Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Children With Acute Lymphoblastic Leukemia
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022737
First received: August 10, 2001
Last updated: March 15, 2013
Last verified: November 2012
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Purpose
This phase II trial is studying how well combination chemotherapy with or without donor peripheral stem cell transplant works in treating children with acute lymphoblastic leukemia. Giving combination chemotherapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets
| Condition | Intervention | Phase |
|---|---|---|
|
Childhood Acute Lymphoblastic Leukemia in Remission Recurrent Childhood Acute Lymphoblastic Leukemia |
Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: ifosfamide Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: umbilical cord blood transplantation Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Children's Oncology Group Pilot Study for the Treatment of Very High Risk Acute Lymphoblastic Leukemia in Children and Adolescents (Imatinib (STI571, GLEEVEC) NSC#716051/IND#61135) |
Resource links provided by NLM:
MedlinePlus related topics:
Bone Marrow Transplantation
Cancer
Chronic Lymphocytic Leukemia
Leukemia
Drug Information available for:
Dexamethasone
Cyclophosphamide
Mercaptopurine
Methotrexate
Cytarabine
Dexamethasone acetate
Leucovorin calcium
Vincristine sulfate
Dexamethasone sodium phosphate
Ifosfamide
Asparaginase
Sulfate ion
Methotrexate sodium
Daunorubicin
Daunorubicin hydrochloride
Etoposide
Cyclosporine
Levoleucovorin
Etoposide phosphate
Filgrastim
Pegaspargase
Lenograstim
Granulocyte colony-stimulating factor
Imatinib
Imatinib mesylate
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Feasibility, in terms of patient accrual [ Time Frame: Up to 1.75 years ] [ Designated as safety issue: No ]As a target goal, we wish to enroll at least 80% of the potential available patients. The accrual duration for this pilot study will be based on accruing adequate numbers to complete the dose escalation study in the Ph+ subset. The planned study accrual duration should be approximately 1.75 years.
- Feasibility, in terms of incidence of adverse events graded according to NCI CTC v 2.0 [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]The use of imatinib as given in combination with other agents in a particular cohort will be considered feasible initially if 5 or more of the first 6 evaluable patients complete the phase(s) without evidence of grade 3 or 4 targeted toxicities.
Secondary Outcome Measures:
- Event-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]Estimated with 90% confidence interval.
| Enrollment: | 220 |
| Study Start Date: | October 2002 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
See Design Details.
|
Biological: filgrastim
Given SC
Other Names:
Drug: asparaginase
Given IM
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cyclosporine
Given IV
Other Names:
Drug: cytarabine
Given IT and IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Given orally
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: ifosfamide
Given IV
Other Names:
Drug: imatinib mesylate
Given orally
Other Names:
Drug: leucovorin calcium
Given IV or orally
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: methotrexate
Given IT, IV, and orally
Other Names:
Drug: pegaspargase
Given IM
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Procedure: allogeneic bone marrow transplantation
Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation
Other Names:
Procedure: peripheral blood stem cell transplantation
Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation
Other Names:
Procedure: umbilical cord blood transplantation
Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation
Other Names:
Radiation: radiation therapy
Undergo radiation therapy
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:
- Diagnosis of acute lymphoblastic leukemia
- Received prior front-line therapy on a Pediatric Oncology Group (POG),Children's Cancer Group (CCG), or Central Oncology Group (COG) study
- Received induction therapy comprising vincristine, asparaginase, prednisone/dexamethasone, and daunorubicin as in CCG, POG, or COG protocols
M1 or M2 bone marrow status after front-line induction therapy and presenting with at least 1of the following:
- Philadelphia chromosome positive (Ph+) with t(9;22)(q34;q11) by cytogenetics or fluorescence in situ hybridization
- bcr-abl fusion transcript by reverse transcription polymerase chain reaction
- Hypodiploid with less than 44 chromosomes and/or DNA index less than0.81
- MLL translocation (11q23) by cytogenetics and a slow early response (SER) to induction therapy, defined as at least 5% blasts at day 15 of induction and/or at least .1% minimal residual disease (MRD) after induction therapy
Failed to achieve remission after front-line induction therapy
- M3 bone marrow status (greater than 25% blasts) after induction therapy
- M2 bone marrow status (5-25% blasts) or at least 1% MRD after induction therapy and M2 or M3or at least 1% MRD after consolidation therapy (CCG studies) or extended induction therapy (POG or COG studies)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent prophylactic cranial radiotherapy
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022737 History of Changes |
| Other Study ID Numbers: | NCI-2012-01862, AALL0031, U10CA098543, CDR0000068859 |
| Study First Received: | August 10, 2001 |
| Last Updated: | March 15, 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 6-Mercaptopurine Cytarabine Methotrexate Cyclophosphamide Cyclosporins Cyclosporine |
Isophosphamide mustard Pegaspargase Imatinib Asparaginase Daunorubicin Dexamethasone Etoposide Ifosfamide Vincristine BB 1101 Lenograstim Dexamethasone acetate Dexamethasone 21-phosphate Leucovorin Levoleucovorin |
ClinicalTrials.gov processed this record on May 16, 2013