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

NCT ID: NCT00039377

Last Updated: 2014-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. Determine the activity of imatinib mesylate (Gleevec) to prolong disease-free survival (DFS) and overall survival in acute lymphoblastic leukemia (ALL) patients with t(9;22).

II. Determine the ability of imatinib mesylate (Gleevec) to produce or maintain a BCR-ABL-negative status, as judged by real-time-polymerase chain reaction (RT-PCR) following sequential chemotherapy, imatinib mesylate (Gleevec) and transplantation.

III. Determine the feasibility of collecting adequate peripheral blood stem cells for autologous transplantation following imatinib mesylate (Gleevec) therapy.

IV. Study the safety and efficacy of autologous peripheral stem cell transplantation following therapy with imatinib mesylate (Gleevec).

V. Study the safety and efficacy of allogeneic stem cell transplantation following therapy with imatinib mesylate (Gleevec).

VI. Study the safety and efficacy of imatinib mesylate (Gleevec) administered after allogeneic or autologous stem cell transplant.

OUTLINE:

COURSE I (remission induction): Patients receive 1 course of front-line induction therapy on a Cancer and Leukemia Group B (CALGB)/Southwest Oncology Group (SWOG) protocol prior to enrollment.

COURSE II (imatinib mesylate): Patients receive imatinib mesylate orally (PO) twice daily on days 1-28.

COURSE III (CNS prophylaxis): Within 7 days after completing course II, patients receive methotrexate intrathecally (IT), methotrexate intravenously (IV) over 3 hours, and vincristine sulfate IV on days 1, 8, and 15; methotrexate PO every 6 hours on days 1-2, 8-9, and 15-16; leucovorin calcium IV on days 2, 9, and 16; and leucovorin calcium PO every 6 hours on days 3, 4, 10, 11, 17, and 18.

COURSE IV (imatinib mesylate): After blood counts recover after completion of course III, patients receive imatinib mesylate as in course II.

COURSE V: Patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT), autologous PBSCT, or no PBSCT.

COURSE Va (allogeneic PBSCT for patients with human leukocyte antigen \[HLA\]-matched sibling donor): Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim subcutaneously (SC) beginning on day 4 and continuing until blood counts recover.

COURSE Vb (autologous PBSCT for patients without HLA-matched sibling donor): Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive filgrastim SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive filgrastim SC beginning on day 0 and continuing until blood counts recover.

COURSE Vc (no transplantation for patients who are not transplant candidates): Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive filgrastim SC once or twice a day beginning on day 14 and continuing until blood counts recover.

COURSE VI: Patients receive imatinib mesylate PO once or twice daily beginning on day 30 post transplantation or on day 30 if no transplantation received and continuing for at least 1 year or until patient has 2 consecutive negative reverse transcriptase-polymerase chain reaction assays at least 3 months apart or until relapse.

After completion of study treatment, patients are followed up monthly for 1 year, every 3 months for 2 years, every 6 months for 2 years, then yearly for 5 years.

Conditions

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Adult Acute Lymphoblastic Leukemia in Remission

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (imatinib mesylate, chemotherapy, PBSCT)

See Detailed Description.

Group Type EXPERIMENTAL

imatinib mesylate

Intervention Type DRUG

Given PO

methotrexate

Intervention Type DRUG

Given IT and IV

vincristine sulfate

Intervention Type DRUG

Given IV

leucovorin calcium

Intervention Type DRUG

Given IV and PO

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Undergo PBSCT

autologous hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Undergo autologous PBSCT

allogeneic hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Undergo allogeneic PBSCT

total-body irradiation

Intervention Type RADIATION

Undergo TBI

tacrolimus

Intervention Type DRUG

Given IV or PO

filgrastim

Intervention Type BIOLOGICAL

Given SC

etoposide

Intervention Type DRUG

Given IV

cyclophosphamide

Intervention Type DRUG

Given IV

cytarabine

Intervention Type DRUG

Given IV

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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imatinib mesylate

Given PO

Intervention Type DRUG

methotrexate

Given IT and IV

Intervention Type DRUG

vincristine sulfate

Given IV

Intervention Type DRUG

leucovorin calcium

Given IV and PO

Intervention Type DRUG

peripheral blood stem cell transplantation

Undergo PBSCT

Intervention Type PROCEDURE

autologous hematopoietic stem cell transplantation

Undergo autologous PBSCT

Intervention Type PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic PBSCT

Intervention Type PROCEDURE

total-body irradiation

Undergo TBI

Intervention Type RADIATION

tacrolimus

Given IV or PO

Intervention Type DRUG

filgrastim

Given SC

Intervention Type BIOLOGICAL

etoposide

Given IV

Intervention Type DRUG

cyclophosphamide

Given IV

Intervention Type DRUG

cytarabine

Given IV

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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CGP 57148 Gleevec Glivec amethopterin Folex methylaminopterin Mexate MTX leurocristine sulfate VCR Vincasar PFS CF CFR LV PBPC transplantation PBSC transplantation peripheral blood progenitor cell transplantation transplantation, peripheral blood stem cell TBI FK 506 Prograf G-CSF Neupogen EPEG VP-16 VP-16-213 CPM CTX Cytoxan Endoxan Endoxana ARA-C arabinofuranosylcytosine arabinosylcytosine Cytosar-U cytosine arabinoside

