Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049569
First received: November 12, 2002
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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. Combining more than one chemotherapy drug with imatinib mesylate may kill more cancer cells. Randomized phase II trial to study the effectiveness of combination chemotherapy and imatinib mesylate in treating children who have relapsed acute lymphoblastic leukemia.
| Condition | Intervention |
|---|---|
|
L1 Childhood Acute Lymphoblastic Leukemia L2 Childhood Acute Lymphoblastic Leukemia Non-T, Non-B Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia T-cell Childhood Acute Lymphoblastic Leukemia |
Drug: cytarabine Drug: methotrexate Drug: vincristine sulfate Drug: prednisone Drug: pegaspargase Drug: doxorubicin hydrochloride Drug: imatinib mesylate Drug: cyclophosphamide Drug: etoposide Biological: filgrastim Drug: leucovorin calcium Drug: asparaginase Drug: therapeutic hydrocortisone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intensive Induction Therapy for Children With Acute Lymphoblastic Leukemia (ALL) Who Experience a Bone Marrow Relapse |
Resource links provided by NLM:
Drug Information available for:
Hydrocortisone acetate
Cyclophosphamide
Hydrocortisone
Prednisone
Methotrexate
Hydrocortisone sodium succinate
Cytarabine
Hydrocortisone cypionate
Leucovorin calcium
Vincristine sulfate
Asparaginase
Hydrocortisone butyrate
Sulfate ion
Methotrexate sodium
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Hydrocortisone valerate
Levoleucovorin
Hydrocortisone probutate
Etoposide phosphate
Filgrastim
Pegaspargase
Lenograstim
Granulocyte colony-stimulating factor
Imatinib
Imatinib mesylate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Feasibility assessed by excessive early deaths, induction failures, and early relapses [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]
- Toxicity assessed using CTC version 2.0 [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]Will be tabulated in detail.
Secondary Outcome Measures:
- Overall remission reinduction (CR2) rate [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]
- EFS [ Time Frame: 4 months ] [ Designated as safety issue: No ]The Kaplan-Meier method will be used.
- MRD [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]The percentage of MRD positive patients will be estimated at the end of each block. Cox regression will be utilized to correlate MRD values with EFS.
- Feasibility of combining intensive re-induction therapy with imatinib mesylate [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]Will be determined using descriptive statistics due to the small sample size.
- Percentage of patients who were able to complete the triple re-induction therapy with imatinib mesylate [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]Will be estimated.
| Estimated Enrollment: | 126 |
| Study Start Date: | January 2003 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
See detailed description.
|
Drug: cytarabine
Given IT
Other Names:
Drug: methotrexate
Given IT
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: prednisone
Given PO
Other Names:
Drug: pegaspargase
Given IM
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: imatinib mesylate
Given PO
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Biological: filgrastim
Given SC
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: asparaginase
Given IM
Other Names:
|
|
Experimental: Arm II
See detailed description.
|
Drug: cytarabine
Given IT
Other Names:
Drug: methotrexate
Given IT
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: prednisone
Given PO
Other Names:
Drug: pegaspargase
Given IM
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: imatinib mesylate
Given PO
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Biological: filgrastim
Given SC
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: asparaginase
Given IM
Other Names:
Drug: therapeutic hydrocortisone
Given IT
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow), with or without associated extramedullary disease; this includes patients who are Philadelphia chromosome-positive
- Shortening fraction of >= 28% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
- Cumulative prior anthracycline exposure of =< 350 mg/m^2 (each 10 mg/m^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m^2 of daunorubicin or adriamycin)
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with B-cell ALL (L3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
- Patients with Down syndrome are excluded due to the administration of methotrexate in Block 2
Patients who have undergone prior stem cell transplantation (SCT) are ineligible if:
- They received SCT less than 12 months prior to study entry
- They are still receiving immunosuppression for the treatment of graft-versus-host disease (GVHD)
- They have active fungal infection at time of study entry
- They have had invasive filamentous fungal infection at any time post-SCT
- Pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
- Patients with prior isolated extramedullary relapse are ineligible
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00049569 History of Changes |
| Other Study ID Numbers: | NCI-2012-01798, AALL01P2, COG-AALL01P2, CDR0000258120, U10CA098543 |
| Study First Received: | November 12, 2002 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Pegaspargase Imatinib Asparaginase Cyclophosphamide Cytarabine Doxorubicin |
Etoposide Methotrexate Prednisone Vincristine Lenograstim Cortisol succinate Hydrocortisone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone Hydrocortisone-17-butyrate Leucovorin Levoleucovorin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013