Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia
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| ClinicalTrials.gov Identifier: NCT00002756 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : February 14, 2014
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RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them as induction intensification may kill more cancer cells.
PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia | Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate | Phase 2 |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 221 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Induction Intensification in Infant ALL: A Children's Oncology Group Study |
| Study Start Date : | June 1996 |
| Actual Primary Completion Date : | September 2007 |
| Actual Study Completion Date : | March 2012 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Chemo (Reduced Induction) No BMT (Open February 2004) |
Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate |
- Feasibility of intensification
- Event-free survival
- Comparison of event-free survival rates in infants with and without leukemic blasts translocations
- Correlation of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome
- Clinical prognostic features associated with outcome
- Correlation of biologic characteristics of leukemia cells at diagnosis with outcome
- Patterns of gene expression
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| Ages Eligible for Study: | up to 1 Year (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia
- No infants less than 36 weeks' gestation
- CNS or testicular disease permitted
- No B-cell ALL or acute myeloid leukemia
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Previously untreated except for the following:
- Steroid treatment within 48 hours of diagnosis allowed with physical examination and differential CBC immediately prior to beginning steroids
- Concurrent registration on protocol POG-9900 (ALL classification study) required
- Patients registered on POG-9407 are eligible for the pharmacokinetic part of the study
PATIENT CHARACTERISTICS:
Age:
- Under 1 at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No uncontrolled infection
- Adequate major organ function
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- See Disease Characteristics
- No concurrent chronic steroid treatment
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No other concurrent anticancer therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002756
Show 140 Study Locations
| Study Chair: | Zoann E. Dreyer, MD | Texas Children's Cancer Center |
Publications of Results:
Other Publications:
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002756 History of Changes |
| Other Study ID Numbers: |
P9407 COG-P9407 ( Other Identifier: Children's Oncology Group ) POG-9407 ( Other Identifier: Pediatric Oncology Group ) CDR0000064693 ( Other Identifier: Clinical Trials.gov ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | February 14, 2014 |
| Last Verified: | February 2014 |
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untreated childhood acute lymphoblastic leukemia acute undifferentiated leukemia |
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Leukemia Neoplasms by Histologic Type Neoplasms Cytarabine Prednisone Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Cyclophosphamide Methotrexate Etoposide Vincristine Daunorubicin Asparaginase |
Mercaptopurine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites |