Simplified Patient Care Strategy in Decreasing Early Death in Patients With Acute Promyelocytic Leukemia



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:August 16, 2017
End Date:August 18, 2025

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A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)

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? 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:

- Positive t(15:17) by fluorescence in situ hybridization (FISH) or conventional
karyotype

- Positive promyelocytic leukemia/retinoic acid receptor PML/RAR alpha by
polymerase chain reaction (PCR)

- Patients must accept treatment and supportive care guidelines

- Referrals must be made as early as possible but no later than 5 calendar days after
ATRA therapy is initiated; consent can be obtained up till day 7 or earlier

- Co-management can be started as soon as referral is made including weekends; the
physician at the outlying facility should make every effort to call the APL expert at
the first suspicion of APL
We found this trial at
113
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 888-203-7267
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1111 Duff Ave
Ames, Iowa 50010
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Ames, Iowa 50010
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Antioch, California 94531
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Aurora, Colorado 80012
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
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Phone: 712-252-0088
Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
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Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: James L. Wade
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Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Bonne Terre, Missouri 63628
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Boone, Iowa 50036
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
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Boulder, Colorado 80303
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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
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Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Carbondale, Illinois 62902
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Carterville, Illinois 62918
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
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Centralia, Illinois 62801
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Cheyenne, Wyoming 82001
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303 East Superior Street
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Decatur, Illinois 62526
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2300 N Edward St
Decatur, Illinois 62526
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777 Bannock St
Denver, Colorado 80204
(303) 436-6000
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4567 E 9th Ave
Denver, Colorado 80220
(303) 320-2121
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
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Denver, Colorado 80218
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Denver, Colorado 80220
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Denver, Colorado 80218
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Denver, Colorado 80206
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3773 Chry Crk North Dr # 101
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Duluth, Minnesota 55805
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Duluth, Minnesota 55805
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Effingham, Illinois 62401
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501 E. Hampden Ave.
Englewood, Colorado 80113
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101 S Major St
Eureka, Illinois 61530
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820 4th St N
Fargo, North Dakota 58102
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801 Broadway North
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39400 Paseo Padre Parkway
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Fresno, California 93720
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3315 N Seminary St
Galesburg, Illinois 61401
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Honolulu, Hawaii 96819
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4500 San Pablo Rd S
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1432 Southwest Blvd.
Jefferson City, Missouri 65109
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205 Tenney St
Kewanee, Illinois 61443
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Lone Tree, Colorado 80124
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2000 N Boise Ave
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501 E Grant
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Marshalltown, Iowa 50158
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Modesto, California 95356
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1275 York Ave
New York, New York 10021
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Oakland, California 94611
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1200 Starfire Drive
Ottawa, Illinois 61350
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603 S 13th St
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221 NE Glen Oak Ave
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8940 Wood Sage Rd
Peoria, Illinois 61615
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Peoria, Illinois 61615
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Peoria, Illinois 61637
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4391 Venture Dr.
Peru, Illinois 61354
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Peru, Illinois 61354
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Philadelphia, Pennsylvania 19104
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Philadelphia, Pennsylvania 19103
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530 Park Ave East
Princeton, Illinois 61356
815-875-3010
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Rochester, Minnesota 55905
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Rohnert Park, California 94928
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Roseville, California 95678
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Roseville, California 95678
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Sacramento, California 95823
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Sacramento, California 95823
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6600 Bruceville Road
Sacramento, California 95823
(916) 688-2000
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
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Sainte Genevieve, Missouri 63670
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San Francisco, California 94115
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San Leandro, California 94577
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700 Lawrence Expy
Santa Clara, California 95051
(408) 851-1000
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Santa Rosa, California 95403
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1305 W 18th St
Sioux Falls, South Dakota 57117
(605) 333-1000
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1309 W 17th Street
Sioux Falls, South Dakota 57104
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South San Francisco, California 94080
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South San Francisco, California 94080
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Springfield, Illinois 62703
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