A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 30
Updated:3/31/2019
Start Date:May 14, 2018
End Date:August 10, 2021
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard
chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic
leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete
response (CR) rate.

Screening for eligible participants will be performed within 21 days before administration of
the study drug. Participants with B-cell ALL/LL will receive treatment until disease
progression, unacceptable toxicity or achievement of CR followed by hematopoietic stem cell
transplant (HSCT). Participants with T cell ALL/LL will receive treatment for up to 2 cycles.
If disease progression is confirmed, then the participant will discontinue study treatment,
complete the End of Treatment Visit, and enter the Posttreatment Period. For those
participants who discontinue study drug prior to disease progression, disease evaluations
will continue to be performed every 8 weeks until subsequent anticancer therapy is initiated.

Inclusion Criteria:

- Documented acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) as
defined by the criteria below:

1. B-cell cohort: Stage 1; ALL in second or greater relapse or refractory to 2 prior
induction regimens with greater than or equal to (>=) 5 percent (%) blasts in the
bone marrow and aged 1 to less than (<) 18 years. Stage 2; ALL in second or
greater relapse or refractory to 2 prior induction regimens with (>=) 5% blasts
in the bone marrow and aged 1 to 30 years. LL in second or greater relapse or
refractory to 2 prior induction regimens and biopsy proven and with evidence of
measurable disease by radiologic criteria and aged 1 to 30 years.

2. T-cell cohort: Stage 1; ALL in first relapse or refractory to 1 prior
induction/consolidation regimen with (>=) 5% blasts in the bone marrow and aged 1
to <18 years. Stage 2; ALL in first relapse or refractory to 1 prior
induction/consolidation regimen with (>=) 5% blasts in the bone marrow and aged 1
to 30 years. LL in first relapse or refractory to 1 prior induction/consolidation
regimen biopsy proven and with evidence of measurable disease by radiologic
criteria and aged 1 to 30 years

- Performance status greater than or equal to (>=) 70 by Lansky scale (for participants
less than [<] 16 years of age) or Karnofsky scale (for participants [>=] 16 years of
age)

- Adequate hematology laboratory values at Cycle 1 Day 1 pre-dosing defined as follows:

1. Hemoglobin (>=) 7.5 gram per deciliter (g/dL) ([>=] 5 millimole per liter
[mmol/L]; prior red blood cell [RBC] transfusion is permitted)

2. Platelet count (>=) 10*10^9 per liter (L) (prior platelet transfusion is
permitted)

- Adequate renal function defined as normal serum creatinine for the participant's age
or creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) prior to enrollment

- Adequate liver function prior to enrollment defined as:

1. Alanine aminotransferase level less than or equal to (<=) 2.5* the upper limit of
normal (ULN),

2. Aspartate aminotransferase level (<=) 2.5* ULN, and

3. Total bilirubin (<=) 2* ULN or direct bilirubin level (<=) 2.0* ULN

Exclusion Criteria:

- Received an allogeneic hematopoietic transplant within 3 months of screening

- Active acute graft-versus-host disease of any grade or chronic graft-versus-host
disease of Grade 2 or higher

- Received immunosuppression post hematopoietic transplant within 1 month of study entry

- Philadelphia chromosome positive (Ph+) B-cell ALL eligible for tyrosine kinase
inhibitor therapy

- Has either of the following:

1. Evidence of dyspnea at rest or oxygen saturation (<=) 94 percent (%).

2. Known moderate or severe persistent asthma within the past 2 years, or
uncontrolled asthma of any classification

- Received an investigational drug, was vaccinated with live attenuated vaccines, or
used an invasive investigational medical device within 4 weeks before the planned
first dose of study drug, or is currently being treated in an investigational study

- Known to be seropositive for human immunodeficiency virus (HIV)

- Any one of the following:

1. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface
antigen [HBsAg]). Participants with resolved infection (ie, participants who are
HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc]
and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened
using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus
(HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be
excluded

2. Known to be seropositive for hepatitis C (except in the setting of a sustained
virologic response [SVR], defined as aviremia at least 12 weeks after completion
of antiviral therapy)
We found this trial at
28
sites
201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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1001 Johnson Ferry Road Northeast
Atlanta, Georgia 30342
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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Palo Alto, California 94304
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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San Francisco, California 94143
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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