations | 89/199 |
| Electrocardiogram QT corrected interval prolongedInvestigations | 59/199 |
| Retinoic acid syndromeRespiratory, thoracic and mediastinal disorders | 42/199 |
| Non-cardiac chest painGeneral disorders and administration site conditions | 13/199 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 12/199 |
| HypocalcemiaMetabolism and nutrition disorders | 11/199 |
| HypertensionVascular disorders | 11/199 |
| FatigueGeneral disorders and administration site conditions | 10/199 |
| Bone painMusculoskeletal and connective tissue disorders | 10/199 |
All evaluable patients are included...
| Age, Continuous(years) | Simplified Patient Care Strategy Plus APL Expert Support |
|---|---|
| Median | 53 (18 to 91) |
| Sex: Female, Male(Participants) | Simplified Patient Care Strategy Plus APL Expert Support |
|---|---|
| Female | 96 |
| Male | 105 |
| Ethnicity (NIH/OMB)(Participants) | Simplified Patient Care Strategy Plus APL Expert Support |
|---|---|
| Hispanic or Latino | 36 |
| Not Hispanic or Latino | 161 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | Simplified Patient Care Strategy Plus APL Expert Support |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 11 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 23 |
| White | 158 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
Showing the first 100 of 294 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Ran from Sep 2017 to primary completion in Apr 2023, 67 months.
Results were first posted in Apr 2025, 1 year 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Leukemia, Promyelocytic, Acute →
ECOG-ACRIN Cancer Research Group →