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Trial record 1 of 1 for:    NCT01256398
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Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified May 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01256398
First received: December 7, 2010
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

This phase II clinical trial is studying how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, 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. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.


Condition Intervention Phase
Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
 Biological: alemtuzumab
Drug: dasatinib
Drug: daunorubicin hydrochloride
Drug: fludarabine phosphate
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: autologous hematopoietic stem cell transplantation
Procedure: in vitro-treated peripheral blood stem cell transplantation
Drug: dexamethasone
Drug: cyclophosphamide
Biological: filgrastim
Biological: pegfilgrastim
Drug: methotrexate
Drug: leucovorin calcium
Drug: melphalan
Drug: tacrolimus
Drug: etoposide phosphate
Drug: cytarabine
Drug: mercaptopurine
Drug: vincristine sulfate
Other: pharmacological study
Other: laboratory biomarker analysis
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Dasatinib (Sprycel®) (IND #73969, NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.


Secondary Outcome Measures:
  • Probability of being BCR-ABL negative in the bone marrow and peripheral blood at the completion of the CNS prophylaxis course (restricted to those patients achieving a complete response [CR]) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Proportions will be estimated based on the combined and individual cohorts.

  • Feasibility of maintenance therapy in this patient population (restricted to those patients achieving a CR) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Proportions will be estimated based on the combined and individual cohorts.

  • Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.

  • DFS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.

  • Response [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: December 2010
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy, transplant)
See Detailed Description
 Biological: alemtuzumab
Given IV
Other Names:
  • anti-CD52 monoclonal antibody
  • Campath-1H
  • MoAb CD52
  • Monoclonal Antibody Campath-1H
  • Monoclonal Antibody CD52
Drug: dasatinib
Given PO
Other Names:
  • BMS-354825
  • Sprycel
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: fludarabine phosphate
Given IV
Other Names:
  • 2-F-ara-AMP
  • Beneflur
  • Fludara
Procedure: allogeneic hematopoietic stem cell transplantation
Undergo peripheral blood allogeneic HCT
Procedure: autologous hematopoietic stem cell transplantation
Undergo peripheral blood autologous HCT
Procedure: in vitro-treated peripheral blood stem cell transplantation
Undergo peripheral blood autologous or allogeneic HCT
Other Names:
  • in vitro-treated PBPC transplantation
  • in vitro-treated PBSC
  • in vitro-treated peripheral blood progenitor cell transplantation
  • PBPC transplantation, in vitro-treated
  • peripheral blood progenitor cell transplantation, in vitro-treated
Drug: dexamethasone
Given PO or IV
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Biological: pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • GCSF-SD01
  • Neulasta
  • SD-01 sustained duration G-CSF
Drug: methotrexate
Given IT, IV, or PO
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: leucovorin calcium
Given IV or PO
Other Names:
  • CF
  • CFR
  • LV
Drug: melphalan
Given IV
Other Names:
  • Alkeran
  • CB-3025
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin
Drug: tacrolimus
Given IV or PO
Other Names:
  • FK 506
  • Prograf
Drug: etoposide phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Drug: cytarabine
Given IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: mercaptopurine
Given PO
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unequivocal histologic diagnosis of ALL
  • Detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or BCR-ABL positive status by molecular analysis (Q-PCR or FISH) in a CLIA-approved laboratory
  • No prior therapy except up to one week of corticosteroids and/or hydroxyurea to enable time for the detection of t(9;22)(q34;q11) or BCR/ABL
  • Enrolled on required companion study CALGB-8461 (Cytogenetic Studies in Acute Leukemia)
  • Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control and contraception should continue for three months after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body; in women of childbearing potential, a pregnancy test will be required at study entry
  • Left ventricular ejection fraction >= lower limit of institutional normal
  • No myocardial infarction within 6 months
  • No ventricular tachyarrhythmia within 6 months
  • No major conduction abnormality (unless a cardiac pacemaker is present)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256398

  Show 55 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Meir Wetzler Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01256398     History of Changes
Other Study ID Numbers: NCI-2011-02621, CALGB 10701, CDR0000690286, CALGB-10701, CALGB 10701/CTSU C10701, U10CA031946
Study First Received: December 7, 2010
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
6-Mercaptopurine
Cytarabine
 Methotrexate
Fludarabine monophosphate
Vidarabine
Cyclophosphamide
Melphalan
Tacrolimus
Campath 1G
Etoposide phosphate
Fludarabine
Alemtuzumab
Daunorubicin
Dexamethasone
Etoposide
Vincristine
BB 1101

ClinicalTrials.gov processed this record on May 23, 2013