CompletedNCT00492856Updated Jan 10, 2023Results posted

S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia

A Phase 3 interventional study of mercaptopurine and methotrexate in Leukemia, sponsored by SWOG Cancer Research Network. Completed at 210 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-01-10.

Sponsored by SWOG Cancer Research Network · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 105
Allocation: Non-randomized
Ages: 18 Years to 120 Years
Sex: All

Study summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Sometimes the cancer may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether combination chemotherapy is more effective than observation when given as maintenance therapy in treating acute promyelocytic leukemia.

PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and methotrexate to see how well they work when given as maintenance therapy compared with observation after combination chemotherapy in treating patients with acute promyelocytic leukemia. (Randomization and observation group closed as of 8/15/10)

Read the detailed description

OBJECTIVES:

Compare disease-free survival (DFS) among patients with previously untreated low and intermediate risk acute promyelocytic leukemia (APL) who are PCR-negative for Promyelocytic-retinoic acid receptor alpha (PML-RARα) after consolidation therapy and receive maintenance therapy versus patients who receive no maintenance therapy. (Randomization and observation arm closed as of 8/15/10)
Assess the toxicity of induction, consolidation and maintenance in these patients.
Test whether gene expression profiles assessed prior to treatment are predictive of resistance to remission induction chemotherapy and correlate with detectable minimal residual disease post-consolidation therapy. (Only one patient was not in molecular remission after receiving consolidation. Therefore, the predictive value of pre-treatment gene expression profiling could not be determined and is not reported here).
Investigate in a preliminarily manner the outcomes of patients who fail to achieve or maintain PCR-negative PML-RARα fusion gene after consolidation therapy when treated with gemtuzumab ozogamicin. (Only one patient was treated with gemtuzumab ozogamicin as part of protocol treatment. Therefore, results for this objective are not reported).

OUTLINE: This is a randomized, multicenter study.

Induction therapy: Patients receive oral tretinoin twice daily until morphologic complete remission (CR) or for a maximum of 90 days in the absence of disease progression or unacceptable toxicity. Patients also receive cytarabine IV continuously on days 3-9 and daunorubicin hydrochloride IV on days 3-6.
Consolidation therapy: Patients who achieve CR, CR with incomplete blood count recovery (CRi), or partial remission (PR) after induction therapy receive arsenic trioxide IV over 2 hours 5 days a week for 5 weeks. After a 2-week rest period, patients receive a second course of arsenic trioxide. Within 14-30 days after blood count recovery, patients receive oral tretinoin twice daily on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients receive a second course of tretinoin and daunorubicin hydrochloride after adequate blood count recovery.
Post-consolidation therapy: Patients who do not achieve molecular CR (CRm), but do achieve CR or CRi and are still PML-RARα-positive after consolidation therapy, receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment repeats every 14 days for up to 6 courses or until PML-RARα-negative by PCR. (closed as of 8/15/10)Patients are stratified according to age (18 to 60 years vs > 60 years), acute promyelocytic leukemia (APL) risk group (low vs intermediate), and if the patient received consolidation therapy courses 3 or 4 (yes vs no) regardless of their CRm response. These patients are randomized to 1 of 2 treatment arms. (Randomization and observation arm closed as of 8/15/10) All patients are non-randomly assigned to receive post-consolidation therapy.
- Arm I: Beginning 14-30 days after blood count recovery, patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year.
- Arm II: Patients receive no further chemotherapy. Patients are followed every 3 months for 1 year. (Randomization and observation arm closed as of 8/15/10) Patients undergo blood collection periodically for cytogenetic studies. Samples are analyzed for PML-RARα fusion gene via reverse transcriptase-polymerase chain reaction (RT-PCR) assay and gene expression profiling.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Conditions studied

Leukemia

Browse trials for

Keywords

adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute promyelocytic leukemia (M3)
untreated adult acute myeloid leukemia

In context

Leukemia

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

This study's enrollment of 105 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

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

Who can participate

Ages eligible: 18 Years to 120 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

DISEASE CHARACTERISTICS:

Cytologically confirmed acute promyelocytic leukemia (APL) or the variant form of APL
- Previously untreated disease
- Low- or intermediate-risk disease
  - Low-risk disease, defined as white blood cell (WBC) ≤ 10,000/mm\^3 and platelet count > 40,000/mm\^3
  - Intermediate-risk disease, defined as WBC ≤ 10,000/mm\^3 and platelet count ≤ 40,000/mm\^3
  - WBC and platelet count confirming low- or intermediate-risk disease must be obtained within 48 hours prior to study registration unless the patient received tretinoin therapy prior to study registration in which case the WBC and platelet count must be obtained within 48 hours prior to study therapy
PML-RARα fusion gene positive by reverse transcriptase-polymerase chain reaction (RT-PCR) assay
No recurrent disease
Must be registered on clinical trials SWOG-9007 and SWOG-S9910
- Specimens must be collected prior to tretinoin therapy and may be collected after tretinoin therapy

