NCT00039377|CompletedPhase 2Results

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

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

National Cancer Institute (NCI)ClinicalTrials.gov

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5 other identifiers

NCI-2009-00436CDR0000069378CALGB 10001/SWOG C10001CALGB-10001U10CA031946

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedApr 2002

CompletionFeb 2014

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Apr 2002

Longer than P75 for phase_2

Geographic Reach

1 country

97 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11.8 years study duration

Study Start

First participant enrolled

April 1, 2002

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2002

Completed

8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed

2 months until next milestone

Results Posted

Study results publicly available

March 18, 2014

Completed

Last Updated

November 24, 2014

Status Verified

June 1, 2014

Enrollment Period

10 years

First QC Date

June 6, 2002

Results QC Date

November 27, 2013

Last Update Submit

November 13, 2014

Conditions

Adult Acute Lymphoblastic Leukemia in Remission

Outcome Measures

Primary Outcomes (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.
Duration of treatment (up to 10 years)

Secondary Outcomes (4)

Overall Survival
Duration of study (up to 10 years)
Number of Participants Who Achieved a BCR-ABL Response at 12 Months
12 months
5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups
5 years from CR
5 Year Overall Survival for Autologous & Allogeneic Transplant Groups
5 years from registration

Study Arms (1)

Treatment (imatinib mesylate, chemotherapy, PBSCT)

EXPERIMENTAL

See Detailed Description.

Drug: imatinib mesylateDrug: methotrexateDrug: vincristine sulfateDrug: leucovorin calciumProcedure: peripheral blood stem cell transplantationProcedure: autologous hematopoietic stem cell transplantationProcedure: allogeneic hematopoietic stem cell transplantationRadiation: total-body irradiationDrug: tacrolimusBiological: filgrastimDrug: etoposideDrug: cyclophosphamideDrug: cytarabineOther: laboratory biomarker analysis