Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/3/2019
Start Date:January 29, 2016
End Date:October 2031
Contact:Tanja A. Gruber, MD, PhD
Email:tanja.gruber@stjude.org
Phone:866-278-5833

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The purpose of this study is to test the good and bad effects of the study drugs bortezomib
and vorinostat when they are given in combination with chemotherapy commonly used to treat
acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease
the number of leukemia cells, but it could also cause additional side effects. Bortezomib and
vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other
cancers in adults, but they have not been approved for treating children with leukemia. With
this research, we plan to meet the following goals:

PRIMARY OBJECTIVE:

- Determine the tolerability of incorporating bortezomib and vorinostat into an ALL
chemotherapy backbone for newly diagnosed infants with ALL.

SECONDARY OBJECTIVES:

- Estimate the event-free survival and overall survival of infants with ALL who are
treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone.

- Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.

- Compare end of induction, end of consolidation, and end of reinduction MRD levels to
Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant
outcomes.

Treatment will consist of 4 main phases: Remission Induction, Consolidation, Reinduction, and
Maintenance. High risk patients will receive a reintensification phase prior to transplant in
first remission.

REMISSION INDUCTION: Chemotherapy will be given in an attempt to induce the participant's
leukemia into remission. Drugs given are intrathecal triple drug treatment with methotrexate,
hydrocortisone and Ara-C (ITMHA); dexamethasone; vorinostat; bortezomib; PEG-asparaginase;
mitoxantrone; cyclophosphamide; cytarabine; and 6-mercaptopurine.

CONSOLIDATION PHASE: After the participant's blood counts have recovered from Remission
Induction, he/she will move to the consolidation phase. This therapy is given to kill any
remaining leukemia cells. Drugs given are ITMHA, high-dose methotrexate, and
6-mercaptopurine.

RE-INDUCTION: This phase aims to improve the participant's overall response to therapy by
again seeking to bring his/her leukemia into remission. Drugs given are ITMHA, mitoxantrone,
peg-asparaginase, dexamethasone, bortezomib, and vorinostat.

RE-INTENSIFICATION: If the participant's maximum residual disease (MRD) is not negative after
consolidation, he/she will receive intensification therapy, then go on to stem cell
transplant (SCT) (SCT not part of this study).

MAINTENANCE PHASE: Participants with negative MRD after consolidation will skip the
re-intensification phase and proceed to receive maintenance therapy to keep the leukemia from
returning. Drugs given are ITMHA, dexamethasone, vincristine, 6-mercaptopurine and
methotrexate. Each cycle of these drugs lasts 28 days and will be repeated up to 20 times as
long as there are no serious side effects.

Inclusion Criteria:

- Patient is ≤ 365 days of age at the time of diagnosis.

- Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute
undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without
extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage
or biphenotypic acute leukemia are eligible, provided the morphology and
immunophenotype are predominantly lymphoid.

- Limited prior therapy, including systemic glucocorticoids for one week or less, one
dose of vincristine, and one dose of intrathecal chemotherapy.

- Written informed consent following Institutional Review Board, NCI, FDA, and Office
for Human Research Protections (OHRP) Guidelines.

Exclusion Criteria:

- Patients with prior therapy, other than therapy specified in the Inclusion Criteria.

- Patients with mature B-cell ALL or acute myelogenous (AML).

- Patients with Down syndrome.

- Inability or unwillingness of legal guardian/representative to give written informed
consent.
We found this trial at
12
sites
11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: John Letterio, MD
Phone: 216-844-3345
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Cleveland, OH
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Paul Gaynon, MD
Phone: 323-361-5600
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Tanja A. Gruber, MD, PhD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Ivan Kirov, MD
Phone: 714-509-4348
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Bill Chang, MD
Phone: 503-494-1543
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Calgary, Alberta
Principal Investigator: Victor A. Lewis, MD
Phone: 403-955-7272
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Calgary,
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301 Hawthorne Lane
Charlotte, North Carolina 28204
Principal Investigator: Christine Bolen, MD
Phone: 704-384-1900
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Charlotte, NC
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Cincinnati, Ohio 45229
Principal Investigator: Erin Breese, MD, PhD
Phone: 513-517-1038
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Cincinnati, OH
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Minneapolis, Minnesota 55404
Principal Investigator: Michael Richards, MD
Phone: 612-813-5940
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Minneapolis, MN
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601 Childrens Lane
Norfolk, Virginia 23507
Principal Investigator: Eric Lowe, MD
Phone: 757-668-7243
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Norfolk, VA
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725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
Principal Investigator: Norman J. Lacayo, MD
Phone: 650-725-3353
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
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Palo Alto, CA
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San Diego, California 92123
Principal Investigator: Deborah Schiff, MD
Phone: 858-966-5811
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San Diego, CA
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