PATIENT CHARACTERISTICS:

Zubrod performance status 0-3
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception for ≥ 1 month prior to, during, and for 2 months after completion of study treatment
No unstable cardiac arrhythmia or unstable angina
No other malignancy within the past 5 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Adequately treated stage I or II cancer (except for highly aggressive malignancies with a high rate of early relapse) currently in complete remission

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
No prior systemic chemotherapy, hydroxyurea, or leukapheresis for acute leukemia
- Prior tretinoin at a dose of ≤ 45 mg/m\^2/day allowed provided it was received ≤ 5 days prior to study registration

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 105 participants (actual)

Study arms

Experimental
Post-consolidation therapy arm I
Patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year.
Drug: mercaptopurine · Drug: methotrexate · Drug: tretinoin
No intervention
Post-consolidation therapy arm II
Patients receive no further chemotherapy. Patients are followed every 3 months for 1 year. (Randomization and observation arm closed as of 8/15/10)

Interventions

Drugmercaptopurine
Given orally
Drugmethotrexate
Given orally
Drugtretinoin
Given orally

What researchers measure

Primary outcomes

3-year Disease-free Survival (DFS) Rate
DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient \> 10\^-5 based on RT-PCR performed at appropriate central lab.
Time frame: Up to 3 years

Secondary outcomes

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. Only adverse events that are possibly, probably, or definitely related to study drug are reported.
Time frame: Up to 5 years

Results

Posted Jul 18, 2014

Participant flow

Induction

Participant flow — Induction
Milestone	Low and Intermediate Risk APL Patients	Post-consolidation ATRA, 6-MP, MTX	Post-consolidation Observation	Post-consolidation Gemtuzumab Ozogamicin
Started	105	0	0	0
Completed	99	0	0	0
Not completed	6	0	0	0
Withdrew: Adverse event	2	0	0	0
Withdrew: Withdrawal by subject	1	0	0	0
Withdrew: Death	3	0	0	0

Consolidation

Participant flow — Consolidation
Milestone	Low and Intermediate Risk APL Patients	Post-consolidation ATRA, 6-MP, MTX	Post-consolidation Observation	Post-consolidation Gemtuzumab Ozogamicin
Started	92	0	0	0
Completed	83	0	0	0
Not completed	9	0	0	0
Withdrew: Adverse event	6	0	0	0
Withdrew: Not protocol specified	2	0	0	0
Withdrew: Lost to follow-up	1	0	0	0

Post-consolidation

Participant flow — Post-consolidation
Milestone	Post-consolidation ATRA, 6-MP, MTX	Post-consolidation Observation	Post-consolidation Gemtuzumab Ozogamicin
Started	41	27	1
Completed	29	0	0
Not completed	12	27	1
Withdrew: Adverse event	4	0	1
Withdrew: Withdrawal by subject	4	0	0
Withdrew: Death	1	0	0
Withdrew: Not protocol specified	1	0	0
Withdrew: Lost to follow-up	2	0	0
Withdrew: Observation arm	0	27	0

Outcome measures

SecondaryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. Only adverse events that are possibly, probably, or definitely related to study drug are reported.

