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Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00039377
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : March 18, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
This phase II trial studies how well giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation works in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation may be an effective treatment for acute lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
Adult Acute Lymphoblastic Leukemia in Remission Drug: imatinib mesylate Drug: methotrexate Drug: vincristine sulfate Drug: leucovorin calcium Procedure: peripheral blood stem cell transplantation Procedure: autologous hematopoietic stem cell transplantation Procedure: allogeneic hematopoietic stem cell transplantation Radiation: total-body irradiation Drug: tacrolimus Biological: filgrastim Drug: etoposide Drug: cyclophosphamide Drug: cytarabine Other: laboratory biomarker analysis Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571) (NSC # 716051), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG
Study Start Date : April 2002
Actual Primary Completion Date : April 2012
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (imatinib mesylate, chemotherapy, PBSCT)
See Detailed Description.
 Drug: imatinib mesylate
Given PO
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec

Drug: methotrexate
Given IT and IV
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX

Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS

Drug: leucovorin calcium
Given IV and PO
Other Names:
  • CF
  • CFR
  • LV

Procedure: peripheral blood stem cell transplantation
Undergo PBSCT
Other Names:
  • PBPC transplantation
  • PBSC transplantation
  • peripheral blood progenitor cell transplantation
  • transplantation, peripheral blood stem cell

Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous PBSCT

Procedure: allogeneic hematopoietic stem cell transplantation
Undergo allogeneic PBSCT

Radiation: total-body irradiation
Undergo TBI
Other Name: TBI

Drug: tacrolimus
Given IV or PO
Other Names:
  • FK 506
  • Prograf

Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen

Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213

Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana

Drug: cytarabine
Given IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Disease Free Survival [ Time Frame: Duration of treatment (up to 10 years) ]

    Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method.

    A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils >= 1.5 x 10^9/L and platelets > 100 x 10^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month.



Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Duration of study (up to 10 years) ]
    Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.

  2. Number of Participants Who Achieved a BCR-ABL Response at 12 Months [ Time Frame: 12 months ]

    BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR).

    Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene

    MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).


  3. 5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups [ Time Frame: 5 years from CR ]
    Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.

  4. 5 Year Overall Survival for Autologous & Allogeneic Transplant Groups [ Time Frame: 5 years from registration ]
    Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 by molecular analysis (RT-PCR or fluorescence in situ hybridization [FISH})

  • Prior Therapy:

    • Complete or partial remission following one course of induction chemotherapy with an intensive 4 or 5 drug regimen (with or without imatinib mesylate) on a CALGB or SWOG ALL protocol for previously untreated ALL patients

      • Note: The double induction regimen of SWOG S0333 is considered to be one course of induction chemotherapy for the purpose of this eligibility criterion; therefore, patients from S0333 may be eligible for this study only after completing the entire double induction regimen

    • Complete or partial remission following one course of therapy on any standard induction regimen (with or without imatinib mesylate) without prior enrollment on a cooperative group frontline protocol; in these instances, documentation of Philadelphia chromosome (Ph)+ positivity may occur outside a CALGB or SWOG laboratory

      • Note: CALGB institutions must enroll patients on CALGB 9862 and submission of an initial sample for the companion trial must occur at time of enrollment on CALGB C10001; enrollment on companion studies CALGB 8461 and 9665 is not required
  • No more than six weeks of prior imatinib mesylate during induction therapy before study enrollment
  • 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 imatinib mesylate (Gleevec) to allow complete clearance of drug and its principle metabolites from the body; in women of childbearing potential, a pregnancy test will be required at study entry
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039377


Locations
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Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Meir Wetzler Cancer and Leukemia Group B
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039377    
Obsolete Identifiers: NCT01648426
Other Study ID Numbers: NCI-2009-00436
NCI-2009-00436 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000069378
CALGB 10001/SWOG C10001 ( Other Identifier: Cancer and Leukemia Group B )
CALGB-10001 ( Other Identifier: CTEP )
U10CA031946 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: March 18, 2014
Last Update Posted: November 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leucovorin
Cytarabine
Cyclophosphamide
Methotrexate
Etoposide
Vincristine
 Etoposide phosphate
Imatinib Mesylate
Tacrolimus
Levoleucovorin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents