AzTrials
AzTrials

Adult Acute Lymphoblastic Leukemia in RemissionPhase 2NCT00039377

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

A Phase 2 study testing imatinib mesylate, methotrexate and vincristine sulfate in people with Adult Acute Lymphoblastic Leukemia in Remission, run by National Cancer Institute (NCI) at 97 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 to 59 years
What is being tested?
imatinib mesylate, methotrexate and vincristine sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
97 sitesUnited States
Study dates
Apr 2002to Feb 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 59 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

97 sites in 1 country.

97 sites in 1 country

United States97 sites

  • Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgia, 30342

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies PC

    Billings, Montana, 59102

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Deaconess Medical Center

    Billings, Montana, 59107

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine of Bozeman

    Bozeman, Montana, 59715

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Chicago

    Chicago, Illinois, 60637

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

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

    Columbus, Ohio, 43210

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Mason District Hospital

    Havana, Illinois, 62644

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Radiation Oncology Practice Corporation South

    Kansas City, Missouri, 64114

  • Radiation Oncology Practice Corporation - North

    Kansas City, Missouri, 64154

  • Cheshire Medical Center-Dartmouth-Hitchcock Keene

    Keene, New Hampshire, 03431

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists PA

    Kinston, North Carolina, 28501

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore-LIJ Health System CCOP

    Manhasset, New York, 11030

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • North Shore-LIJ Health System/Center for Advanced Medicine

    New Hyde Park, New York, 11040

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Radiation Oncology Center of Olathe

    Olathe, Kansas, 66061

  • Oswego Hospital

    Oswego, New York, 13126

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Radiation Oncology Practice Corporation Southwest

    Overland Park, Kansas, 66210

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois Oncology Research Association CCOP

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Frisbie Hospital

    Rochester, New Hampshire, 03867

  • University of Rochester

    Rochester, New York, 14642

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Northeastern

    St. Johnsbury, Vermont, 05819

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita CCOP

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Commonwealth Hematology Oncology PC-Worcester

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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).

  1. 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

    Also called CGP 57148, Gleevec, Glivec

    Given PO

  • methotrexateDrug

    Also called amethopterin, Folex, methylaminopterin, Mexate

    Given IT and IV

  • vincristine sulfateDrug

    Also called leurocristine sulfate, VCR, Vincasar PFS

    Given IV

  • leucovorin calciumDrug

    Also called CF, CFR, LV

    Given IV and PO

  • peripheral blood stem cell transplantationProcedure or surgery

    Also called PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell

    Undergo PBSCT

  • autologous hematopoietic stem cell transplantationProcedure or surgery

    Undergo autologous PBSCT

  • allogeneic hematopoietic stem cell transplantationProcedure or surgery

    Undergo allogeneic PBSCT

  • total-body irradiationRadiation

    Also called TBI

    Undergo TBI

  • tacrolimusDrug

    Also called FK 506, Prograf

    Given IV or PO

  • filgrastimBiological

    Also called G-CSF, Neupogen

    Given SC

  • etoposideDrug

    Also called EPEG, VP-16, VP-16-213

    Given IV

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • cytarabineDrug

    Also called ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00039377
Study groupRoleWhat they receive
Treatment (imatinib mesylate, chemotherapy, PBSCT)ExperimentalSee Detailed Description.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival

    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.

    Measured: Duration of treatment (up to 10 years)

Secondary outcomes (4)

  1. Overall Survival

    Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.

    Measured: Duration of study (up to 10 years)

  2. Number of Participants Who Achieved a BCR-ABL Response at 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).

    Measured: 12 months

  3. 5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups

    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.

    Measured: 5 years from CR

  4. 5 Year Overall Survival for Autologous & Allogeneic Transplant Groups

    Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.

    Measured: 5 years from registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2002
  3. Primary completionApr 2012
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00039377
Sponsor's protocol ID
NCI-2009-00436
Other IDs
NCI-2009-00436, CDR0000069378, CALGB 10001/SWOG C10001, CALGB-10001, U10CA031946
Status last verified
Jun 2014
First submitted
6 Jun 2002
Last updated
24 Nov 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 24077846

  • 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.

    PubMed 34162404

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate, methotrexate and vincristine sulfate in people with Adult Acute Lymphoblastic Leukemia in Remission, run by National Cancer Institute (NCI) at 97 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (time frame: Duration of treatment (up to 10 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00039377, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in