Time frame:: Up to 5 years
Reported as:: Number · Participants

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Participants	ATRA + Ara-C + Daunorubicin	Consolidation	ATRA+6-MP+MTX	Gemtuzumab Ozogamicin
ALT, SGPT (serum glutamic pyruvic transaminase)	5	3	2	0
AST, SGOT	2	2	1	0
Acidosis (metabolic or respiratory)	1	0	0	0
Albumin, serum-low (hypoalbuminemia)	4	0	0	0
Alkaline phosphatase	1	0	0	0
Alkalosis (metabolic or respiratory)	2	0	0	0
Anorexia	4	1	0	0
Bilirubin (hyperbilirubinemia)	7	0	1	0
CPK (creatine phosphokinase)	2	0	0	0
Calcium, serum-low (hypocalcemia)	3	1	0	0
Cardiac Arrhythmia-Other (Specify)	1	0	0	0
Cardiac troponin T (cTnT)	2	0	0	0
Cholesterol, serum-high (hypercholesterolemia)	1	0	0	0
Coagulation-Other (Specify)	2	0	0	0
Confusion	4	0	0	0
Creatinine	2	0	0	0
DIC (disseminated intravascular coagulation)	11	0	0	0
Dehydration	0	1	0	0
Diarrhea	11	0	0	0
Distention/bloating, abdominal	2	0	0	0
Dizziness	1	0	0	0
Dry skin	1	0	0	0
Dysphagia (difficulty swallowing)	0	1	0	0
Dyspnea (shortness of breath)	11	0	0	0
Enteritis (inflammation of the small bowel)	1	0	0	0
Extremity-lower (gait/walking)	1	0	0	0
Fatigue (asthenia, lethargy, malaise)	8	5	1	0
Febrile neutropenia	58	8	0	1
Fever in absence of neutropenia, ANC lt1.0x10e9/L	1	1	0	0
Flu-like syndrome	0	1	0	0
Glucose, serum-high (hyperglycemia)	4	5	0	0
Hemoglobin	37	4	3	0
Hemorrhage, CNS	1	0	0	0
Hemorrhage, GI - Rectum	1	0	0	0
Hemorrhage, GU - Vagina	1	0	0	0
Hemorrhage, pulmonary/upper respiratory - Lung	1	0	0	0
Hemorrhage, pulmonary/upper respiratory - Nose	2	0	0	0
Hypertension	3	1	0	0
Hypotension	1	2	0	0
Hypoxia	6	0	0	0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood	10	1	0	0
Inf (clin/microbio) w/Gr 3-4 neuts - Cecum	1	0	0	0
Inf (clin/microbio) w/Gr 3-4 neuts - Colon	4	0	1	0
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth	1	0	0	0
Inf (clin/microbio) w/Gr 3-4 neuts - Lung	8	0	1	0
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	1	0	0	0
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus	0	0	1	0
Inf (clin/microbio) w/Gr 3-4 neuts - Skin	3	0	0	0
Inf (clin/microbio) w/Gr 3-4 neuts - UTI	1	0	0	0
Inf (clin/microbio) w/Gr 3-4 neuts - Up aerodigest	1	0	0	0
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	0	0	1	0
Inf w/normal ANC or Gr 1-2 neutrophils - Blood	1	5	0	0
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	0	1	0	0
Inf w/normal ANC or Gr 1-2 neutrophils - Gallbladd	1	0	0	0
Inf w/normal ANC or Gr 1-2 neutrophils - Skin	3	1	0	0
Inf w/unknown ANC - Oral cavity-gums (gingivitis)	1	0	0	0
Infection with unknown ANC - Bladder (urinary)	1	0	0	0
Infection with unknown ANC - Lung (pneumonia)	1	0	0	0
Infection with unknown ANC - Rectum	1	0	0	0
Infection with unknown ANC - Skin (cellulitis)	1	0	0	0
Infection-Other (Specify)	2	0	0	0
Left ventricular systolic dysfunction	0	3	3	0
Leukocytes (total WBC)	34	37	3	0
Lymphopenia	20	20	7	0
Metabolic/Laboratory-Other (Specify)	1	0	0	0
Mood alteration - agitation	1	0	0	0
Mood alteration - anxiety	0	1	0	0
Mood alteration - depression	1	0	0	0
Mucositis/stomatitis (clinical exam) - Oral cavity	3	0	1	0
Mucositis/stomatitis (clinical exam) - Rectum	1	0	0	0
Mucositis/stomatitis (functional/symp) - Oral cav	0	1	0	0
Muscle weakness, not d/t neuropathy - Extrem-lower	1	0	0	0
Muscle weakness, not d/t neuropathy - Extrem-upper	1	0	0	0
Muscle weakness, not d/t neuropathy - body/general	2	0	0	0
Myositis (inflammation/damage of muscle)	2	0	0	0
Nausea	6	4	1	0
Neuropathy: motor	1	0	0	0
Neuropathy: sensory	0	2	0	0
Neutrophils/granulocytes (ANC/AGC)	34	55	4	0
Opportunistic inf associated w/gt=Gr 2 lymphopenia	0	1	0	0
Pain - Abdomen NOS	3	1	0	0
Pain - Back	2	0	0	0
Pain - Chest/thorax NOS	0	2	0	0
Pain - Extremity-limb	1	1	0	0
Pain - Head/headache	10	3	6	0
Pain - Joint	0	4	0	0
Pain - Muscle	3	2	0	0
Pain - Neck	1	0	0	0
Pain - Rectum	0	1	0	0
Pain - Scrotum	1	0	0	0
Pain - Throat/pharynx/larynx	0	1	0	0
Pericardial effusion (non-malignant)	1	1	0	0
Pericarditis	0	1	0	0
Petechiae/purpura (hemorrhage into skin or mucosa)	2	0	0	0
Phosphate, serum-low (hypophosphatemia)	7	1	0	0
Photosensitivity	1	0	0	0
Platelets	42	18	2	0
Pleural effusion (non-malignant)	1	0	0	0
Pneumonitis/pulmonary infiltrates	0	1	0	0
Potassium, serum-low (hypokalemia)	4	0	0	0
Prolonged QTc interval	3	6	0	0
Pruritus/itching	0	0	1	0
Rash/desquamation	3	1	0	0
Renal failure	7	1	0	0
Renal/Genitourinary-Other (Specify)	1	0	0	0
Restrictive cardiomyopathy	0	1	0	0
Retinal detachment	1	0	0	0
Retinoic acid syndrome	13	0	0	0
Sodium, serum-low (hyponatremia)	4	0	0	0
Syncope (fainting)	3	0	0	0
Thrombosis/thrombus/embolism	1	0	0	0
Triglyceride, serum-high (hypertriglyceridemia)	5	2	3	0
Typhlitis (cecal inflammation)	3	0	0	0
Uric acid, serum-high (hyperuricemia)	0	1	0	0
Vasovagal episode	1	1	0	0
Ventricular arrhythmia - Ventricular tachycardia	1	1	0	0
Vomiting	1	1	0	0
Weight gain	1	0	0	0

