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A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571) (NSC # 716051, IND #61135), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adult Acute Lymphoblastic Leukemia in Remission

Thank you

Trial Information

A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571) (NSC # 716051, IND #61135), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG


PRIMARY OBJECTIVES:

I. Determine the activity of imatinib mesylate (Gleevec) to prolong disease-free survival
(DFS) and overall survival in 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 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: This is a multicenter study.

COURSE I (remission induction): Patients receive 1 course of front-line induction therapy on
a CALGB/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 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 (G-CSF) 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
G-CSF 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 G-CSF 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
G-CSF 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 up to 10 years.


Inclusion Criteria:



- Histologically confirmed acute lymphoblastic leukemia (ALL)

- Disease in complete or partial remission after 1 course of induction chemotherapy
comprising 1 of the following: intensive 4- or 5-drug regimen on a CALGB or SWOG ALL
protocol for previously untreated ALL; any standard induction regimen without
enrollment on a cooperative group frontline protocol

- BCR-ABL positive by reverse transcriptase-polymerase chain reaction or fluorescent in
situ hybridization OR detection of t(9;22)(q34;q22) or 3-way variant by metaphase
cytogenetics

- All patients must also be enrolled on protocol CLB-9862

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- No other concurrent chemotherapy

- No concurrent steroids except for adrenal failure

- No concurrent hormonal therapy except for non-disease-related conditions (e.g.,
insulin for diabetes)

- No concurrent palliative radiotherapy except whole-brain irradiation for documented
CNS disease

- No more than 6 weeks of prior imatinib mesylate during induction therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median disease-free survival

Outcome Time Frame:

19 months

Safety Issue:

No

Principal Investigator

Meir Wetzler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00436

NCT ID:

NCT00039377

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Adult Acute Lymphoblastic Leukemia in Remission
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Washington University School of MedicineSaint Louis, Missouri  63110
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Loyola University Medical CenterMaywood, Illinois  60153
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
North Shore University HospitalManhasset, New York  11030
Eastern Maine Medical CenterBangor, Maine  04401
Via Christi Regional Medical CenterWichita, Kansas  67214
Weill Medical College of Cornell UniversityNew York, New York  10021
Great Falls ClinicGreat Falls, Montana  59405
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Welch Cancer CenterSheridan, Wyoming  82801
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Salina Regional Health CenterSalina, Kansas  67401
Oswego HospitalOswego, New York  13126
Eureka HospitalEureka, Illinois  61530
Graham Hospital AssociationCanton, Illinois  61520
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Providence Medical CenterKansas City, Kansas  66112
Independence Regional Health CenterIndependence, Missouri  64050
University of RochesterRochester, New York  14642
Blood and Marrow Transplant Group of GeorgiaAtlanta, Georgia  30342-1601
Weiss Memorial HospitalChicago,, Illinois  60640
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Addison Gilbert HospitalGloucester, Massachusetts  01930
Virginia Commonwealth UniversityRichmond, Virginia  
Montana Cancer SpecialistsMissoula, Montana  59807-7877
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Saint Margaret's HospitalSpring Valley, Illinois  61362
Fort Wayne Medical Oncology and Hematology Inc - State BoulevardFort Wayne, Indiana  46845
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Radiation Oncology Practice Corporation SouthwestOverland Park, Kansas  66210
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Beverly HospitalBeverly, Massachusetts  01915
Radiation Oncology Practice Corporation - NorthKansas City, Missouri  64154
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Radiation Oncology Practice Corporation SouthKansas City, Missouri  64114
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Deaconess Medical CenterBillings, Montana  59107
Billings ClinicBillings, Montana  59107-7000
Internal Medicine of BozemanBozeman, Montana  59715
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Cheshire Medical Center-Dartmouth-Hitchcock KeeneKeene, New Hampshire  03431
State University of New York Upstate Medical UniversitySyracuse, New York  13210
Kinston Medical Specialists PAKinston, North Carolina  28501
Commonwealth Hematology Oncology PC-WorcesterWorcester, Massachusetts  01605
Monter Cancer CenterLake Success, New York  11042
Frisbie HospitalRochester, New Hampshire  03867
Radiation Oncology Center of OlatheOlathe, Kansas  66061
Cancer and Leukemia Group BChicago, Illinois  60606
North Shore-LIJ Health System CCOPManhasset, New York  11030
NortheasternSt. Johnsbury, Vermont  05819