Combination Chemotherapy With or Without Lestaurtinib in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia - Full Text View

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells or by stopping them from dividing. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with lestaurtinib may kill more cancer cells.

PURPOSE: This phase III trial is studying giving lestaurtinib together with combination chemotherapy to see how well it works compared to combination chemotherapy alone in treating infants with newly diagnosed acute lymphoblastic leukemia.

Condition	Intervention	Phase
Leukemia	Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: lestaurtinib Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: pegaspargase Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Chronic Lymphocytic Leukemia Leukemia Steroids

Drug Information available for: Dexamethasone Hydrocortisone acetate Cyclophosphamide Hydrocortisone Prednisolone Mercaptopurine Prednisolone acetate Prednisone Methylprednisolone acetate Methotrexate Methylprednisolone Prednisolone sodium phosphate Hydrocortisone sodium succinate Cytarabine Prednisolone phosphate Hydrocortisone cypionate Dexamethasone acetate Leucovorin calcium Prednisolone sodium succinate Vincristine sulfate Methylprednisolone sodium succinate Dexamethasone sodium phosphate Asparaginase Hydrocortisone butyrate Methotrexate sodium Daunorubicin Daunorubicin hydrochloride Etoposide Hydrocortisone valerate Levoleucovorin Hydrocortisone probutate Etoposide phosphate Pegaspargase Daunorubicin citrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival at 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dose of lestaurtinib [ Designated as safety issue: No ]
Pharmacokinetic and pharmacodynamic profile of lestaurtinib [ Designated as safety issue: No ]
Molecular mechanisms of resistance to lestaurtinib in leukemic blasts [ Designated as safety issue: No ]
Levels of minimal residual disease [ Designated as safety issue: No ]
Gene expression patterns [ Designated as safety issue: No ]
Outcome of infants with MLL-germline ALL treated with a modified chemotherapy backbone that includes an extended continuation phase [ Designated as safety issue: No ]

Estimated Enrollment:	315
Study Start Date:	January 2008
Estimated Primary Completion Date:	September 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Post-induction therapy A Patients receive combination chemotherapy for up to 104 weeks.	Drug: asparaginase Given IV, IM, or orally Drug: cyclophosphamide Given IV, IM, or orally Drug: cytarabine Given IT Drug: daunorubicin hydrochloride Given IV, IM, or orally Drug: dexamethasone Given IV, IM, or orally Drug: etoposide Given IV, IM, or orally Drug: leucovorin calcium Given IV, IM, or orally Drug: mercaptopurine Given IV, IM, or orally Drug: methotrexate Given IT Drug: methylprednisolone Given IV, IM, or orally Drug: pegaspargase Given IV, IM, or orally Drug: prednisone Given IV, IM, or orally Drug: therapeutic hydrocortisone Given IT Drug: vincristine sulfate Given IV, IM, or orally
Active Comparator: Post-induction therapy B Patients receive a different combination chemotherapy regimen than in post-induction therapy A for up to 104 weeks.	Drug: asparaginase Given IV, IM, or orally Drug: cyclophosphamide Given IV, IM, or orally Drug: cytarabine Given IT Drug: daunorubicin hydrochloride Given IV, IM, or orally Drug: dexamethasone Given IV, IM, or orally Drug: etoposide Given IV, IM, or orally Drug: leucovorin calcium Given IV, IM, or orally Drug: mercaptopurine Given IV, IM, or orally Drug: methotrexate Given IT Drug: methylprednisolone Given IV, IM, or orally Drug: pegaspargase Given IV, IM, or orally Drug: prednisone Given IV, IM, or orally Drug: therapeutic hydrocortisone Given IT Drug: vincristine sulfate Given IV, IM, or orally
Experimental: Post-induction therapy C Patients receive lestaurtinib and a different combination chemotherapy regimen than in either post-induction therapy A or post-induction therapy B for up to 104 weeks.	Drug: asparaginase Given IV, IM, or orally Drug: cyclophosphamide Given IV, IM, or orally Drug: cytarabine Given IT Drug: daunorubicin hydrochloride Given IV, IM, or orally Drug: dexamethasone Given IV, IM, or orally Drug: etoposide Given IV, IM, or orally Drug: lestaurtinib Given orally Drug: leucovorin calcium Given IV, IM, or orally Drug: mercaptopurine Given IV, IM, or orally Drug: methotrexate Given IT Drug: methylprednisolone Given IV, IM, or orally Drug: pegaspargase Given IV, IM, or orally Drug: prednisone Given IV, IM, or orally Drug: therapeutic hydrocortisone Given IT Drug: vincristine sulfate Given IV, IM, or orally

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 1 Year
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia
- T-cell ALL allowed
- Bilineage or biphenotypic acute leukemia allowed provided the morphology and immunophenotype are predominately lymphoid
- No mature B-cell ALL or acute myelogenous leukemia (AML)
Must be < 366 days of age at diagnosis; neonates in the first month of life must be > 36 weeks gestational age at diagnosis
Must be enrolled on protocol COG-AALL08B1 prior to enrollment on this protocol
Previously untreated except for the following:
- Any amount of steroid pretreatment allowed, provided that the patient meets all other eligibility requirements
  - Inhalation steroids are not considered as pretreatment
- Intrathecal (IT) chemotherapy (per protocol) is allowed for patient convenience at the time of the diagnostic bone marrow or venous line placement to avoid second lumbar puncture
No B-cell ALL or acute myelogenous leukemia

PATIENT CHARACTERISTICS:

No Down syndrome

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent chronic steroid treatment for another disease
No other concurrent non-protocol chemotherapy or investigational therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557193

Show 149 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Joanne M. Hilden, MD	St. Vincent Indianapolis Hospital
Investigator:	Patrick A. Brown, MD	Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Brown P, Hilden JM, Dreyer ZE, et al.: Report on excessive induction toxicity in infants with ALL enrolled on COG protocol AALL0631: A Children's Oncology Group study. [Abstract] Blood 114 (22): A-3091, 2009.

Responsible Party:	Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier:	NCT00557193 History of Changes
Other Study ID Numbers:	CDR0000573996, COG-AALL0631
Study First Received:	November 9, 2007
Last Updated:	November 20, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

untreated childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
acute undifferentiated leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Pegaspargase
Asparaginase

Daunorubicin
Dexamethasone
Etoposide
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Vincristine
BB 1101
Dexamethasone acetate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Methylprednisolone acetate
Prednisolone acetate
Hydrocortisone

ClinicalTrials.gov processed this record on May 19, 2013