Primary3-year Disease-free Survival (DFS) Rate

DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient \> 10\^-5 based on RT-PCR performed at appropriate central lab.

Time frame:: Up to 3 years
Reported as:: Number · percentage of patients

3-year Disease-free Survival (DFS) Rate
percentage of patients	Post-consolidation Therapy Arm I	Post-consolidation Therapy Arm II
3-year Disease-free Survival (DFS) Rate	96 (90 to 100)	100

Adverse events

Collected over Up to 5 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ATRA + Ara-C + Daunorubicin	—	8/105 (7.6%)	105/105 (100%)
Consolidation	—	4/90 (4.4%)	89/90 (98.9%)
ATRA+6-MP+MTX	—	1/38 (2.6%)	37/38 (97.4%)
Gemtuzumab Ozogamicin	—	0/1 (0%)	1/1 (100%)

Most frequent serious events

Showing 10 of 23

Most frequent serious events
Event	ATRA + Ara-C + Daunorubicin	Consolidation	ATRA+6-MP+MTX	Gemtuzumab Ozogamicin
SVT and nodal arrhythmia - Atrial flutterCardiac disorders	0/105	0/90	1/38	0/1
Infection-OtherInfections and infestations	0/105	0/90	1/38	0/1
ALT, SGPT (serum glutamic pyruvic transaminase)Investigations	0/105	0/90	1/38	0/1
AST, SGOTInvestigations	0/105	0/90	1/38	0/1
AmylaseInvestigations	0/105	0/90	1/38	0/1
Renal failureRenal and urinary disorders	1/105	0/90	1/38	0/1
Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders	0/105	0/90	1/38	0/1
HypotensionVascular disorders	0/105	1/90	1/38	0/1
Typhlitis (cecal inflammation)Gastrointestinal disorders	2/105	0/90	0/38	0/1
Left ventricular systolic dysfunctionCardiac disorders	0/105	1/90	0/38	0/1

Most frequent other events

Showing 10 of 116

Most frequent other events
Event	ATRA + Ara-C + Daunorubicin	Consolidation	ATRA+6-MP+MTX	Gemtuzumab Ozogamicin
Febrile neutropeniaBlood and lymphatic system disorders	62/105	8/90	0/38	1/1
Pain - Abdomen NOSGastrointestinal disorders	21/105	7/90	3/38	1/1
Edema: limbGeneral disorders	25/105	13/90	4/38	1/1
Fatigue (asthenia, lethargy, malaise)General disorders	67/105	70/90	27/38	1/1
Pain-OtherGeneral disorders	5/105	3/90	1/38	1/1
Inf w/unknown ANC - Oral cavity-gums (gingivitis)Infections and infestations	1/105	0/90	0/38	1/1
InsomniaPsychiatric disorders	18/105	17/90	6/38	1/1
Pruritus/itchingSkin and subcutaneous tissue disorders	22/105	15/90	5/38	1/1
DiarrheaGastrointestinal disorders	77/105	35/90	11/38	0/1
NauseaGastrointestinal disorders	72/105	66/90	26/38	0/1

