Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00061945|
Recruitment Status : Completed
First Posted : June 6, 2003
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Undifferentiated Leukemia B-cell Adult Acute Lymphoblastic Leukemia B-cell Childhood Acute Lymphoblastic Leukemia L1 Adult Acute Lymphoblastic Leukemia L1 Childhood Acute Lymphoblastic Leukemia L2 Adult Acute Lymphoblastic Leukemia L2 Childhood Acute Lymphoblastic Leukemia Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia T-cell Adult Acute Lymphoblastic Leukemia T-cell Childhood Acute Lymphoblastic Leukemia Untreated Adult Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia||Drug: allopurinol Drug: cyclophosphamide Drug: daunorubicin hydrochloride Drug: vincristine sulfate Drug: dexamethasone Drug: asparaginase Biological: filgrastim Drug: imatinib mesylate Drug: methotrexate Drug: cytarabine Drug: trimethoprim-sulfamethoxazole Drug: mercaptopurine Drug: leucovorin calcium Biological: alemtuzumab Drug: acyclovir Other: laboratory biomarker analysis Other: pharmacological study||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H (NSC #715969, IND #10864) During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia (ALL)|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||October 2012|
Experimental: Treatment (alemtuzumab and combination chemotherapy)
See detailed description.
Drug: daunorubicin hydrochloride
Drug: vincristine sulfate
Given PO and as eye drops
Drug: imatinib mesylate
Given IT, IV, and PO
Drug: leucovorin calcium
Given IV and PO
Other: laboratory biomarker analysis
Other: pharmacological study
- Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I) [ Time Frame: 6 weeks ]The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.
- Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II) [ Time Frame: 8 months ]The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.
- Modulation of Minimal Residual Disease During Treatment With Alemtuzumab (Phase II) [ Time Frame: Up to 10 years ]
- Disease-free Survival (Phase II) [ Time Frame: 3 years ]Will be estimated using the Kaplan-Meier method with confidence intervals presented.
- Overall Survival (Phase II) [ Time Frame: 3 years ]Will be estimated using the Kaplan-Meier method with confidence intervals presented.
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): NCT00061945
|United States, Illinois|
|Cancer and Leukemia Group B|
|Chicago, Illinois, United States, 60606|
|Principal Investigator:||Wendy Stock||Cancer and Leukemia Group B|