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meir Wetzler

Role: PRINCIPAL_INVESTIGATOR

Cancer and Leukemia Group B

Locations

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Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Weiss Memorial Hospital

Chicago, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare Galesburg

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Illinois Oncology Research Association CCOP

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, United States

Site Status

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Site Status

Providence Medical Center

Kansas City, Kansas, United States

Site Status

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Site Status

Radiation Oncology Center of Olathe

Olathe, Kansas, United States

Site Status

Radiation Oncology Practice Corporation Southwest

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Site Status

Salina Regional Health Center

Salina, Kansas, United States

Site Status

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Site Status

Associates In Womens Health

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Main Office

Wichita, Kansas, United States

Site Status

Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Wichita CCOP

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Beverly Hospital

Beverly, Massachusetts, United States

Site Status

Addison Gilbert Hospital

Gloucester, Massachusetts, United States

Site Status

Commonwealth Hematology Oncology PC-Worcester

Worcester, Massachusetts, United States

Site Status

Centerpoint Medical Center LLC

Independence, Missouri, United States

Site Status

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Site Status

Radiation Oncology Practice Corporation South

Kansas City, Missouri, United States

Site Status

Radiation Oncology Practice Corporation - North

Kansas City, Missouri, United States

Site Status

Liberty Hospital

Liberty, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Montana Cancer Consortium CCOP

Billings, Montana, United States

Site Status

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

Site Status

Saint Vincent Healthcare

Billings, Montana, United States

Site Status

Hematology-Oncology Centers of the Northern Rockies PC

Billings, Montana, United States

Site Status

Billings Clinic

Billings, Montana, United States

Site Status

Deaconess Medical Center

Billings, Montana, United States

Site Status

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Internal Medicine of Bozeman

Bozeman, Montana, United States

Site Status

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Site Status

Berdeaux, Donald MD (UIA Investigator)

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Glacier Oncology PLLC

Kalispell, Montana, United States

Site Status

Kalispell Medical Oncology

Kalispell, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

Montana Cancer Specialists

Missoula, Montana, United States

Site Status

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Site Status

Cheshire Medical Center-Dartmouth-Hitchcock Keene

Keene, New Hampshire, United States

Site Status

Frisbie Hospital

Rochester, New Hampshire, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

North Shore-LIJ Health System CCOP

Manhasset, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

North Shore-LIJ Health System/Center for Advanced Medicine

New Hyde Park, New York, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Oswego Hospital

Oswego, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status

Kinston Medical Specialists PA

Kinston, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Northeastern

St. Johnsbury, Vermont, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

Countries

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United States

References

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Wetzler M, Watson D, Stock W, Koval G, Mulkey FA, Hoke EE, McCarty JM, Blum WG, Powell BL, Marcucci G, Bloomfield CD, Linker CA, Larson RA. Autologous transplantation for Philadelphia chromosome-positive acute lymphoblastic leukemia achieves outcomes similar to allogeneic transplantation: results of CALGB Study 10001 (Alliance). Haematologica. 2014 Jan;99(1):111-5. doi: 10.3324/haematol.2013.085811. Epub 2013 Sep 27.

Reference Type RESULT
PMID: 24077846 (View on PubMed)

Mims AS, Kohlschmidt J, Borate U, Blachly JS, Orwick S, Eisfeld AK, Papaioannou D, Nicolet D, Mromicronzek K, Stein E, Bhatnagar B, Stone RM, Kolitz JE, Wang ES, Powell BL, Burd A, Levine RL, Druker BJ, Bloomfield CD, Byrd JC. A precision medicine classification for treatment of acute myeloid leukemia in older patients. J Hematol Oncol. 2021 Jun 23;14(1):96. doi: 10.1186/s13045-021-01110-5.

Reference Type DERIVED
PMID: 34162404 (View on PubMed)

Other Identifiers

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NCI-2009-00436

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000069378

Identifier Type: -

Identifier Source: secondary_id

CALGB 10001/SWOG C10001

Identifier Type: OTHER

Identifier Source: secondary_id

CALGB-10001

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00436

Identifier Type: -

Identifier Source: org_study_id

NCT01648426

Identifier Type: -

Identifier Source: nct_alias