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Low and Intermediate Risk APL Patients
Median	49 (21 to 82)

Sex: Female, Male
Sex: Female, Male(Participants)	Low and Intermediate Risk APL Patients
Female	44
Male	61

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Low and Intermediate Risk APL Patients
American Indian or Alaska Native	1
Asian	7
Native Hawaiian or Other Pacific Islander	0
Black or African American	8
White	87
More than one race	0
Unknown or Not Reported	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Low and Intermediate Risk APL Patients
Hispanic or Latino	6
Not Hispanic or Latino	87
Unknown or Not Reported	12

Study locations

210 sites

Mayo Clinic Scottsdale
Scottsdale, Arizona 85259-5499, United States
Sutter Cancer Center at Roseville Medical Center
Roseville, California 95661, United States
Sutter Cancer Center
Sacramento, California 95816, United States
Stanford Cancer Center
Stanford, California 94305-5824, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware 19713, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia 20007, United States
Hematology Oncology Associates of Illinois - Berwyn
Berwyn, Illinois 60402, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois 61701, United States
St. Joseph Medical Center
Bloomington, Illinois 61701, United States
Graham Hospital
Canton, Illinois 61520, United States
Illinois CancerCare - Canton
Canton, Illinois 61520, United States
Illinois CancerCare - Carthage
Carthage, Illinois 62321, United States
Memorial Hospital
Carthage, Illinois 62321, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois 60611-3013, United States
Hematology and Oncology Associates
Chicago, Illinois 60611, United States
University of Chicago Cancer Research Center
Chicago, Illinois 60637-1470, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois 62526, United States
Eureka Community Hospital
Eureka, Illinois 61530, United States
Illinois CancerCare - Eureka
Eureka, Illinois 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois 61401, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois 61401, United States
Illinois CancerCare - Havana
Havana, Illinois 62644, United States
Mason District Hospital
Havana, Illinois 62644, United States
Kellogg Cancer Care Center
Highland Park, Illinois 60035, United States
Midwest Center for Hematology/Oncology
Joliet, Illinois 60432, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois 61443, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois 60048, United States
Illinois CancerCare - Macomb
Macomb, Illinois 61455, United States
McDonough District Hospital
Macomb, Illinois 61455, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois 60153, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois 61462, United States
La Grange Oncology Associates - Geneva
Naperville, Illinois 60563, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois 60714, United States
BroMenn Regional Medical Center
Normal, Illinois 61761, United States
Community Cancer Center
Normal, Illinois 61761, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois 61554, United States
Illinois CancerCare - Pekin
Pekin, Illinois 61603, United States
Proctor Hospital
Peoria, Illinois 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois 61637, United States
Illinois CancerCare - Peru
Peru, Illinois 61354, United States
Illinois Valley Community Hospital
Peru, Illinois 61354, United States
Illinois CancerCare - Princeton
Princeton, Illinois 61356, United States
Perry Memorial Hospital
Princeton, Illinois 61356, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois 60076, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois 61362, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois 62781-0001, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46845, United States
McFarland Clinic, PC
Ames, Iowa 50010, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa 50325, United States
Mercy Capitol Hospital
Des Moines, Iowa 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas 67905, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas 67401, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas 67214, United States
CCOP - Wichita
Wichita, Kansas 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas 67214, United States
Wesley Medical Center
Wichita, Kansas 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas 67156, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana 71315-3198, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine 04401, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21231-2410, United States
Union Hospital Cancer Program at Union Hospital
Elkton, Maryland 21921, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109-0942, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan 48123-2500, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201-1379, United States

Showing the first 100 of 210 sites.

References and documents

Publications

Coutre SE, Othus M, Powell B, Willman CL, Stock W, Paietta E, Levitan D, Wetzler M, Attar EC, Altman JK, Gore SD, Maher T, Kopecky KJ, Tallman MS, Larson RA, Appelbaum FR. Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy. Br J Haematol. 2014 May;165(4):497-503. doi: 10.1111/bjh.12775. Epub 2014 Feb 14. PubMed 24528179 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00492856
Lead sponsor: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jun 27, 2007
Start date: Jun 1, 2007
Primary completion: Dec 1, 2013
Completion: May 4, 2016
Results posted: Jul 18, 2014
Last update: Jan 10, 2023

Study contacts

Steven E. Coutre, MD

study chair · Stanford University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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